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Page 1: Spontaneous Report of Adverse Drug Reaction 2004thaihpvc.fda.moph.go.th/thaihvc/Public/News/uploads/hpvc... · 2013-06-27 · spontaneous report of adverse drug reaction 200417 anaphylactic
Page 2: Spontaneous Report of Adverse Drug Reaction 2004thaihpvc.fda.moph.go.th/thaihvc/Public/News/uploads/hpvc... · 2013-06-27 · spontaneous report of adverse drug reaction 200417 anaphylactic

Spontaneous Report of Adverse Drug Reaction 2004

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Spontaneous Report of Adverse Drug Reaction 2004

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Spontaneous Report of Adverse Drug Reaction 2004

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Spontaneous Reporting System Intensive Clinical Trial

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Spontaneous Report of Adverse Drug Reaction 2004 17

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ANAPHYLACTIC SHOCK ACTINOMYCINES

ALLOPURINOL

AMIDOTRIZOIC ACID + MEGLUMINE

AMOXYCILLIN

AMOXYCILLIN + CLAVULANIC ACID

AMPICILLIN

ASPARAGINASE

ASPIRIN (ACETYLSALICYLIC ACID)

CARBAMAZEPINE

CARBOPLATIN

CEFALEXIN

CEFAZOLIN

CEFOTAXIME SODIUM

CEFTRIAXONE

CEFTRIAXONE SODIUM

CELECOXIB

CHLORAMPHENICOL

CHLORPHENIRAMINE + ACETYLSALICYLIC ACID

CHLORPHENIRAMINE + PARACETAMOL +

PHENYLEPHRINE

CIMETIDINE

CIPROFLOXACIN

CLOXACILLIN

CLOXACILLIN FOR INJECTION

CO-DERGOCRINE MESYLATE

DAPSONE

DIAZEPAM

DICLOFENAC

DICLOFENAC FOR INJECTION

DICLOXACILLIN

EQUINE RABIES IMMUNOGLOBULIN

ERYTHROMYCIN

ETOPOSIDE

FLOCTAFENINE

FLUNARIZINE

FRESH FROZEN PLASMA

GEMFIBROZIL

HYOSCINE-N-BUTYLBROMIDE

IBUPROFEN

INDOMETHACIN

IOPAMIDE

IOXITALAMIC ACID

ANAPHYLACTIC SHOCK

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ANAPHYLACTIC SHOCK

ANAPHYLACTOIDREACTION

KETOCONAZOLELIDOCAINELINCOMYCINLORAZEPAMMEFENAMIC ACIDMEGLUMINE AMIDOTRIZOATEMEGLUMINE IOXITALAMATEMETAMIZOLE (DIPYRONE)METHIMAZOLE (THIAMAZOLE)METOCLOPRAMIDEMETRONIDAZOLEMORPHINENAPROXENNICLOSAMIDENORFLOXACINOMEPRAZOLEORPHENADRINE CHLORIDEORPHENADRINE CITRATE+PARACETAMOLOXYTETRACYCLINEPARACETAMOLPARACETAMOL + CHLORPHENIRAMINEPENICILLIN + STREPTOMYCINPENICILLIN G (BENZYLPENICILLIN)PENICILLIN G POTASSIUM (BENZYLPENICILLIN

POTASSIUM)PENICILLIN G SODIUM (BENZYLPENICILLIN

SODIUM)PENICILLIN V (PHENOXYMETHYLPENICILLIN)PENICILLINSPHENAZOPYRIDINE + SULFAMETHIZOLE +

TETRACYCLINEPIROXICAMPROCAINE PENICILLIN GPROPANOLOL, COMBINATIONSRANITIDINESTREPTOKINASESULFAMETHOXAZOLE + TRIMETHOPRIMTETRACAINETETRACYCLINETOLPERISONETRAMADOLTRIAMCINOLONETRIPROLIDINE + PSEUDOEPHEDRINEVITAMIN KAMOXYCILLINAMOXYCILLIN + CLAVULANIC ACIDAMPICILLINCEFPIROMECEFTRIAXONECEFTRIAXONE DISODIUMCELECOXIBCIPROFLOXACINCLINDAMYCIN FOR INJECTIONCLOXACILLIN

DIAZEPAMDICLOFENACDICLOXACILLINIBUPROFENINDOMETHACINLIDOCAINEMEFENAMIC ACIDMEGLUMINE IOXITALAMATEMEGLUMINE IOXITALAMATE + SODIUMIOXITALAMATEPARACETAMOLPENICILLIN V (PHENOXYMETHYLPENICILLIN)PENICILLINSRABIES IMMUNOGLOBULIN (ERIG, RABUMAN

BERNA)RABIES VACCINE INACTIVATED (PCEC)TETRACYCLINESTRIAMCINOLONETRIPROLIDINE + PSEUDOEPHEDRINEVITAMIN B1 - B6 - B12ACYCLOVIRALLOPURINOLAMOXYCILLINCARBAMAZEPINECEFOTAXIME SODIUMCEFTRIAXONECEFTRIAXONE SODIUMCLOXACILLINCOLCHICINECONJUGATED ESTROGENDANAZOLIMIPENEM + CILASTATINIMIPENEM + CILASTATINLINCOMYCINRITONAVIR + LOPINAVIRSULFAMETHOXAZOLE + TRIMETHOPRIMALLOPURINOLASPIRIN (ACETYLSALICYLIC ACID)CARBAMAZEPINECEFTRIAXONECLARITHROMYCINDICLOFENACETHAMBUTOLHYDROCHLOROTHIAZIDEIBUPROFENINDOMETHACINLAMIVUDINEMEFENAMIC ACIDPARACETAMOLPIROXICAMRIFAMPICIN + ISONIAZID + PYRAZINAMIDESTAVUDINESTAVUDINE + LAMIVUDINE+NEVIRAPINESULFADIAZINE

ANAPHYLACTOIDREACTION

DEATH

TOXIC EPIDERMALNECROLYSIS

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Spontaneous Report of Adverse Drug Reaction 2004 19

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TOXIC EPIDERMALNECROLYSIS

ERYTHEMAMULTIFORME

SULFAMETHOXAZOLE + TRIMETHOPRIMTETRACYCLINEALLOPURINOLAMOXYCILLINAMOXYCILLIN + CLAVULANIC ACIDAMPHOTERICIN B (ANTIMYCOTICS FOR

SYSTEMIC USE)AMPICILLINAMPICILLIN FOR INJECTIONATENOLOLAZATHIOPRINEAZITHROMYCINBROMHEXINECARBAMAZEPINECEFALEXINCEFAZOLINCEFOTAXIME SODIUMCEFTAZIDIMECEFTRIAXONECEFTRIAXONE SODIUMCELECOXIBCEPHALOSPORINS AND RELATE SUBSTANCESCHLORAMPHENICOLCLINDAMYCINCLOXACILLINCLOXACILLIN FOR INJECTIONDAPSONEDEXTROMETHORPHANDEXTROMETHORPHAN + GUAIFENESIN +

PSEUDOEPHEDRINE + DIPHENHYDRAMINEDIAZEPAMDICLOFENACDICLOFENAC FOR INJECTIONDICLOXACILLINDIMENHYDRINATEDOXYCYCLINEEFAVIRENZENALAPRILERYTHROMYCINERYTHROMYCIN ESTOLATEETHAMBUTOLFEXOFENADINEFLUCONAZOLEFUROSEMIDEGLICLAZIDEGRISEOFULVINHYDROCHLOROTHIAZIDEIBUPROFENIMIPENEM + CILASTATININDAPAMIDEINDOMETHACINISONIAZIDLEVOFLOXACINLINCOMYCIN

MEFENAMIC ACIDMETAMIZOLE (DIPYRONE)METFORMINMETRONIDAZOLENEVIRAPINENIMESULIDENORFLOXACINNYSTATIN + DIIODOHYDROXYQUINOLINE +

BENZALKONIUM CHLORIDE(GYNECOLOGICAL)

OFLOXACINOMEPRAZOLEPARACETAMOLPARACETAMOL + CHLORPHENIRAMINEPARACETAMOL + ORPHENADRINE CITRATEPARECOXIBPENICILLIN G (BENZYLPENICILLIN)PENICILLIN G SODIUM (BENZYLPENICILLIN

SODIUM)PENICILLIN V (PHENOXYMETHYLPENICILLIN)PENICILLINSPHENOBARBITALPHENYTOINPIPERACILLINPIROXICAMPROPYLTHIOURACILPYRAZINAMIDERIFAMPICINROXITHROMYCINSALBUTAMOLSIMVASTATINSTAVUDINE+LAMIVUDINE+NEVIRAPINESULFADIAZINE AND TRIMETHOPRIMSULFAMETHOXAZOLE + TRIMETHOPRIMSULFONAMIDES AND TRIMETHOPRIMTETRACYCLINETOLPERISONETRADITIONAL MEDICINEVALDECOXIBVANCOMYCINVIRAL VACCINESVITAMIN B-COMPLEX, PLAINPENICILLIN G SODIUM (BENZYLPENICILLIN

SODIUM)ALLOPURINOLAMITRIPTYLINEAMOXYCILLIN + CLAVULANIC ACIDAMPICILLIN FOR INJECTIONBEZAFIBRATECARBAMAZEPINECLOXACILLIN FOR INJECTIONDEXAMETHASONEDICLOXACILLINDIGOXIN

ERYTHEMAMULTIFORME

GRANULOCYTOPENIA

HEPATITIS

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⌦⌫

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HEPATITIS

RENAL FAILURE ACUTE

STEVENS JOHNSONSYNDROME

EFAVIRENZETHAMBUTOLFENOFIBRATEFUROSEMIDEGEMFIBROZILHALOTHANEHYDROCHLOROTHIAZIDEINTERFERON BETA-1AISONIAZIDKETOCONAZOLELAMIVUDINEMETHIMAZOLE (THIAMAZOLE)METHOTREXATENEVIRAPINENIMESULIDEOFLOXACINPENICILLIN G SODIUM (BENZYLPENICILLIN

SODIUM)PHENOBARBITALPHENYLBUTAZONEPHENYTOINPROPRANOLOLPROPYLTHIOURACILPYRAZINAMIDERIFAMPICINRIFAMPICIN + ISONIAZID + PYRAZINAMIDERIFAMPICIN + ETHAMBUTOL + ISONIAZID +

PYRAZINAMIDESIMVASTATINSTAVUDINESTAVUDINE + LAMIVUDINE + NEVIRAPINESULFAMETHOXAZOLE + TRIMETHOPRIMTHEOPHYLLINETIONSPORA CRISPA (L.) ()AMIKACINAMPHOTERICIN B (ANTIMYCOTICS FOR

SYSTEMIC USE)BEZAFIBRATECEFTRIAXONECLOXACILLINCYCLOSPORINEDICLOFENACENALAPRILFENOFIBRATEIBUPROFENMETHOTREXATENETILMICINROFECOXIBSIMVASTATINTETRACYCLINEURSODEOXYCHOLIC ACIDVALDECOXIBACETAZOLAMIDEACYCLOVIR

ALLOPURINOLAMITRIPTYLINEAMOXYCILLINAMOXYCILLIN + CLAVULANIC ACIDAMPICILLINASPIRIN (ACETYLSALICYLIC ACID)ATENOLOLBELLADONNA ALKALOIDS, SEMISYNTHETIC,

QUARTERNARY AMMONIUM COMPOUNDSBROMHEXINECALCIUM CARBONATECARBAMAZEPINECEFALEXINCEFAZOLINCEFDINIRCEFEPIMECEFOPERAZONE + SULBACTAM (SULPERAZONE)CEFOTAXIME SODIUMCEFTAZIDIMECEFTRIAXONECEFTRIAXONE DISODIUMCELECOXIBCHLORAMPHENICOLCHLOROQUINECHLORPHENIRAMINECHLORPHENIRAMINE + PARACETAMOL +

PHENYLEPHRINECHLORPROMAZINECIMETIDINECIPROFLOXACINCLOTRIMAZOLECLOXACILLINCLOXACILLIN FOR INJECTIONCOLCHICINEDANAZOLDAPSONEDEXTROMETHORPHANDICLOFENACDICLOXACILLINDIMENHYDRINATEDOXYCYCLINEEFAVIRENZENALAPRILERYTHROMYCINERYTHROMYCIN ESTOLATEETHAMBUTOLFERROUS FUMARATE+VITAMIN B1-B2-B6-B12 +

VIT. C + VIT. D + CALCIUM PHOSPHATEDIBASIC

FLUCONAZOLEFLUNARIZINEFUROSEMIDEGLIBENCLAMIDEGLICLAZIDE

STEVENS JOHNSONSYNDROME

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Spontaneous Report of Adverse Drug Reaction 2004 21

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STEVENS JOHNSONSYNDROME

GRISEOFULVINHYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE + AMILORIDEHYDROXYCHLOROQUINEHYDROXYZINEIBUPROFENIMIPENEM + CILASTATININDOMETHACINISONIAZIDLAMIVUDINELINCOMYCINMEBENDAZOLEMELOXICAMMETAMIZOLE (DIPYRONE)METRONIDAZOLEMIANSERINMULTIVITAMINSNAPROXENNETILMICINNEVIRAPINENICOTINIC ACIDNIFEDIPINENORFLOXACINNORTRIPTYLINEOFLOXACINOMEPRAZOLEORPHENADRINE CITRATEPARACETAMOLPARACETAMOL + ORPHENADRINE CITRATEPENICILLAMINEPENICILLIN G (BENZYLPENICILLIN)PENICILLIN G SODIUM (BENZYLPENICILLIN

SODIUM)

PENICILLIN V (PHENOXYMETHYLPENICILLIN)PHENACETINPHENOBARBITALPHENYLBUTAZONEPHENYTOINPIROXICAMPREDNISOLONEPROPYLTHIOURACILPYRAZINAMIDEQUININERANITIDINERIFAMPICINRIFAMPICIN + ISONIAZID + PYRAZINAMIDEROXITHROMYCINSODIUM VALPROATESTAVUDINESTAVUDINE + LAMIVUDINE+NEVIRAPINESTREPTOMYCINSULBACTAM + CEFOPERAZONE SODIUMSULFADIAZINESULFAMETHOXAZOLESULFAMETHOXAZOLE + TRIMETHOPRIMSULFAMETHOXYPARAZINE + TRIMETHOPRIMSULFAMETHOXYPYRIDAZINETETRACYCLINETOBRAMYCINTOLPERISONETRAMADOLTRIPROLIDINE + PSEUDOEPHEDRINEVALDECOXIBVANCOMYCINVERAPAMIL

STEVENS JOHNSONSYNDROME

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⌫ ⌦

AMOXYCILLINSULFAMETHOXAZOLE + TRIMETHOPRIMCEFTRIAXONEIBUPROFENCLOXACILLINDICLOFENACSTAVUDINE+LAMIVUDINE+NEVIRAPINEAMPICILLINPENICILLIN V (PHENOXYMETHYLPENICILLIN)DICLOXACILLINPARACETAMOLNORFLOXACINPHENYTOINTETRACYCLINEPIROXICAMAMOXYCILLIN+CLAVULANIC ACIDPENICILLIN G SODIUM (BENZYLPENICILLIN SODIUM)RIFAMPICINCEFOTAXIME SODIUMCIPROFLOXACINALLOPURINOLCEFAZOLINMETRONIDAZOLEASPIRIN (ACETYLSALICYLIC ACID)ENALAPRIL

1,6581,344

915874785734482396395364342307280265248245235214197195180179177172170

7.886.394.354.153.733.492.291.881.881.731.631.461.331.261.181.161.121.020.940.930.860.850.840.820.81

1.2.3.4.5.6.7.8.9.

10.11.12.13.14.15.16.17.18.19.20.21.22.23.24.25.

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Spontaneous Report of Adverse Drug Reaction 2004 23

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METHYLPHENIDATEETORICOXIBEFAVIRENZROSUVASTATINTRAMADOL+PARACETAMOLVALDECOXIBPARECOXIBRISPERIDONEGEFITINIBPEGINTERFERON ALPHA-2BINFLUENZA VACCINESTACROLIMUSRITONAVIR+LOPINAVIRSIBUTRAMINEERTAPENEMVARDENAFILINSULINS, LONG-ACTINGFOSINOPRIL+DIURETICDIPYRIDAMOLE + ACETYLSALIC ACIDOLANZAPINEERYTHROPOIETIN ALFANORELGESTROMIN AND ESTROGENINTERFERON BETA-1AREBAMIPIDEBICALUTAMIDE

9940363433272322222017161512119988766654

16.846.806.125.785.614.593.913.743.743.402.892.722.552.041.871.531.531.361.361.191.021.021.020.850.68

1.2.3.4.5.6.7.8.9.

10.11.12.13.14.15.16.17.18.19.20.21.22.23.24.25.

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⌦24

⌫ ⌦

⌫ ⌦

⌫ ⌦ ⌫⌦

<=12-1415-3031-4546-60>=60

527995

1,3452,0051,3271,350

267

367820

2,1553,0012,3021,949

343

156536

33

8951,8203,5065,0113,6323,305

643

7,816 10,937 59 18,812

0.769.678.64

26.6419.3117.513.42

100.00

3,15652732

3,715

5,28867933

6,000

115-

16

2,3231,58020

2,923

2,7841,90525

4,714

561

12

1055122

178

1396420

223

17131

31

13,8284,830154

18,812

73.5125.680.82

100.00

⌫⌫

⌦⌫

1,993

3167501

3

3

475192

3,411

5021,097

-

6

2

699283

7

14-

-

-

31

2,591

4624856

7

17

171184

3,078

5066656

9

23

202225

7

1--

-

-

13

53

1020-

-

-

491

79

9211

2

-

9102

12

44-

1

-

73

11,231

1,8113,04614

28

45

1,5531,084

59.70

9.6316.190.07

0.15

0.24

8.265.76

3,715 6,000 16 3,923 4,714 12 178 223 31 18,812 100.00

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Spontaneous Report of Adverse Drug Reaction 2004 25

⌫ ⌫⌫⌦

⌫ ⌫⌫⌦

GENERAL ANTIINFECTIVES, SYSTEMICMUSCULO-SKELETAL SYSTEMCENTRAL NERVOUS SYSTEMALIMENTARY TRACT AND METABOLISMCARDIOVASCULAR SYSTEMRESPIRATORY SYSTEMBLOOD AND BLOOD FORMING ORGANSGENITO URINARY SYSTEM AND SEX HORMONESVARIOUSANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGSSYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONESDERMATOLOGICALSANTIPARASITIC PRODUCTSSENSORY ORGANSCOMPLEMENTARY MEDICINE

12,1133,1652,9061,037

8756343392831801611549450318

54.9814.3713.194.713.972.881.541.280.820.730.700.430.230.140.04

22,030 100.00

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⌫ ⌫⌫⌦

ALIMENTARY TRACT AND METABOLISMANABOLICS, SYSTEMICANTACIDS, ANTIFLATULENTS AND ANTI-PEPTIC ULCERANTSANTIDIABETIC THERAPYANTIDIARRHOEALS, INTESTINAL ANTIINFLAMMATORY/ ANTIINFECTIVES AGENTSANTIEMETICS AND ANTINAUSEANTSANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTSCHOLAGOGUES AND HEPATIC PROTECTORSDIGESTIVES, INCL. ENZYMESGASTROINTESTINAL ANTISPASMODICS AND ANTICHOLINERGICSLAXATIVESMINERAL SUPPLEMENTSSTOMATOLOGICALS, MOUTH PREPARATIONSTONICSVITAMINS

ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGSCYTOSTATICS DRUGSHORMONE THERAPYIMMUNOSTIMULANTSIMMUNOSUPPRESSIVE AGENTS

ANTIPARASITIC PRODUCTSANTHELMINTICSANTIPROTOZOALS

BLOOD AND BLOOD FORMING ORGANSANTIANAEMIC PREPARATIONSANTICOAGULANTSANTIHAEMORRHAGICSCHOLESTEROL REDUCERS, ANTIATHEROMA PREPARATIONSOTHER HAEMATOLOGICAL AGENTS, INCL.FIBRINOLYTICS AND HYALURONIDASEPLASMA SUBSTITUTES AND PERFUSION SOLUTIONS

CARDIOVASCULAR SYSTEMAGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEMBETA BLOCKING AGENTSCALCIUM CHANNEL BLOCKERS

4276162145551767

263121517

681,037

1257

1019

161

193150

517810

1284134

339

359946

0.3926.5915.6113.975.301.640.580.67

25.341.161.450.100.676.55

100.00

77.644.356.21

11.80100.00

38.0062.00

100.00

14.9122.812.92

37.4211.999.94

100.00

3.9811.265.23

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Spontaneous Report of Adverse Drug Reaction 2004 27

CARDIOVASCULAR SYSTEMCARDIAC THERAPYDIURETICSHYPOTENSIVESPERIPHERAL VASODILATORSSERUM LIPID REDUCING AGENTSVASOPROTECTIVES

CENTRAL NERVOUS SYSTEMANAESTHETICSANALGESICSANTIEPILEPTICSANTI-PARKINSON DRUGSOTHER CNS DRUGS, INCL. PARASYMPATHOMIMETICSPSYCHOANALEPTICSPSYCHOLEPTICS

COMPLEMENTARY MEDICINEALIMENTARY TRACT AND METABOLISMRESPIRATORY SYSTEMOTHER COMPLEMENTARY MEDICINE

DERMATOLOGICALSANTI-ACNE PREPARATIONSANTIBIOTICS AND CHEMOTHERAPEUTICS, DERMATOLOGICALSANTIFUNGALS, DERMATOLOGICALANTIPRURITICS, INCL. ANTIHISTAMINES, ANAESTHETICS, etc.ANTISEPTICS AND DISINFECTANTSCORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONSOTHER DERMATOLOGICAL PREPARATIONS

GENERAL ANTIINFECTIVES, SYSTEMICANTIVIRALS FOR SYSTEMIC USEIMMUNE SERA AND IMMUNOGLOBULINSOTHER ANTIINFECTIVES, INCL. LEPROSTATICSSYSTEMIC ANTIBIOTICSSYSTEMIC ANTIMYCOTICS, EXCL. GRISEOFULVINSYSTEMIC CHEMOTHERAPEUTICSTUBERCULOSTATICS, EXCL. STREPTOMYCINVACCINE

7721129961447

875

1831,066

731201

9208526

2,906

2158

57

552

1539

94

1,006421

7,986152

2,130684176

12,113

8.7624.0034.026.945.010.80

100.00

6.2636.4625.006.870.317.11

17.99100.00

25.0012.5062.50

100.00

5.217.29

57.292.08

15.633.139.38

100.00

8.260.340.01

65.581.25

17.495.621.45

100.00

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GENITO URINARY SYSTEM AND SEX HORMONESGYNAECOLOGICAL ANTIINFECTIVES AND ANTISEPTICSOTHER GYNAECOLOGICALSSEX HORMONES AND STIMULANTS OF THE GENITAL SYSTEMUROLOGICALS

MUSCULO-SKELETAL SYSTEMANTIGOUT PREPARATIONSANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTSMUSCLE RELAXANTSOTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEMTOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

RESPIRATORY SYSTEMANTI - ASTHMATICSCOUGH AND COLD PREPARATIONSNASAL PREPARATIONSOTHER RESPIRATORY SYSTEM PRODUCTSSYSTEMIC ANTIHISTAMINESTHROAT PREPARATIONS

SENSORY ORGANSOPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONSOPHTHALMOLOGICALSOTOLOGICALS

SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONESCALCIUM HOMEOSTASISPITUITARY HORMONESSYSTEMIC CORTICOSTEROIDSTHYROID THERAPY

VARIOUSALL OTHER NON-THERAPEUTIC PRODUCTSALL OTHER THERAPEUTIC PRODUCTSCONTRAST MEDIADIAGNOSTIC AGENTS

214133424

285

2182,713

227145

3,165

162154193

2991

634

3271

31

34

8166

154

43

31143180

75.094.56

11.938.42

100.00

6.8685.407.150.440.16

100.00

25.3924.142.980.47

46.870.16

100.00

9.6887.103.23

100.00

1.952.60

52.6042.86

100.00

2.211.66

17.1379.01

100.00

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Spontaneous Report of Adverse Drug Reaction 2004 29

⌫ ⌫⌫⌦

ABACAVIR

ACARBOSE

ACETAZOLAMIDE

ACETYLCYSTEINE

ACTINOMYCINES

ACTIVATED CHARCOAL + SODIUM BICARBONATE +PEPPERMINT OIL

ACYCLOVIR

- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1

- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 2 - - 2- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

FIXED ERUPTIONHYPERSENSITIVITYDIZZINESSNAUSEAVOMITINGANAESTHESIA LOCALANOREXIADERMATITIS EXFOLIATIVEDIZZINESSEYE ABNORMALITYFIXED ERUPTIONPAINPRURITUSRASHRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMEURTICARIABULLOUS ERUPTIONDROWSINESSDYSPNOEANAUSEAOEDEMA MOUTHPRURITUSRASHRASH ERYTHEMATOUSSTOMATITISURTICARIAVOMITINGANAPHYLACTIC SHOCKNAUSEATHROMBOCYTOPENIADIARRHOEAPRURITUSCONJUNCTIVITISFACE OEDEMAFIXED ERUPTIONHEADACHEMACULAR RASHNEPHRITISOEDEMAPALPITATION

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ACYCLOVIR

ACYCLOVIR FOR TOPICALADRENALINEALBENDAZOLE

ALBUMIN

ALCOHOL 70% FOR TOPICAL

ALENDRONATE SODIUM

ALFUZOSIN

ALLOPURINOL

- - 1 - 1- - 3 - 3- 2 2 - 4- - 1 - 1- - 2 - 2

- 1 1 - 2- - 1 - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - - - 11 4 1 - 6- 2 - - 21 - - - 1- 1 1 - 22 13 1 - 16- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEURTICARIAURTICARIARASHANGIOEDEMARASH ERYTHEMATOUSDYSPNOEAERYTHEMAHYPOTENSIONPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULAROEDEMA GENERALISEDPRURITUSRASHRASH ERYTHEMATOUSBONE PAINDYSPNOEAHAEMATURIAMYALGIANAUSEAPAINURTICARIAVOMITINGFATIGUEPALPITATIONPENILE SWELLINGPRURITUSRASH ERYTHEMATOUSVERTIGOAGRANULOCYTOSISANAPHYLACTIC SHOCKANGIOEDEMABULLOUS ERUPTIONCONJUNCTIVITISDEATHDERMATITIS EXFOLIATIVEDIARRHOEADYSPNOEAECZEMAEOSINOPHILIAERYTHEMA

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Spontaneous Report of Adverse Drug Reaction 2004 31

ALLOPURINOL

ALMITRINE + RAUBASINE

- 5 5 - 10- 1 - - 1- - 1 - 1- 3 3 - 61 2 1 - 4- 4 1 - 51 1 1 - 3- - 1 - 1- - 1 - 1- 1 - - 1- 2 1 - 31 1 - - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1

- - 1 - 1- 1 - - 1

- 1 - - 12 10 5 - 17- 1 - - 13 19 14 - 361 11 5 1 18- 1 - - 14 21 11 1 37- - 1 - 1- 1 - - 1- 21 14 - 35

- 3 2 - 5- 1 - - 1- 2 - - 2- 4 2 - 6

- 2 2 - 4- 1 -- - 1- 2 - - 2-- - 1 - 1- 1 - - 1- - 4 - 4- - 1 - 1

ERYTHEMA MULTIFORMEEXUDATE NIPPLESFACE OEDEMAFEVERFIXED ERUPTIONHEPATITISHOT FLUSHESHYPERPIGMENTATION SKINMOUTH ULCERATIONMUCOSITIS NOSNAUSEANEUROPATHY PERIPHERALOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALORAL ULCERATIONPARALYSIS MUSCLE

LOCAL SKELETALPENILE SWELLINGPHOTOSENSITIVITY TOXIC

REACTIONPITYRIASIS ROSEAPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PURPURICRENAL FUNCTION ABNORMALSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS APHTHOUSSYNCOPETOXIC EPIDERMAL

NECROLYSISURTICARIAVASCULITISVOMITINGATAXIACHEILITISDIZZINESSINSOMNIA

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ALMITRINE + RAUBASINE

ALPRAZOLAM

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE +SIMETHICONE

ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +KAOLIN

ALUMINIUMHYDROXIDE + MAGNESIUMCARBONATE +SIMETHICONE+DIMETHYLPOLYSILOXANE+DICYCLOMINE (KREMIL- S)

AMBROXOL HYDROCHLORIDE

AMIDOTRIZOIC ACID + MEGLUMINE

AMIKACIN

- - 1 - 1- 2 1 - 3- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 2 - - 2- 3 1 - 4- 3 1 - 4- 1 1 - 2- - 1 - 1- 2 - - 2- 1 - - 11 - - - 1- 1 - - 11 - - - 1- 1 1 - 2- - 1 - 1-- - 1 - 1

-- - 1 - 1

- 1 - - 1- 1 - - 1-- - 1 - 1- 2 - - 2- 1 - - 1- 2 1 - 3- - 2 - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1

OEDEMA PERIORBITALPALPITATIONPARAESTHESIAANGIOEDEMADYSPNOEAFATIGUEFIXED ERUPTIONPALPITATIONPURPURARASH MACULO-PAPULARSWEATING INCREASEDSYNCOPETOXIC EPIDERMAL

NECROLYSISANGIOEDEMANAUSEAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGABDOMINAL PAINANGIOEDEMAFATIGUERASH ERYTHEMATOUSURTICARIAURTICARIA

RASH ERYTHEMATOUS

DIARRHOEANAUSEAOEDEMAPALPITATIONPRURITUSRASHRASH MACULO-PAPULARURTICARIAVOMITINGANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKPAPULAR RASHCHILLS

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Spontaneous Report of Adverse Drug Reaction 2004 33

AMIKACIN

AMINO ACIDS

AMINOPHYLLINE

AMINOSALICYLIC ACID

AMIODARONE

AMITRIPTYLINE

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1-- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1-- - 1 - 1- 1 - - 1- 1 - - 1- 2 2 - 4- 7 6 - 13- 4 5 - 9- 6 5 - 11- - 1 - 1- 1 - - 1- 1 - - 1- 2 3 - 5- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1-- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 3 - - 3- 1 2 - 3- - 2 - 2- 1 - - 1- -- 1 - 1- 2 - - 2- - 1 - 1-- - 1 - 1- 1 - - 11 1 - - 2- 1 - - 1- 1 - - 1- 1 - - 1

CONVULSIONSDERMATITIS EXFOLIATIVEDYSPNOEAECZEMAELECTROLYTE ABNORMALITYERYTHROMELALGIAFACE OEDEMAFAINTNESSFEVERFLUSHINGNEPHRITISNEPHROPATHY TOXICOEDEMAOTOTOXICITYPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTERENAL FUNCTION ABNORMALTREMORURTICARIAFLUSHINGHEADACHENAUSEAVOMITINGDERMATITIS EXFOLIATIVEDIZZINESSFIXED ERUPTIONHYPONATRAEMIANAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTASTE LOSSURTICARIAVOMITINGPETECHIAEPRURITUSARRHYTHMIAHYPOKALAEMIAQT PROLONGEDANGIOEDEMAARTHRALGIA

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AMITRIPTYLINE

AMLODIPINE

- 1 1 - 2- 1 - - 1- 1 - - 1- 3 5 - 8- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 2 - 4- 1 - - 1- - 1 - 1- - 1 - 1- 1 2 - 3- - 2 - 2- 1 - - 1- - 2 - 2- 1 2 - 3- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2

- 1 - - 1- - 1 - 1- 1 - - 1- 3 2 - 5- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 4 1 - 5- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- - 1 - 1- 4 3 - 7- 3 - - 3- - 1 - 1- 1 - - 1- - 1 - 1- - 4 1 5- 2 2 1 5- 1 1 - 2

CONFUSIONDROWSINESSDYSPNOEAFACE OEDEMAFATIGUEFIXED ERUPTIONHALLUCINATIONHEADACHEHEPATITISHYPONATRAEMIAMOUTH DRYOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHEALPARAESTHESIAPRURITUSRASHRASH PURPURICSEROTONIN SYNDROMESLEEP DISORDERSTEVENS JOHNSON

SYNDROMESTOMATITISTACHYCARDIATHIRSTURTICARIAVESICULAR ERUPTIONVISION ABNORMALABDOMINAL DISTRESSANGIOEDEMABRADYCARDIAFACE OEDEMAGINGIVAL HYPERTROPHYHYPERTENSIONMOUTH DRYOEDEMAOEDEMA DEPENDENTOEDEMA LEGSOEDEMA PERIPHERALPALPITATIONPARAESTHESIAPETECHIAEPRURITUSRASHRASH ERYTHEMATOUS

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Spontaneous Report of Adverse Drug Reaction 2004 35

AMLODIPINEAMMONIUM CARBONATE

AMMONIUM CARBONATE + GLYCYRRHIZA EXTRACT +IPECACUANHA

AMMONIUM CITRATE + GLYCYRRHIZAAMOBARBITAL

AMOXYCILLIN

- 1 - - 1- 1 - - 1- 1 1 - 2- 4 6 - 10- 1 - - 1

- 1 - - 1- - 1 - 1- - 1 - 1- 1 2 - 3- 1 - - 1- 1 - - 1- 2 1 - 3- 1 - - 1- 1 - - 11 16 2 - 195 17 8 - 30- 2 1 - 3- 12 3 - 151 - - - 1- 1 - - 14 44 18 - 66- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- - 1 - 12 10 7 - 191 4 1 - 6- 1 - - 1- 1 - - 1

1 3 2 - 6- 1 - - 11 10 5 - 16- 1 1 - 2- 2 - - 2- 1 2 - 31 - - - 1- 4 - - 4- 12 - - 12- 2 3 - 5- 1 - - 1- - 1 - 18 63 20 1 92

URTICARIAOEDEMARASHRASH ERYTHEMATOUSURTICARIA

MACULAR RASHPRURITUSRASHABDOMINAL PAINALLERGYALOPECIAANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGINAANGINAL PAINANGIOEDEMAANGIOMAAPNOEAARRHYTHMIAARTHRALGIAASTHMABRONCHOSPASMBULLOUS ERUPTIONBURNING SENSATIONCARPAL TUNNEL

SYNDROMECHEILITISCHEST ACHECHEST PAINCHILLSCONJUNCTIVITISDEATHDERMATITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDRY LIPSDYSPHONIADYSPNOEA

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AMOXYCILLIN - 2 - - 2- 1 - - 1- 1 - - 1- 4 1 - 52 10 2 - 14- 16 3 - 19- 1 - - 1- 1 - - 12 43 19 - 64- 1 - - 1- 5 1 - 6- 8 9 1 184 9 8 - 21- 1 - - 1- 2 - - 2- - 1 - 11 2 2 - 51 1 1 1 4- 1 - - 1- 1 - - 1- - 1 - 1

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 2 - 2

- 3 - - 3- 2 1 - 3- 2 - 1 3- 1 - - 1- - 1 - 1- - 1 - 1- 11 5 - 163 32 8 - 43- - 1 - 1- 4 2 - 61 1 - - 23 28 10 2 43- 1 1 - 2- - 3 - 31 25 19 - 451 2 2 - 5

ECZEMAECZEMA ATOPICEMACIATIONERUPTIONERYTHEMAERYTHEMA MULTIFORMEEXHAUSTIONEXTRAPYRAMIDAL DISORDERFACE OEDEMAFAINTNESSFATIGUEFEVERFIXED ERUPTIONFLATULENCEFLUSHINGGINGIVAL SWELLINGHEADACHEHOT DRY SKINHYPERPIGMENTATION SKINHYPOTENSIONINJECTION SITE

INFLAMMATIONINJECTION SITE PAINLABIAL ITCHINGLARYNGEAL OEDEMALYMPHADENITISMACULA LUTEA

ABNORMALITYMORBILLIFORM RASHMOUTH DRYMOUTH ULCERATIONMUCOSAL INFLAMMATIONMUCOSITIS NOSMYALGIANAUSEAOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA NOSOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERAL

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Spontaneous Report of Adverse Drug Reaction 2004 37

AMOXYCILLIN - 1 - - 1- 1 2 - 3- - 2 - 22 20 6 - 281 1 - - 2- 1 - - 1- 1 - - 1- 1 - - 11 - - - 113 209 104 4 330- 1 - - 1- 1 - - 1- 1 - - 118 282 153 4 457- 1 - - 19 162 93 3 267- 2 3 - 517 195 96 3 311- 1 3 - 4- 3 1 - 4- 3 - - 3- 1 - - 1- 1 - - 1- 1 1 - 21 - - - 1- 1 - - 1- 1 - - 11 1 - - 2- 1 1 - 22 25 8 1 36

- 12 6 - 18- 1 - - 1- 3 - - 3- - 1 - 1- 1 - - 1

1 1 1 - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 1 1 - 2

- 1 - - 1- 1 - - 1

OESOPHAGITISORAL ULCERATIONPAINPALPITATIONPARAESTHESIAPARAESTHESIA CIRCUMORALPETECHIAEPHOTOSENSITIVITY REACTIONPITYRIASIS ROSEAPRURITUSPSORIASISPURPURARALESRASHRASH ECCHYMOTICRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARRESPIRATORY DEPRESSIONRESPIRATORY DISORDERRESPIRATORY DISTRESSRIGORSSALIVA INCREASEDSCLERITISSHOCKSKIN REACTION LOCALISEDSPUTUM INCREASEDSTEVENS JOHNSON

SYNDROMESTOMATITISSUFFOCATION FEELINGSWEATING INCREASEDSWELLING AURICULARSWELLING

NON- INFLAMMATORYSYNCOPETHROAT DRYTHROMBOPHLEBITISTINNITUSTIREDNESSTONGUE DISORDERTOXIC EPIDERMAL

NECROLYSISTREMORURINARY RETENTION

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AMOXYCILLIN

AMOXYCILLIN + CLAVULANIC ACID

11 205 87 3 3061 1 - - 21 - 1 - 2- 1 - - 1- 4 2 - 6- - 1 - 1- 16 5 - 21- - 1 - 1- 1 - - 1- 4 - - 4- 1 - - 1- 1 1 - 21 - - - 1- 1 - - 1- 3 1 - 4- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 1 - 2- 6 5 - 111 4 - - 5- 6 4 - 10- - 2 - 2- - 1 - 1- 2 3 - 5- 3 - - 32 1 - - 3- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 7 6 - 13- 4 3 - 71 5 1 - 7- 3 1 - 41 - - - 1- - 4 - 41 22 21 1 453 36 29 - 68- 20 19 1 40- 1 1 - 2

URTICARIAURTICARIA ACUTEVASCULITISVERTIGOVESICULAR RASHVISION BLURREDVOMITINGWHEEZESWHEEZING EXPIRATORYABDOMINAL PAINALLERGIC CONJUNCTIVITISANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONCHEILITISCHEST PAINCOLITIS

PSEUDOMEMBRANOUSCONJUNCTIVITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONFLATULENCEFLUSHINGHEADACHEHEPATITISHOT DRY SKININSOMNIANAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPAIN BURNINGPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULAR

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Spontaneous Report of Adverse Drug Reaction 2004 39

AMOXYCILLIN + CLAVULANIC ACID

AMPHOTERICIN B(ANTIMYCOTICS FOR SYSTEMIC USE)

AMPHOTERICIN B (FOR INTESTINAL ANTIINFECTIVES)

AMPICILLIN

1 28 18 - 47- - 1 - 1

- 4 1 - 5- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 21 14 - 35- 1 - - 11 9 5 - 15- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

- - 1 - 1- 1 - - 1- 1 - - 13 4 1 - 8- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 11 - - - 1- 1 1 - 2- 1 - - 1- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 3 2 - 51 6 2 - 9- - 1 - 1- 2 - - 2- 7 3 - 10- 1 - - 1- 6 -- - 6

RASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS NECROTISINGSTOMATITIS ULCERATIVESTOOLS LOOSETINNITUSTONGUE DISORDERURTICARIAVERTIGOVOMITINGACIDOSISANAEMIAANAESTHESIA LOCALCHILLSCHOLESTASIS INTRAHEPATICCREATININE BLOOD

INCREASEDERYTHEMA MULTIFORMEFEVERHYPERBILIRUBINAEMIAHYPOKALAEMIAHYPOMAGNESAEMIANEPHRITISOEDEMA MOUTHOEDEMA PERIORBITALPANCYTOPENIAPHLEBITISRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL ACIDOSIS TUBULARRENAL FAILURE ACUTERENAL FAILURE CHRONICRENAL FUNCTION ABNORMALURTICARIAJAUNDICERASH ERYTHEMATOUSANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAARTHRALGIABRONCHOSPASM

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AMPICILLIN - 1 2 - 3- 1 1 - 2- 1 - 1 2- - 1 - 1- - 1 - 1- 13 8 1 22- 1 - - 11 1 - - 2- 3 - - 3- 7 2 - 9- 2 1 - 3- 4 - - 4- 3 1 - 4- 3 - - 3- 1 - - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 8 2 - 10- 1 - - 1- 3 1 - 4- 1 - - 1- 5 1 - 6- 1 - - 1- 2 2 - 4- 39 27 - 661 59 38 1 991 54 25 - 80- 58 25 - 84- - 1 - 1- - 1 - 1- - 1 - 1- - - 1 1- 1 - - 1- 2 - 1 3

- 1 - 1 2- 1 - - 1- 1 - - 1- - 1 - 13 58 18 3 82- 1 - - 1- 3 - - 3

CHEST PAINCHILLSCOUGHINGDIARRHOEADIZZINESSDYSPNOEAEPIPHORAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGHYPERPIGMENTATION SKINHYPERPYREXIAHYPOTENSIONJOINT PAINMORBILLIFORM RASHNEUTROPENIAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PETECHIALRESPIRATORY DEPRESSIONRESPIRATORY DISTRESSSCLERITISSHOCKSTEVENS JOHNSON

SYNDROMESTOMATITISSYNCOPETHROAT TIGHTNESSTRISMUSURTICARIAVAGINAL MYCOSISVOMITING

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Spontaneous Report of Adverse Drug Reaction 2004 41

AMPICILLIN

AMPICILLIN + SULBACTAM

AMPICILLIN FOR INJECTION

ANDROGRAPHIS PANICULATA

- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- 2 2 - 4- 1 1 - 2- 2 1 - 3- 1 - - 1- 2 1 - 3- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - 1 3- 1 1 - 21 10 5 - 161 - - - 1- 21 9 - 30- 1 - - 1- 12 6 - 18- 12 7 - 19- 1 - - 1- 1 - - 1- 1 - - 1- 16 5 - 21- 1 - - 1- -- 1 - 1

WHEALSWHEEZING EXPIRATORYANGIOEDEMAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICURTICARIAVESICULAR RASHANAESTHESIA MOUTHANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONDIARRHOEADYSPNOEAERYTHEMAERYTHEMA INDURATUMERYTHEMA MULTIFORMEEYE BURNSFACE OEDEMAFATIGUEFEVERHEPATITISHOT DRY SKINHYPERSENSITIVITYINJECTION SITE

INFLAMMATIONNAUSEANECK TIGHTNESSNOSE CONGESTIONOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSPURPURARASHRASH ACNEIFORMRASH ERYTHEMATOUSRASH MACULO-PAPULARRHINITISRIGORSTONGUE DISORDERURTICARIAVESICULAR RASHRASH

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ANGIOGRAFFINANGIOTENSIN II ANTAGONISTS, PLAIN

ANHYDROUS THYROXINE SODIUM

ANTACIDS

ANTAZOLINEANTAZOLINE HYDROCHLORIDEANTIRABIES EQUINE IMMUNOGLOBULIN (PASTEUR)ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)ARTESUNATEASPARAGINASE

ASPIRIN (ACETYLSALICYLIC ACID)

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1-- - 1 - 1- 1 2 - 3- 1 - - 1-- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1

- 2 1 - 3- 5 1 - 6- 8 1 1 101 4 1 - 63 30 5 - 381 5 1 - 7- 4 2 - 61 - - - 1- - 1 - 1- - - 1 1- 1 - - 1- 1 - - 1- 2 - - 2- 14 4 - 18- 1 - - 1- 1 - - 1- 1 - - 1- 11 5 - 6- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2

ANGIOEDEMAPRURITUSRASH ERYTHEMATOUSFACE OEDEMAFLUSHINGPRURITUSRASHRASH FOLLICULARANGIOEDEMARASHRASHOEDEMA PERIORBITALURTICARIAANAPHYLACTIC REACTIONURTICARIAANAPHYLACTIC SHOCKCEREBRAL INFARCTIONFEVERRASHRASH MACULO-PAPULARRIGORSTHROMBOSIS CEREBRAL

ARTERIALABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABRONCHOSPASMCHEST PAINCOAGULATION DISORDERCONJUNCTIVITISCOUGHINGDIARRHOEADIZZINESSDYSPEPSIADYSPNOEAENDOMETRIAL BLEEDINGEPISTAXISEYE IRRITATIONFACE OEDEMAFAINTNESSFATIGUEFEVERFIXED ERUPTION

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Spontaneous Report of Adverse Drug Reaction 2004 43

ASPIRIN (ACETYLSALICYLIC ACID)

ATAZANAVIR

ATENOLOL

- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 4 - - 4- 1 - - 1- 1 - - 1- 8 1 1 10- 22 6 - 28- 3 2 - 5- 1 - - 1

- 14 7 2 23- 15 5 - 20- 1 - - 1- 8 4 - 12- 2 1 - 3- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 11 1 - - 2- - 1 - 1- 1 1 - 2

1 12 2 1 17- - - 1 1- 1 1 - 2- - 1 - 11 - 2 - 3- - 1 - 1

FLATULENCEFLUSHINGGASPINGGASTRIC ULCER

HAEMORRHAGICGASTRITISGI HAEMORRHAGEHAEMATURIAHEPATITIS CHYPERKALAEMIAHYPERVENTILATIONMELAENANASAL CONGESTIONNEUROPATHYNEUTROPENIAOCULOGYRIC CRISISOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPHOTOSENSITIVITY ALLERGIC

REACTIONPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRESPIRATORY DISTRESSREYE'S SYNDROMERHABDOMYOLYSISSPASMSSTEVENS JOHNSON

SYNDROMESYNCOPETACHYCARDIATHIRSTTOXIC EPIDERMAL

NECROLYSISURTICARIAVASCULITISVOMITINGBILIRUBIN INCREASEDJAUNDICEANGIOEDEMA

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ATENOLOL

ATORVASTATIN

ATROPINE

ATROPINE SULFATE + DIPHENOXYLATEHYDROCHLORIDE

AZATHIOPRINE

- - 1 - 1- 4 2 - 6- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 1 - 2- 1 1 - 2- - 1 - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- - 2 - 2- 1 - - 1- - 3 - 3- 2 6 1 9- 1 1 - 2- - 1 - 1- 1 - - 1- 2 - - 2- - 1 - 1

- - - 1 1- 3 1 - 4- 1 1 - 2- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

ASTHMABRADYCARDIACHEST PAINDERMATITIS HERPETIFORMISDIARRHOEADIZZINESSDYSPNOEAECZEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFIX ERUPTIONHEADACHEHYPOTENSIONMOUTH DRYNAUSEAOEDEMAOEDEMA MOUTHPALPITATIONPERIPHERAL COLDNESSPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PUSTULARSINUS BRADYCARDIASTEVENS JOHNSON

SYNDROMESYNCOPEURTICARIAVOMITINGANGIOEDEMAFEVERMYALGIAOEDEMAPALPITATIONRASH MACULO-PAPULARRHABDOMYOLYSISURTICARIAMOUTH DRYRASH ERYTHEMATOUSPRURITUSRASH MACULO-PAPULARURTICARIAANAEMIADYSPNOEA

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Spontaneous Report of Adverse Drug Reaction 2004 45

AZATHIOPRINE

AZITHROMYCIN

BACAMPICILLIN

BACLOFEN

BAMBUTEROL

BELLADONNA ALKALOIDS, SEMISYNTHETIC,QUARTERNARY AMMONIUM COMPOUNDS

BELLADONNA TOTAL ALKALOIDSBELLADONNA TOTAL ALKALOIDS AND

PSYCHOLEPTICSBENZATROPINEBETAHISTINE

BETAMETHASONE

- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 6 - 7- 1 1 - 2- 3 1 - 4- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

- - 1 - 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1

- - 1 - 1- - 1 - 1

- - 1 - 1- - 1 - 1- - 1 - 1- 2 - - 2- - 1 1 2- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 1 - 2- - 1 - 1

ERYTHEMA MULTIFORMEINFECTIONPRURITUSRASHTHROMBOASTHENIAURTICARIADIARRHOEAERYTHEMA MULTIFORMEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVISION ABNORMALDYSPNOEAPRURITUSRASH ERYTHEMATOUSFACE OEDEMAGASTRIC ULCER

HAEMORRHAGICHYPOVOLAEMIAOEDEMAPRURITUSRASHCRAMPSCRAMPS LEGSPAPULAR RASHPRURITUSRASHSTEVENS JOHNSON

SYNDROMEFACE OEDEMAHEADACHE

PARKINSONISMDIZZINESSHEADACHENAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGFACE OEDEMARASH ERYTHEMATOUS

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BETHANECHOLBETHANECOL CHLORIDEBEZAFIBRATE

BICALUTAMIDEBISACODYL

BISACODYL+SODIUM CARBOXYMETHYLCELLULOSE+DIOCTYL SODIUM SULFOSUCCINATE

BISOPROLOL

BLEOMYCIN

BLOOD AND BLOOD FORMING ORGANSBLOOD AND RELATED PRODUCTSBLOOD TESTS, AUXILIARY PRODUCTSBLOOD TRANSFUSION, AUXILIARY PRODUCTSBROMAZEPAM

BROMHEXINE

- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 2 - - 2- 4 - - 4- 1 - - 1- 1 1 - 2- 1 - - 1

- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 11 - - - 11 - - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 1 - 3- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- 4 - - 4

RASHANGIOEDEMAHEPATITISRENAL FAILURE ACUTERHABDOMYOLYSISGYNAECOMASTIAHYPOKALAEMIARASH MACULO-PAPULARRASH MACULO-PAPULAR

HYPOTENSIONPALPITATIONPRURITUSPULSE WEAKRASHRASH ERYTHEMATOUSTONGUE DISORDERTORTICOLLISVERTIGODRUG FEVERPALPITATIONRASH ERYTHEMATOUSRASH MACULO-PAPULARRASHRASHRASH ERYTHEMATOUSHEADACHEINSOMNIAMUSCLE WEAKNESSNAUSEAPALPITATIONANAPHYLAXISANURIACHEILITISDIARRHOEADYSPNOEAERYTHEMA MULTIFORMEEYE PAINFEVERMACULAR RASHNYSTAGMUSOEDEMAOEDEMA PERIORBITALPAINPALPITATIONPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 47

BROMHEXINE

BROMPHENIRAMINE

BROMPHENIRAMINE + PSEUDOEPHREDRINEBUDESONIDE

BULK PRODUCERSBUPIVACAINE

BUPIVACAINE + DEXTROSE MONOHYDRATE

- 5 3 - 8- 1 3 - 4- 4 1 - 5- 1 - - 1- 1 - - 1

- 1 - - 11 3 - - 4- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1

- - 2 - 2- - 2 - 2- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 - 1 22 - 63 1 66- - 1 - 1- - 27 2 30- - - - 1- - - - 1- - 29 1 30- 4 - - 4

RASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMETACHYCARDIAURTICARIAVOMITINGANAPHYLAXISBLEPHARITISCHEST PAINPALPITATIONSYNCOPERASH ERYTHEMATOUSDYSPNOEAGLOSSITISHOARSENESSPALPITATIONRASHRASH ERYTHEMATOUSSYNCOPETONGUE INFLAMMATIONTONGUE PARALYSISTREMORVERTIGORASH ERYTHEMATOUSBLOOD PRESSURE

DROP ARTERIALBRADYCARDIACHILLSHYPOTENSIONMUSCLE WEAKNESSPRURITUSRASHSOMNOLENCESPASM GENERALIZEDUNCONSCIOUSNESSURTICARIABRADYCARDIABRADYPNOEACARDIAC ARRESTCHEST PAINDYSPNOEAEYE ABNORMALITYHEADACHE

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⌦48

BUPIVACAINE + DEXTROSE MONOHYDRATE

BUPROPION

CALAMINE LOTION

CALCITONIN (HUMAN SYNTHETIC)

CALCITONIN (SALMON SYNTHETIC)

CALCIUM CARBONATE

CALCIUM GLUCONATE

CALCIUM LACTATECANDESARTAN

CANDESARTAN + HYDROCHLOROTHIAZIDE

CAPECITABINE

CAPTOPRILCARBAMAZEPINE

- - 2 - 21 1 83 1 86- - 28 - 28- - 2 - 2- - 29 - 29- - 1 - 1- - 27 - 27- - - 1 1- - 28 - 28- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 21 2 - - 3- 1 - - 1

- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

HYPERTENSIONHYPOTENSIONMUSCLE RIGIDITYPULSE WEAKRESPIRATORY DEPRESSIONSPASM GENERALIZEDTONIC CONVULSIONTORTICOLLISUNCONSCIOUSNESSURTICARIAHEADACHEINSOMNIAMOUTH DRYRASH ERYTHEMATOUSFACE OEDEMARASHSKIN ULCERATIONCHEST PAINDYSPNOEAHYPERCALCAEMIAOEDEMA PERIORBITALFIXED ERUPTIONHYPERCALCAEMIAPRURITUSRASHSTEVENS JOHNSON

SYNDROMEVOMITINGCHILLSFEVERRASHDIZZINESSHYPOTENSIONCOUGHINGRASH ERYTHEMATOUSABRASION NOSCARPAL TUNNEL

SYNDROMEDERMATITISDIARRHOEANAUSEASTOMATITISVOMITINGRASH ERYTHEMATOUSABRASION NOSACNEIFORM DERMATITISAGRANULOCYTOSIS

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Spontaneous Report of Adverse Drug Reaction 2004 49

CARBAMAZEPINE - 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 11 - - - 1- - 1 - 1- 1 1 - 2- - 2 - 2- 3 2 - 5- 2 - - 2- - 2 - 2- 1 - - 1- - 1 - 1- 2 - - 2- 2 - - 2- 3 1 - 41 - - - 1- 3 2 - 5- 2 - - 2- 10 1 - 11- 1 - - 1

- - 1 - 1- 1 - - 1- 1 1 - 2- 4 2 - 6- 1 1 - 2- 1 1 - 2- 1 - - 1- 3 1 - 4- 1 - - 1- 1 - - 1- - 1 - 1- 2 - 1 3- 2 - - 2- - 1 - 1- 2 1 - 3- 2 1 - 3- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

AKINESIAALLERGIC CONJUNCTIVITISANAESTHESIA LOCALANAESTHESIA MOUTHANAESTHESIA TONGUEANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAASTHENIAATAXIABRONCHOSPASMBULLOUS ERUPTIONCHEILITISCHEST DISTRESSCONJUNCTIVITISDEATHDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAERYTHEMA MULTIFORMEERYTHEMA MULTIFORME

SEVEREERYTHRODERMAEYE IRRITATIONFACE OEDEMAFEVERFIXED ERUPTIONFLUSHINGGLOSSITISHEADACHEHEPATIC DAMAGEHEPATITISJAW STIFFNESSMOUTH ULCERATIONNAUSEAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALORAL ULCERATIONPAINPALPITATIONPANCYTOPENIAPAPILLOEDEMA

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⌦50

CARBAMAZEPINE

CARBIDOPA + LEVODOPA

CARBOCISTEINE

CARBOPLATIN

CARISOPRODOLCARISOPRODOL + PHENYLBUTAZONE

- 1 - - 1

- 7 4 - 112 13 6 1 22- 6 8 - 14- 1 - - 11 15 5 - 21- - 1 - 1- - 1 - 1- 1 - - 1- 1 1 - 25 36 11 - 52

- 3 - - 3- 1 - - 1- - 1 - 1- - 1 - 1- 4 2 - 6

1 2 2 - 5- 1 - - 1- - 1 - 1- 2 - - 2- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 1 - 21 - - - 11 1 1 - 3- 1 - - 1- 1 - - 1

PHOTOSENSITIVITY TOXICREACTION

PRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARSKIN EXFOLIATIONSKIN NECROSISSKIN ULCERATIONSPEECH DISORDERSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVESYNCOPETHROMBOCYTOPENIATOXIC EPIDERMAL

NECROLYSISURTICARIAVERTIGOVISION BLURREDVOMITINGWEAKNESS GENERALIZEDCHEILITISDERMATITISDIZZINESSFEVERPRURITUSRASHURTICARIACOUGHINGFACE OEDEMAFIXED ERUPTIONPRURITUSRASHURTICARIAVOMITINGANAPHYLACTIC SHOCKRASH MACULO-PAPULARRASH MACULO-PAPULARANGINAANGIOEDEMAARRHYTHMIADYSPNOEAFIXED ERUPTIONOEDEMA PERIORBITAL

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Spontaneous Report of Adverse Drug Reaction 2004 51

CARISOPRODOL + PHENYLBUTAZONE

CARVEDIOL

CASPOFUNGINCEFACLOR

CEFALEXIN

- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 2 - 3- 3 3 - 6- 2 3 - 5- - 3 - 3- 2 3 - 5- 1 - - 1- 1 - - 1- 1 - - 1- 2 3 - 5- 1 - - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 8 3 - 11- 1 - - 1- 1 2 - 3- 1 - - 1- 1 1 - 2- 1 - - 11 1 - - 2- 2 - - 2- - 1 - 1- 1 2 - 3- - 1 - 1

- - 1 - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 3 1 - 4- 1 1 - 21 - - - 1- 1 1 - 2

PRURITUSRASHSYNCOPEVASCULITISCHROMATOPSIAURTICARIAPRURITUSANGIOEDEMADYSPNOEAERYTHEMAFACE OEDEMAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABRONCHOSPASMCHEILITISDIARRHOEADIZZINESSDYSPNOEAEAR NOISESECZEMAERUPTIONERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONHEADACHELIPS SWELLING

NON-SPECIFICMORBILLIFORM RASHNAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALOEDEMA PHARYNXPALPITATION

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CEFALEXIN

CEFALORIDINECEFAMANDOLECEFAPIRINCEFATRIZINE

CEFAZOLIN

- 26 5 - 31- 19 16 2 37- 18 7 - 25- 1 - - 1- 18 7 - 25- 1 - - 1- 3 1 - 4

- 1 - - 1- 1 - - 1- 18 10 - 28- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 11 3 - - 4- 1 - - 1- - 1 - 1- 1 - - 1

- 3 - - 3- 1 - - 1- - 1 - 1- 8 3 - 11- 1 - - 1- 2 - - 2- - 1 - 1- 3 1 - 4- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 6 2 1 9- - 1 - 1- 3 - - 3- 2 2 - 4- - 1 - 1- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARSKIN COLD CLAMMYSTEVENS JOHNSON

SYNDROMESWELLING AURICULARSYNCOPEURTICARIAVERTIGORASHRASHRASHGINGIVAL SWELLINGHEADACHERASH ERYTHEMATOUSABDOMINAL PAINANAESTHESIA MOUTHANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABLOOD PRESSURE

DROP ARTERIALBRONCHOSPASMCHEST PAINDERMATITIS EXFOLIATIVEDYSPNOEAECZEMAERYTHEMA MULTIFORMEEXANTHEMAFACE OEDEMAFEVERFLUSHINGHEART FLUTTERINGHOT FLUSHESINJECTION SITE PAINJOINT PAINLABIAL ITCHINGNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATION

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Spontaneous Report of Adverse Drug Reaction 2004 53

CEFAZOLIN

CEFAZOLIN EYE DROPCEFDINIR

CEFDITOREN PIVOXIL

CEFEPIME

1 24 17 1 431 24 23 2 501 10 8 - 19- 1 - - 1- 18 7 2 27- - 1 - 11 - - - 1

- 1 - - 11 33 18 - 52- 6 2 1 9- 1 - - 1- 1 - - 1- 2 3 - 5- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1

- - 1 - 1- - 1 - 1- 2 2 - 4- 5 4 - 9- 3 5 - 81 4 5 - 10- - 1 - 1

- - 1 - 1

- 2 1 1 4- 1 - - 1- 1 - - 1- - 2 - 2- 1 2 - 3- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 2 - 4- 5 2 - 7- 4 1 - 5- - 1 - 1- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PUSTULARSTEVENS JOHNSON

SYNDROMESYNCOPEURTICARIAVOMITINGRASH ERYTHEMATOUSDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSERYTHEMAFAECES BLOODSTAINEDFEVERLIPS SWELLING

NON-SPECIFICNAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMETOXIC EPIDERMAL

NECROLYSISURTICARIAFACE OEDEMAOEDEMA PERIORBITALPRURITUSRASHRASH MACULO-PAPULARRASH PURPURICFIXED ERUPTIONMORBILLIFORM RASHNAUSEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSEIZURE ANOXICSTEVENS JOHNSON

SYNDROME

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CEFEPIMECEFIXIME

CEFODIZIME DISODIUMCEFOPERAZONE

CEFOPERAZONE + SULBACTAM (SULPERAZONE)

CEFOTAXIME SODIUM

- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 2 4 - 6- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 4 - - 4- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 4 3 - 7- 5 2 - 7- 3 5 - 8- 1 - - 1- 1 - - 1

- - 1 - 1- - 4 - 4- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- - - 2 2- 1 - - 1- - 1 - 1- 3 1 1 5- 1 - - 1

VOMITINGFACE OEDEMAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTOMATITISRASHANAESTHESIA MOUTHDIARRHOEADRUG ERUPTIONFACE OEDEMAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIABRONCHOSPASMDRUG FEVERFACE OEDEMAHAEMORRHAGE NOSJAUNDICELIVER FUNCTION TESTS

ABNORMAL NOSPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICSTEVENS JOHNSON

SYNDROMETHROMBOCYTOPENIAURTICARIAAGRANULOCYTOSISANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAARTHRALGIABRONCHOSPASMCONVULSIONS AGGRAVATEDDEATHDIZZINESSDYSPNOEAECZEMA

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Spontaneous Report of Adverse Drug Reaction 2004 55

CEFOTAXIME SODIUM

CEFOXITIN

- 1 - - 1- - 3 - 3- 1 1 - 2- 1 - - 1- 2 2 - 4- 2 1 - 3- - 1 - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 2 - - 2- 1 1 - 2- - 1 - 1- - 1 - 1

- - - 1 1- 17 10 - 271 26 20 - 47- 18 14 - 32- - 1 - 1- 38 27 1 66- - 1 - 1- 1 - - 1- 1 2 - 3

- 1 - - 1- 1 - - 1- - 1 - 1

- 17 10 1 28- 1 - - 1- 1 - - 1

- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 11 1 3 - 5- 8 3 - 11- - 1 - 11 4 4 - 9- 1 - - 1

EOSINOPHILIAERYTHEMA MULTIFORMEFACE OEDEMAFEARFEVERFIXED ERUPTIONFLUSHINGHEADACHENAUSEAOEDEMAOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPAPULAR RASHPARAESTHESIA

CIRCUMORALPNEUMONIAPRURITUSRASHRASH ERYTHEMATOUSRASH HAEMORRHAGICRASH MACULO-PAPULARRESPIRATORY DISORDERSPASM GENERALIZEDSTEVENS JOHNSON

SYNDROMESTOMATITISTHROMBOPHLEBITISTOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGANAPHYLACTIC

REACTIONANAPHYLAXISANGIOEDEMAFATIGUEHYPOTENSIONOEDEMAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSWEATING

INCREASED

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CEFOXITIN

CEFPIROME

CEFPROZIL

CEFTAZIDIME

CEFTIBUTEN

- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 2 1 - 3- 2 2 1 5- 1 3 - 4- 1 1 - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2

- 1 - - 1- 4 - - 4- - 1 - 1- - - 1 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - - 1 1- 5 5 - 102 13 7 - 22- 10 6 - 16- 13 12 1 26- - 2 - 2

- 2 - - 2

- 4 5 2 11- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- -- 1 - 1

URTICARIAVERTIGOVOMITINGANAPHYLACTIC REACTIONANAPHYLACTOID REACTIONANAPHYLAXISAPNOEABRONCHOSPASMDERMATITIS EXFOLIATIVEDYSPNOEAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAOEDEMA PERIORBITALRASHRASH MACULO-PAPULARANAPHYLACTIC

REACTIONCHILLSDYSPNOEAERYTHEMA MULTIFORMEFEVERFLUSHINGNEPHRITISOEDEMA MOUTHOEDEMA PERIORBITALPAPULAR RASHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FUNCTION

ABNORMALSTEVENS JOHNSON

SYNDROMEURTICARIAURTICARIA ACUTEANGIOEDEMAFACE OEDEMAOEDEMA PERIORBITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULAR

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Spontaneous Report of Adverse Drug Reaction 2004 57

CEFTIZOXIME

CEFTRIAXONE

- 1 - - 1- 1 1 - 2- 1 - - 1- 2 - - 2- 1 - - 1- 3 - - 3- 1 - - 1- 2 2 - 4- - 1 - 1- 2 1 - 3- 1 - - 1

- 2 - - 2- 1 1 - 2- 3 - - 3- 15 1 - 16

1 24 3 - 28- 1 1 - 2

2 8 3 - 13- 18 4 - 22- 2 1 - 3- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1

- 1 - - 11 8 5 - 141 5 3 - 91 4 1 1 7- 1 - - 1- 1 - - 1- - 1 - 1- 4 3 - 7- 1 - - 1- 6 1 - 74 34 8 - 46- - 1 - 1- 1 - - 1- - 1 - 1- - 2 - 2- 4 1 - 5- 1 2 1 4

DYSPNOEAERYTHEMAFEVEROEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAADAMS STOKES

SYNDROMEANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC

REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID

REACTIONANAPHYLAXISANGIOEDEMAAPNOEAARRHYTHMIAASPHYXIAASTHMABLOOD PRESSURE DROP

ARTERIALBRONCHORRHOEABRONCHOSPASMCHEST PAINCHILLSCOUGHINGCYANOSISDEATHDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAECZEMAEOSINOPHILIAEPILEPSYERUPTIONERYTHEMAERYTHEMA MULTIFORME

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CEFTRIAXONE - 1 - - 1

1 - - - 1- 1 - - 1- - 1 - 1

- 12 2 - 14- 2 - - 2- 1 - - 11 10 7 2 20- 4 5 - 9- 1 - - 1- 1 - - 1- 5 2 - 71 - - - 1- - 1 - 1

- 1 - - 1- 1 - - 1- 8 1 - 91 - 1 - 2

- 1 - - 1- - 1 - 1

- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 12 27 8 - 37- 1 - - 1- 2 - - 2- 8 4 - 12- 14 4 - 18- 15 1 - 16- - 1 - 1- 1 - - 1

- - 1 - 11 9 4 - 141 2 - - 3- 1 - - 1

ERYTHEMA MULTIFORMESEVERE

ERYTHRODERMAERYTHROMELALGIAEXTRAPYRAMIDAL

DISORDERFACE OEDEMAFAINTNESSFATIGUEFEVERFIXED ERUPTIONFIXED PUPILSFLATUSFLUSHINGHEADACHEHEPATIC ENZYMES

INCREASEDHYPERACTIVITYHYPERVENTILATIONHYPOTENSIONINJECTION SITE

PAINJOINT PAINMACULA LUTEA

ABNORMALITYMORBILLIFORM RASHMOUTH CYSTMOUTH DRYMUSCLE RIGIDITYMYALGIANASAL CONGESTIONNAUSEANUMBNESSNUMBNESS ORALOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA SCROTUMORAL ULCERATIONPAINPALPITATIONPARAESTHESIAPARAESTHESIA

CIRCUMORAL

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Spontaneous Report of Adverse Drug Reaction 2004 59

CEFTRIAXONE

CEFTRIAXONE DISODIUM

- 1 - - 1- 1 - - 16 116 53 - 175- 1 - - 1

- 1 - - 19 186 84 1 280- 89 52 - 1413 115 49 1 168- 1 - - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 2 - - 2

- 1 - - 1

- 1 - - 1

- 1 - - 11 3 - - 4

- - 1 - 1- 1 - - 1

- - 1 - 1

- 1 - - 1- 1 - - 1- 1 1 - 2

- 1 - - 1- - 1 - 14 120 41 1 1661 - - - 1- - 1 - 1- 1 - - 11 30 8 - 39- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1

PARAESTHESIA SKINPETECHIAEPRURITUSPRURITUS

AGGRAVATEDPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PETECHIALRASH PURPURICRASH PUSTULARRENAL FAILURE ACUTERESPIRATORY

DEPRESSIONRESPIRATORY RATE

INCREASEDSKIN REACTION

LOCALISEDSPASM GENERALIZEDSTEVENS JOHNSON

SYNDROMESWEATING INCREASEDSYNDROME OF INAPP

ADH SECRETIONTHERAPEUTIC RESPONSE

DECREASEDTHROAT SORETONGUE OEDEMATOXIC EPIDERMAL

NECROLYSISURINARY INCONTINENCEURINE ABNORMALURTICARIAVASOCONSTRICTIONVESICULAR RASHVIRILISMVOMITINGWHEALSANAESTHESIA LOCALANAPHYLACTIC REACTIONANAPHYLACTOID REACTIONBRONCHOSPASMCARDIAC ARREST

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CEFTRIAXONE DISODIUM

CEFTRIAXONE SODIUM

- 1 1 - 2- 2 - - 2- 1 - - 1- 1 1 - 2

- 1 - - 11 3 - - 4- 1 - - 11 4 2 - 7- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 1 - 2- - 1 - 1- 1 1 - 21 1 1 - 3- 1 - - 1- 1 - - 11 18 10 - 29- 20 12 - 32- 1 - - 12 12 2 - 16- 7 11 - 18- 1 - - 1- 1 - - 1- - 1 - 1

- 2 - - 21 2 - - 3- - 1 - 1- 9 7 - 16- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 11 - 1 - 2- - 1 - 1

CHEST PAINCHILLSCYANOSISDERMATITIS

EXFOLIATIVEDIZZINESSDYSPNOEAEYE ABNORMALITYFACE OEDEMAFIXED ERUPTIONFLUSHINGHOT DRY SKINHYPOTENSIONINJECTION SITE

REACTIONNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPAPULAR RASHPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARRHINITISRIGORSSTEVENS JOHNSON

SYNDROMESTOMATITISSYNCOPETREMORURTICARIAVOMITINGANAPHYLACTIC SHOCKCHEILITISCHILLSCONVULSIONSDEATHDIZZINESSERYTHEMA MULTIFORMEFACE OEDEMAFLUSHING

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Spontaneous Report of Adverse Drug Reaction 2004 61

CEFTRIAXONE SODIUM

CEFUROXIME

CELECOXIB

- 1 - - 1

1 - - - 11 6 4 - 12- 5 3 - 8- 5 3 - 8- - 6 - 7- 2 - - 2- 5 1 - 61 1 - - 2- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 5 - 5- 4 2 - 6- 5 2 - 7- 6 - - 6- 1 - - 1

- 3 - - 3- 1 - - 1- 1 1 - 2- 1 - - 1- 1 1 - 2

- - 1 - 1- - 1 - 1

- 5 1 - 6- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 2 - 4- 1 1 - 2- 3 1 - 4

- 1 - - 1

- 1 - - 1- - 1 - 1- 5 4 - 9- 2 - - 2

HEPATIC ENZYMESINCREASED

NAUSEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICURTICARIAVOMITINGABDOMINAL PAINANGIOEDEMAFACE OEDEMAOEDEMA MOUTHORAL ULCERATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSWELLING

NON-INFLAMMATORYURTICARIAVESICULAR RASHABDOMINAL PAINANAESTHESIA LOCALANAPHYLACTIC

REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID

REACTIONANGIOEDEMABLOATINGBRONCHOSPASMBULLOUS ERUPTIONDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAERYTHEMA

MULTIFORMEEXACERBATION OF

DISEASEEXANTHEMAEYE ABNORMALITYFACE OEDEMAFEVER

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CELECOXIB

CEPHALOSPORINS AND RELATE SUBSTANCES

CETIRIZINE

CETRIMIDE

CHLORAMBUCILCHLORAMPHENICOL

- 1 - - 11 1 - - 2- 1 1 - 2- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 11 11 6 - 18- 15 5 - 201 10 7 - 18- 1 3 - 4- - 1 - 1- - 2 - 2

- 2 - - 21 - - - 1- 1 - - 11 3 5 - 9- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 3 - - 3- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1

HEADACHEMOUTH DRYOEDEMAOEDEMA LEGSOEDEMA PERIORBITALOEDEMA PERIPHERALPAINPALPITATIONPARAESTHESIAPERIPHERAL ISCHAEMIAPOLYURIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSPASM GENERALIZEDSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVETHROAT SOREURTICARIAVOMITINGDIARRHOEAERYTHEMA MULTIFORMEFACE OEDEMAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARHEADACHEOEDEMA PERIPHERALPALPITATIONPRURITUSRASHSOMNOLENCEURTICARIAOEDEMA GENITALRASHRASHABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMADERMATITIS EXFOLIATIVE

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Spontaneous Report of Adverse Drug Reaction 2004 63

CHLORAMPHENICOL

CHLORAMPHENICOL FOR OPHTHAL

CHLORCYCLIZINE

CHLORDIAZEPOXIDE

CHLOROQUINE

- 1 - - 1

- 2 1 - 3

- 1 - - 1

- - 1 - 1

1 - - - 1

- 1 1 - 2

- 1 - - 1

- 3 - 1 4

- 3 2 - 5

- 1 - - 1

- 6 6 - 12

- 1 - - 1

1 12 7 - 20

- 6 3 1 10

- 1 5 1 14

- - - 1 1

- 1 - - 1

- 5 3 1 9

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 3 1 - 4

- - 2 - 2

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 - - 2

- 1 - - 1

- 2 - - 2

- - 1 - 1

- 2 - - 2

- 1 - - 1

- 1 - - 1

- - 2 - 2

- 3 1 - 4

DIARRHOEA

DYSPNOEA

ERYTHEMA MULTIFORME

FACE OEDEMA

FEVER

FIXED ERUPTION

NAUSEA

OEDEMA

OEDEMA PERIORBITAL

PHARYNGITIS

PRURITUS

PURULENT DISCHARGE

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

RASH PURPURIC

STEVENS JOHNSON

SYNDROME

URTICARIA

VOMITING

ANAPHYLAXIS

EPIPHORA

FACE OEDEMA

OEDEMA PERIORBITAL

PRURITUS

RASH

EXTRAPYRAMIDAL

DISORDER

DERMATITIS CONTACT

DRY LIPS

FACE OEDEMA

PHOTOSENSITIVITY

ALLERGIC REACTION

RASH

URINARY RETENTION

CHEST PAIN

DIZZINESS

DYSPNOEA

NAUSEA

OEDEMA

PALPITATION

PRURITUS

RASH

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CHLOROQUINE

CHLOROTHIAZIDE

CHLORPHENESIN FOR TOPICAL

CHLORPHENIRAMINE

- 2 - - 2

- 1 - - 1

- - 2 - 2

- - 1 - 1

- - 1 - 1

- 1 1 - 2

- 2 - - 2

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 - - 2

- 1 - - 1

- 2 1 - 3

- 6 1 - 7

- 1 - - 1

- 1 - - 1

- 2 - - 2

- 1 - 1 2

- 4 - - 4

- 1 - - 1

- 1 - - 1

- 1 1 - 2

- 1 - - 1

- 5 2 1 8

- 1 - - 1

- 6 3 - 9

- - - 1 1

- 3 1 - 4

- - 1 - 1

- 2 - - 2

- 1 - - 1

- 2 - - 2

- 2 - - 2

- - 1 - 1

RASH ERYTHEMATOUS

RASH PUSTULAR

STEVENS JOHNSON

SYNDROME

TINNITUS

URTICARIA

VISION ABNORMAL

VOMITING

ABDOMINAL PAIN

NAUSEA

VOMITING

FIXED ERUPTION

OEDEMA

AKATHISIA

ANAESTHESIA MOUTH

ANGIOEDEMA

DIZZINESS

DROWSINESS

DYSPNOEA

FACE OEDEMA

HEADACHE

HYPERVENTILATION

HYPOTENSION

ORTHOSTATIC

MOUTH DRY

NAUSEA

NUMBNESS

OEDEMA LEGS

OEDEMA PERIORBITAL

PALPITATION

PRURITUS

PYREXIA

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

RESPIRATORY

DEPRESSION

STEVENS JOHNSON

SYNDROME

SYNCOPE

TACHYCARDIA

TINNITUS

TONGUE OEDEMA

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Spontaneous Report of Adverse Drug Reaction 2004 65

CHLORPHENIRAMINE

CHLORPHENIRAMINE + ACETYLSALICYLIC ACID

CHLORPHENIRAMINE + ACETYLSALICYLIC ACID +PHENYLEPHRINE + CAFFEINE

CHLORPHENIRAMINE + AMMONIUM CHLORIDE +SODIUM CITRATE

CHLORPHENIRAMINE + PARACETAMOL +PHENYLEPHRINE

CHLORPHENIRAMINE + PSEUDOEPHEDRINECHLORPHENIRAMINE, COMBINATIONSCHLORPHENIRAMINE + DEXTROMETHORPHAN +

PHENYLPROPANOLAMINE+PARACETAMOL +SODIUM CITRATE

CHLORPROMAZINE

- 1 - - 1- - 4 - 4- 3 - - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1

- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 4 - - 4- - 1 - 1- - 1 - 1

-- 2 - - 2- 1 - - 1- - 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 9 - - 9- 2 1 - 3

- 1 - - 1- 1 - - 1- - - 1 1- 1 - - 1- 1 1 - 2

UNCONSCIOUSNESSURTICARIAVOMITINGANAPHYLACTIC SHOCKANGIOEDEMARASH MACULO-PAPULARURTICARIAOEDEMAOEDEMA PERIORBITALPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIA

ANAPHYLACTIC SHOCKFACE OEDEMARASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEPAPULAR RASHRASH ERYTHEMATOUSOEDEMA PERIORBITALRASH

AKATHISIAANGIOEDEMAANTICHOLINERGIC

SYNDROMEBRUISECONSTIPATIONDIZZINESSDROWSINESSDRUG ERUPTIONDYSARTHRIADYSPHAGIADYSTONIAEXTRAPYRAMIDAL

DISORDERFACE OEDEMAFESTINATING GAITFEVERHYPERPROLACTINAEMIAHYPOTENSION

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CHLORPROMAZINE

CHLORPROMAZINE + AMOBARBITAL

CHLORPROPAMIDE

CHLORTETRACYCLINE

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- - - 1 1- - 1 - 1- - - 1 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1

- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 2 - 2- 1 1 - 2- - 1 - 1- 1 - - 1

HYPOTENSION POSTURALJAUNDICEOCULOGYRIC CRISISPAINPALPITATIONPARAESTHESIAPENIS DISORDERPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSALIVA INCREASEDSEDATIONSLEEP DISORDERSPASM TONGUESTEVENS JOHNSON

SYNDROMETONGUE PARALYSISTREMORUNCONSCIOUSNESSVISION BLURREDVOMITINGDYSTONIAGALACTORRHOEAPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARFATIGUEFLUSHINGHYPERLIPAEMIAHYPOKALAEMIAOEDEMA LEGSPHOTOSENSITIVITY

ALLERGIC REACTIONRASH ERYTHEMATOUSBRONCHOSPASMBULLOUS ERUPTIONDYSPNOEAECZEMAFIXED ERUPTIONPRURITUSRASHRASH ACNEIFORMRASH ERYTHEMATOUS

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Spontaneous Report of Adverse Drug Reaction 2004 67

CHLORTETRACYCLINE

CHLORTETRACYCLINE HYDROCHLORIDE

CHLORZOXAZONECHLORZOXAZONE + PARACETAMOL

CHOLERA VACCINESCHOLESTYRAMINE

CHORIONIC GONADOTROPHIN

CILOSTAZOL

CIMETIDINE

- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 21 - - - 11 1 - - 2- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- 3 3 - 6- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 11 - 1 - 2- 1 - - 1- 1 - - 1

URTICARIAURTICARIA ACUTEDYSPNOEAOEDEMA MOUTHOEDEMA PERIORBITALANGIOEDEMAANGIOEDEMADYSPNOEARASHOEDEMACONSTIPATIONDYSPNOEAFACE OEDEMAFLATULENCEPRURITUSRASH ERYTHEMATOUSDIZZINESSHEADACHEOEDEMAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSAGRANULOCYTOSISANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAARTHRALGIABRONCHOSPASMCHILLSCONFUSIONDIZZINESSDYSPHONIADYSPNOEAFEVERFIXED ERUPTIONHEADACHEHYPOTENSIONINJECTION SITE PAINMYALGIANAUSEANEUTROPENIAOEDEMAPALPITATIONPERIPHERAL ISCHAEMIA

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CIMETIDINE

CIMETIDINE FOR INJECTION

CINNARIZINE

CIPROFLOXACIN

- 1 - - 1- 3 6 - 91 5 9 - 15- 3 - - 3- 2 1 - 3- - 1 - 1- - 1 - 1

- 1 - - 12 11 3 - 16- 1 1 - 2- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- 1 2 - 3- 1 4 - 5- 1 2 - 3- - 3 - 3- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 2 - 5- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 2 - 2

PETECHIAEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY DISORDERSTEVENS JOHNSON

SYNDROMETACHYCARDIAURTICARIAVOMITINGBRONCHOSPASMDYSPNOEAPRURITUSRASHURTICARIAVOMITINGANAPHYLACTIC REACTIONCHEST PAINDIZZINESSDRUG ERUPTIONDYSPNOEAFACE OEDEMAMOUTH DRYOEDEMAPARAESTHESIA SKINPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVERTIGOWHEEZESABDOMINAL PAINANAESTHESIA LIPANAESTHESIA LOCALANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAARTHRITISBLISTERSBRONCHOSPASMCHEST PAINCONFUSIONDERMATITIS EXFOLIATIVE

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Spontaneous Report of Adverse Drug Reaction 2004 69

CIPROFLOXACIN

CISAPRIDE

CISPLATIN

- - 1 - 1- - 2 - 2- 2 - - 2- - 1 - 1- 5 2 - 7- - 1 - 1

- - 1 - 1- 2 3 - 5- 5 1 - 6- - 1 - 1- 1 - - 1- - 1 - 1

- 1 - - 1- 1 1 - 2- 1 6 - 7- - 3 - 3- - 1 - 1- 2 3 - 5- 1 5 - 6- 1 - - 1- 1 2 - 3- 1 - - 1- 26 16 - 42- - 1 - 1- 39 35 - 741 19 14 - 34- 21 8 - 29- - 1 - 1- 3 1 - 4

- 1 3 - 4- 1 - - 1- 17 5 - 221 - - - 1- - 5 - 7- 1 - - 1- 1 1 - 2- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

DIARRHOEADIZZINESSDRUG ERUPTIONDYSPHONIADYSPNOEAEIGHTH NERVE

LESION NOSERYTHEMAFACE OEDEMAFIXED ERUPTIONGLOSSITISHOT DRY SKININJECTION SITE

BRUISINGLARYNGEAL OEDEMAMOUTH ULCERATIONNAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALPAINPALPITATIONPARAESTHESIAPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PUSTULARSTEVENS JOHNSON

SYNDROMESTOMATITISSWEATING INCREASEDURTICARIAVERTIGOVOMITINGDYSPNOEAPALPITATIONPAIN OF CHEST

BURNINGSWEATING INCREASEDANAPHYLACTIC REACTIONNAUSEANEUTROPENIAPRURITUSRASH

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⌦70

CISPLATINCITALOPRAM

CITRIC ACIDCLARITHROMYCIN

CLIDINIUM BROMIDE + CHLORDIAZEPOXIDECLIDINIUM+CHLORDIAZEPOXIDE

CLINDAMYCIN

- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 3 - 5- 5 1 - 6- 1 2 - 3- - 1 - 1- 1 - - 1

- - 1 - 1- 2 1 - 3- 1 2 - 3- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 2 - 4- - 1 - 1- 1 - - 1- - 1 - 1- 2 - - 2- 2 1 - 3

VOMITINGAGITATIONVERTIGONAUSEAPALPITATIONRASHBRONCHOSPASMCHEST PAINDIARRHOEADIZZINESSDYSPNOEAERYTHEMAFACE OEDEMAFEVERHEADACHENAUSEAOEDEMA GENERALISEDPAPULAR RASHPARALYSIS FACIALPRURITUSRASHRASH ERYTHEMATOUSSKIN EXFOLIATIONTOXIC EPIDERMAL

NECROLYSISTREMORURTICARIAVOMITINGURINARY RETENTIONANGIOEDEMAARTHRALGIADIZZINESSDYSPNOEAHEADACHEMYALGIANAUSEAPRURITUSRASH ERYTHEMATOUSTACHYCARDIAURTICARIAVOMITINGANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONCHILLSDERMATITIS EXFOLIATIVEDIARRHOEA

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Spontaneous Report of Adverse Drug Reaction 2004 71

CLINDAMYCIN

CLINDAMYCIN FOR INJECTION

CLOBAZAM

CLOMETHIAZOLECLOMIPRAMINE

CLONAZEPAM

- - 3 - 3- 4 2 - 6- - 1 - 1- 1 2 - 3- - 1 - 1- 2 3 - 5- 1 1 - 2- 3 3 - 6- 4 - - 4- 2 1 - 3- 1 - - 11 17 14 - 32- 14 13 1 281 5 15 1 22- 21 19 - 40- - 1 - 1- 7 7 1 15- 3 2 - 5- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 2 1 - 3- 1 3 - 4- 1 - 1 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1

- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 3 - 3- - 1 - 1- 1 - - 1- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1

DIZZINESSDYSPNOEAERUPTIONERYTHEMA MULTIFORMEEYE PAINFACE OEDEMAFEVERNAUSEAOEDEMA MOUTHOEDEMA PERIORBITALPHOTOSENSITIVITY REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTOMATITISURTICARIAVOMITINGANAPHYLACTOID REACTIONBRONCHOSPASMCHILLSDIARRHOEADYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIADIZZINESSFACE OEDEMAHEADACHERASHRASHANTICHOLINERGIC

SYNDROMEDIZZINESSHEADACHENAUSEAVOMITINGANGIOEDEMADIZZINESSDROWSINESSDYSPNOEANAUSEAPALPITATIONRASH ERYTHEMATOUSRASH MACULO-PAPULAR

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CLONAZEPAM

CLOPIDOGREL

CLORAZEPATE DIPOTASSIUM

CLOTRIMAZOLE

CLOTRIMAZOLE FOR TOPICAL

- - 1 - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1

- 1 2 - 3- 1 4 - 5- 1 1 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

1 -- - - 11 2 - - 3- 3 - - 3- 1 1 - 2

- 1 - - 1- 1 - - 1

SOMNOLENCEURTICARIAVOMITINGDIARRHOEADYSPNOEAENDOMETRIAL BLEEDINGFEVEROEDEMA PERIORBITALPROTHROMBIN TIME

PROLONGEDPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICSPASM GENERALIZEDTHROMBOCYTHAEMIATHROMBOCYTOPENIAURTICARIAANGIOEDEMADIZZINESSDYSPNOEAIRRITABILITYNAUSEARASH ERYTHEMATOUSURTICARIAANGIOEDEMABRONCHOSPASMDYSPNOEAERYTHEMAFACE OEDEMAFEVERFIXED ERUPTIONHYPERPIGMENTATION SKINMACULAR RASHOEDEMA GENERALISEDOEDEMA MOUTHPAPULAR RASHPR INTERVAL

PROLONGEDPRURITUSRASHRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMESTOMATITISPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 73

CLOTRIMAZOLE FOR TOPICAL

CLOXACILLIN

- 1 - - 1

1 3 1 - 5

- 1 - - 1

- - 1 - 1

- 1 - - 1

1 7 - - 8

4 11 2 - 17

- 1 - - 1

2 7 2 - 11

2 14 5 - 21

- - 1 - 1

- 1 - - 1

1 8 3 - 12

- 1 1 - 2

- 6 2 - 8

- 3 - - 3

- 1 1 - 2

- - 2 - 2

- 3 1 - 4

- 2 4 - 6

- - 1 - 1

1 28 10 1 40

- 1 - 1 2

1 - - - 1

- 2 1 - 3

- 4 1 - 5

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 14 10 1 25

- 9 3 1 13

- 5 3 - 8

- 1 1 - 2

- 1 - - 1

- - 1 - 1

- - - 1 1

- - 1 - 1

- - 1 - 1

- 2 - - 2

- - 1 - 1

1 - 2 - 3

RASH

ABDOMINAL PAIN

ALLERGY

ANAESTHESIA MOUTH

ANAESTHESIA TONGUE

ANAPHYLACTIC REACTION

ANAPHYLACTIC SHOCK

ANAPHYLACTOID REACTION

ANAPHYLAXIS

ANGIOEDEMA

ASTHENIA

ASTHMA

BRONCHOSPASM

BULLOUS ERUPTION

CHEST PAIN

CHILLS

DEATH

DERMATITIS EXFOLIATIVE

DIARRHOEA

DIZZINESS

DYSPHONIA

DYSPNOEA

ECZEMA

ERUCTATION

ERYTHEMA

ERYTHEMA MULTIFORME

ERYTHROMELALGIA

EXANTHEMA

EYE PAIN

FACE OEDEMA

FEVER

FIXED ERUPTION

FLUSHING

GENITAL ERUPTION

MALE

GINGIVITIS

GLOSSITIS

HAEMATOPOIESIS

DECREASED

HEADACHE

HYPERSENSITIVITY

HYPERVENTILATION

HYPOTENSION

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CLOXACILLIN - 1 - - 1

- 1 - - 1

- 4 1 - 5

- 1 1 - 2

- 3 - - 3

- 1 - - 1

2 8 4 - 14

1 6 4 - 11

- - 1 - 1

- 2 - - 2

- 1 - - 1

1 1 2 - 4

- 11 2 1 14

- 14 5 - 19

- 1 - - 1

- - 1 - 1

- 8 3 - 11

- - 1 - 1

- 2 - - 2

3 95 69 4 171

- 1 - - 1

7 132 93 3 235

- 1 - - 1

3 77 55 2 137

- 3 - - 3

5 84 53 2 144

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 - - 2

- 1 - - 1

- 1 2 - 3

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 1 - 3

- - 1 - 1

- 1 - - 1

7 86 43 2 138

- 1 - - 1

- 1 2 - 3

HYPOTHYROIDISM

JAW PAIN

MACULAR RASH

MOUTH DRY

MOUTH ULCERATION

MYALGIA

NAUSEA

OEDEMA

OEDEMA DEPENDENT

OEDEMA GENERALISED

OEDEMA GENITAL

OEDEMA LEGS

OEDEMA MOUTH

OEDEMA PERIORBITAL

ORAL DRYNESS

PAIN BURNING

PALPITATION

PARAESTHESIA

PHLEBITIS

PRURITUS

PURPURA

RASH

RASH BULLOUS

RASH ERYTHEMATOUS

RASH FOLLICULAR

RASH MACULO-PAPULAR

RASH PUSTULAR

RENAL FAILURE ACUTE

RESPIRATORY DEPRESSION

SKIN REACTION LOCALISED

STEVENS JOHNSON

SYNDROME

STOMATITIS

SYNCOPE

TACHYCARDIA

THROAT TIGHTNESS

THROMBOPHLEBITIS

TINNITUS

TONGUE PARALYSIS

TREMOR

URTICARIA

VASCULITIS

VESICULAR RASH

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Spontaneous Report of Adverse Drug Reaction 2004 75

CLOXACILLIN

CLOXACILLIN FOR INJECTION

CLOZAPINE

- 1 - - 11 7 3 - 11- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 6 - - 6- 1 - - 1- 1 - - 1- 2 1 - 3- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 1 - 2- 1 - - 1- 1 - 1 2- 1 - - 1- 11 5 1 171 16 11 - 28- 14 1 - 15- 16 5 - 21- 1 - - 1- 2 - - 2

- - 1 - 1- 17 4 - 21- 1 - - 1- - - 1 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 2 - - 2- 2 - - 2- 1 - - 1- 1 1 - 2

VISION ABNORMALVOMITINGWEAKNESS GENERALIZEDWHEEZING EXPIRATORYABDOMINAL PAINANAESTHESIA LOCALANAPHYLACTIC SHOCKANGIOEDEMABRONCHOSPASMDERMATITIS EXFOLIATIVEDYSPNOEAEOSINOPHILIAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERHEADACHEHEPATITISHYPERSENSITIVITYHYPOTENSIONINJECTION SITE

REACTIONOEDEMAOEDEMA MOUTHOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRIGORSSTEVENS JOHNSON

SYNDROMETHROMBOPHLEBITISURTICARIAVAGINAL HAEMORRHAGEVESICULAR RASHAKATHISIAAPNOEAASTHENIAATAXIACONFUSIONCONVULSIONSDIZZINESSDYSPHAGIA

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CLOZAPINE

CODEINE

CODEINE + BROMPHENIRAMINE + PSEUDOEPHREDINE

CODEINE + PHENYLTOXAMINE

CODEINE PHOSPHATE + GUAIFENESIN

CODEINE PHOSPHATE + GUAIFENESIN +TERPINE HYDRATE

CO-DERGOCRINE MESYLATE

COLCHICINE

- - 2 - 2- 1 - - 1- - 1 - 1

- - 1 - 1

- 2 - - 2- 1 - - 1- - 1 - 1- 2 - - 2- 1 1 - 2- 1 - - 1- 1 - - 1

- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 2 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 1 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1

DYSTONIAENURESISEXTRAPYRAMIDAL

DISORDERHEAD-FACE-NECK

SYNDROMEHYPERSALIVATIONHYPOTENSIONIRRITABILITYOCULOGYRIC CRISISSALIVA INCREASEDSYNCOPETONIC/ CLONIC

CONVULSIONSWEAKNESS GENERALIZEDDIARRHOEAOEDEMAPALPITATIONRASHRASH ERYTHEMATOUSPRURITUSRASH ERYTHEMATOUSPRURITUSRASHRASH MACULO-PAPULARANAPHYLAXISFACE OEDEMAOEDEMA MOUTHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTONGUE PARALYSISFACE OEDEMARASHANAPHYLACTIC SHOCKDYSPNOEAEXTRAPYRAMIDAL DISORDERMOUTH DRYNAUSEAPRURITUSVOMITINGABDOMINAL PAINANGIOEDEMACHEILITIS

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Spontaneous Report of Adverse Drug Reaction 2004 77

COLCHICINE

COLISTIN

CONJUGATED ESTROGEN

CONTRAST MEDIA

-- - 1 - 1- 3 4 - 7- - 1 - 1- - 2 - 2- 2 1 - 3- - 1 - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 2 1 - 3- 2 2 - 4- 4 1 - 5- - 4 - 4- - 5 - 5

- 1 - - 1- - 1 - 1

- 3 2 - 5- 1 2 - 3- - 1 - 1- - 2 - 2- 1 1 - 2- - 2 - 2- - 2 - 2- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 3 1 - 4- 2 1 - 3- 2 - - 2- 1 - - 1- 2 - - 2- 1 - - 1

DEATHDIARRHOEADIARRHOEA BLOODYDIZZINESSDYSPNOEAFEVERMORBILLIFORM RASHNAUSEAORAL ULCERATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESYNCOPETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGOEDEMA PERIORBITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARDIZZINESSNAUSEARASHRASH MACULO-PAPULARTOXIC EPIDERMAL

NECROLYSISURTICARIAANGIOEDEMABLOOD PRESSURE DROP

ARTERIALBRONCHOSPASMCHILLSCOUGHINGDYSPNOEAOEDEMAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAWHEEZES

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CURCUMA LONGA LINN.

CURCUMA XANTHORRHIZA ROXB. CYANOCOBALAMINCYCLOPHOSPHAMIDE

CYCLOSPORINE

CYPROHEPTADINE

CYPROTERONE ACETATE + ETHINYLESTRADIOL

CYTARABINE

DANAZOL

DAPSONE

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 11 1 - - 2

- 1 - - 1- 1 - - 1- - - 1 1- - - 1 1- - - 1 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 3 - - 3- 2 - - 2- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 2 - - 2- 2 - - 2- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1

- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

PRURITUSRASHFACE OEDEMARASH MACULO-PAPULARBONE MARROW

DEPRESSIONNAUSEARASH MACULO-PAPULARSKIN EXFOLIATIONSTOMATITISURTICARIAVOMITINGHEPATITIS CHOLESTATICHYPERTENSIONLYMPHOPENIARENAL FAILURE ACUTEANGIOEDEMADERMATITISFIXED ERUPTIONOEDEMA MOUTHPALPITATIONRASHRASH ERYTHEMATOUSDIZZINESSHEADACHEPRURITUSRASHDYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARDEATHHEPATIC FUNCTION

ABNORMALPRURITUSRASHRASH ERYTHEMATOUSSEPSISSTEVENS JOHNSON

SYNDROMEANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMABULLOUS ERUPTION

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Spontaneous Report of Adverse Drug Reaction 2004 79

DAPSONE

DEQUALINIUM

DESFLURANEDESOGESTREL

DEXAMETHASONE

- 1 - - 1- 1 - - 11 2 2 - 5- 1 - - 1- 1 - - 1- 2 2 - 4- 1 2 - 3- 1 1 - 2- 3 1 - 4- 1 - - 1

- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 11 1 - - 21 - - - 1- - 1 - 1- - 1 - 1

- 2 1 - 3- 7 2 - 9- 6 3 - 91 6 - - 7- 1 - - 1- 2 1 - 3

- 1 - - 1- - 1 - 1

- 1 1 - 21 - - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1

CHEST PIANCOUGHINGDERMATITIS EXFOLIATIVEDYSPNOEAERUPTIONERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERHEPATIC ENZYMES

INCREASEDHOT FLUSHESHYPERPYREXIAHYPERSENSATION SKINLYMPHADENOPATHYMORBILLIFORM RASHMYALGIANAUSEAPELLAGRAPHOTOSENSITIVITY

ALLERGIC REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH SCALYSTEVENS JOHNSON

SYNDROMESTOMATITISTOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGDYSPNOEAPRURITUSRASHSINUS BRADYCARDIAPRURITUSRASH MACULO-PAPULARACNEIFORM DERMATITISADRENAL CORTICAL

INSUFFICIENCYADRENAL CRISISADRENAL INSUFFICIENCYAGITATIONANAPHYLACTIC REACTIONANGIOEDEMA

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DEXAMETHASONE

DEXAMETHASONE + FRAMYCETIN + GRAMICIDINFOR OPHTHAL.& OTOLOGICAL

DEXAMETHASONE + NEOMYCIN FOROPHTHAL.& OTOLOGICAL

DEXTROMETHORPHAN

- - 1 - 1- 1 1 - 2- 1 - - 1- - 2 - 2- 1 - - 1- 1 2 - 3- - 1 - 1- 1 - - 1- 1 1 - 2- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 11 1 2 - 4- - 2 - 2- - 1 - 1- 3 - - 3- - 1 - 1

- 2 - - 2- 1 - - 11 - - - 1- - - 1 1- 1 - - 11 - - - 11 - - - 1- 1 - - 1- 2 1 - 3- 1 - - 1- - 1 - 1- 2 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 3 1 - 4- - 1 - 1

ARTHRALGIABRONCHOSPASMCELLULITISCONVULSIONSDIARRHOEADIZZINESSDYSPNOEAECCHYMOSISFACE OEDEMAFIXED ERUPTIONFLUSHINGGASPINGHEPATITISHYPERACTIVITYHYPERSENSITIVITYHYPOTHERMIAINFECTIONOEDEMAOEDEMA OF EXTREMITIESOEDEMA PERIORBITALPALPITATIONPRURITUSRASH ACNEIFORMRASH ERYTHEMATOUSRASH MACULO-PAPULARREFLEX PLANTAR

EXTENSORURTICARIAVISION ABNORMALVOMITINGCONJUNCTIVITIS AGGRAVATEDPERIORBITAL OEDEMACONJUNCTIVITISRASH ERYTHEMATOUSANAPHYLACTIC REACTIONANGIOEDEMACHEST PAINDIZZINESSDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSPURPURA

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Spontaneous Report of Adverse Drug Reaction 2004 81

DEXTROMETHORPHAN

DEXTROMETHORPHAN + BROMPHENIRAMINE +GUAIFENESIN + TERPIN HYDRATE

DEXTROMETHORPHAN + CHLORPHENIRAMINE +GLYCERYL GUIACOLATE

DEXTROMETHORPHAN + CHORPHENIRAMINE +METHYLEPHEDRINE

DEXTROMETHORPHAN + GUAIFENESIN +PSEUDOEPHEDRINE + DIPHENHYDRAMINE

DEXTROMETHORPHAN + GUAIFENESIN +TERPIN HYDRATE

DEXTROSE IN NORMAL SALINE ( 5 % )

DIASGESTDIASTASTE+EXTRACT NUXVOMICA+POWDEREA

GINGER+ASAFETIDA+CAPSICUM+CASCARASAGRADA EXTRACT

DIATRIZOATE SODIUM

DIAZEPAM

1 4 2 - 7- 4 2 - 6- 1 3 - 41 - - - 1- 1 - - 1

- 7 4 - 11- 1 - - 1

- 1 - - 1

- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 1 - 3- 1 - - 1- - 2 - 2- - 1 - 1- 2 2 - 4- - - 1 1

RASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PUSTULARSTEVENS JOHNSON

SYNDROMEURTICARIAURTICARIA

URTICARIA

PRURITUSRASHERYTHEMA MULTIFORMERASH ERYTHEMATOUSANGIOEDEMAPRURITUSRASHURTICARIARASHVASCULITISRASHDERMATITIS

DYSPNOEAFLUSHINGURTICARIAAKATHISIAANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANGIOEDEMAARTHRALGIABRONCHOSPASMCONFUSIONDYSKINESIADYSPHAGIADYSPNOEADYSTONIAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFIXED ERUPTIONHEADACHE

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DIAZEPAM

DICHLOROBENZYLALCOHOL, THROAT PREPARATION

DICLOFENAC

- 1 - - 1- 1 - - 11 - - - 1- 1 - 1 4- 1 - - 1- - 1 - 1- - 1 - 1- 1 2 - 3- 5 4 - 9- 1 - - 1- 2 1 - 3- 1 2 - 3- - 1 - 1

- 1 - - 1- - 1 - 1- 2 3 - 5- 1 - - 1- 1 1 1 3- - 1 - 1- - 1 - 1- 3 - - 3- 1 - - 1- - 1 - 1- 2 - - 2- 1 - - 1- - 2 - 21 15 4 - 203 27 5 - 35- 1 - - 1- 8 1 - 910 56 13 - 79- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- 12 4 - 16- 1 - - 1- 2 - - 2- - 1 - 1- 3 3 - 6- 1 - - 1

HYPERBILIRUBINAEMIALIP SORENESSLIPODYSTROPHYNAUSEAOEDEMAOEDEMA MOUTHPALPITATIONPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARREFLEX PLANTAR

EXTENSORSYNCOPETHROMBOPHLEBITISURTICARIAVAGINITISVOMITINGRASH ERYTHEMATOUSRASH MACULO-PAPULARABDOMINAL PAINALLERGIC CONJUNCTIVITISANAEMIAANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAAPNOEAARTHRALGIAASTHMAASTHMA EXTRINSICBELLY ACHEBLEPHARITISBRONCHIAL OBSTRUCTIONBRONCHOSPASMBUCCAL INFLAMMATIONBULLOUS ERUPTIONBURNING MUCOSALCHEILITISCHEMOSIS

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Spontaneous Report of Adverse Drug Reaction 2004 83

DICLOFENAC - 1 - - 1

2 4 1 - 7

- 1 - - 1

1 2 - - 3

- 1 - - 1

- 2 - - 2

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 2 - - 2

- - 1 - 1

1 5 5 - 11

- 2 - - 2

- 1 - - 1

- 1 - - 1

8 42 16 - 66

- 2 1 - 3

- 2 - - 2

- 2 - - 2

- 4 3 - 7

- 1 - - 1

- - 1 - 1

6 47 23 - 76

1 4 - - 5

- 5 2 - 7

1 11 4 - 16

- - 1 - 1

- 1 - - 1

- 2 1 - 3

- 1 - - 1

- 1 1 - 2

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 3 - 5

- 1 - - 1

- - - 1 1

- - 1 - 1

CHEST CONGESTION

CHEST PAIN

CHILLS

CONJUNCTIVITIS

CONSTIPATION

COUGHING

CYANOSIS

DERMATITIS

DERMATITIS CONTACT

DERMATITIS EXFOLIATIVE

DIARRHOEA

DIZZINESS

FIX ERUPTION

DYSPEPSIA

DYSPHASIA

DYSPNOEA

ECZEMA

ERUPTION

ERYTHEMA

ERYTHEMA MULTIFORME

EXTRAPYRAMIDAL DISORDER

EYELID INFECTION

FACE OEDEMA

FATIGUE

FEVER

FIXED ERUPTION

FLATULENCE

FLUID RETENTION IN TISSUES

FLUSHING

GASPING

GASTRITIS

GASTRITIS HAEMORRHAGIC

GASTROINTESTINAL TRACT

BLEED NOS

GI HAEMORRHAGE

GINGIVITIS

HAEMORRHAGE GASTRIC

HEADACHE

HEPATOTOXIC EFFECT

HOT DRY SKIN

HYPERSENSITIVITY

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DICLOFENAC - 2 - - 2- 4 - - 4- - 1 - 1- 1 - - 1- 2 - - 2

- 1 - - 1- - 1 - 1

1 1 1 - 3- 1 - - 12 11 5 - 18- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 12 17 8 - 271 - - - 1- 4 - - 4- 1 - - 11 6 2 - 93 15 5 1 24- 2 2 - 48 64 25 - 97- 2 1 - 3- 1 - - 11 - - - 14 12 7 - 231 1 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 2 - - 2

- 1 - - 1- 1 - - 1

- - 1 - 1

6 78 36 2 123

HYPERTENSIONHYPOTENSIONICHTHYOSISLARYNGEAL OEDEMALIPS SWELLING

NON-SPECIFICMACULAR RASHMINIMAL BRAIN

DYSFUNCTIONMOUTH DRYMOUTH ULCERATIONNAUSEANEUROLOGIC

DISORDER NOSNEUROPATHYNOSE CONGESTIONNUMBNESS ORALNYSTAGMUSOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA GENITALOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALORAL ULCERATIONPAINPALPITATIONPAPILLOEDEMAPAPULAR RASHPARAESTHESIAPARAESTHESIA MOUTHPEPTIC ULCERPETECHIAEPHOTOSENSITIVITY ALLERGIC

REACTIONPHOTOSENSITIVITY REACTIONPHOTOSENSITIVITY TOXIC

REACTIONPROTHROMBIN TIME

PROLONGEDPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 85

DICLOFENAC

DICLOFENAC FOR INJECTION

- - 1 - 16 79 43 1 130- 1 - - 1- 42 20 2 641 29 17 - 47- 1 - - 1- - 1 - 1

- 3 4 - 7- 1 - - 1

- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 6 6 - 12

- 2 1 - 3- 1 - - 1- 2 3 - 5- 2 1 - 31 - - - 1- 3 - - 3

- - 1 - 1- - 1 - 16 61 32 - 99- 1 - - 11 - - - 1- 1 1 - 21 1 - - 22 8 5 - 15- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 2 - - 2- 3 - - 32 6 - - 8- 1 - - 1- 1 - - 1- 1 - - 12 5 1 - 8- 1 - - 1

PURPURARASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICREFLEX PLANTAR

EXTENSORRENAL FAILURE ACUTERENAL FUNCTION

ABNORMALRESPIRATORY DEPRESSIONSERUM SICKNESSSHOCKSIADHSKIN EXFOLIATIONSPUTUM INCREASEDSTEVENS JOHNSON

SYNDROMESTOMATITISSUFFOCATION FEELINGSWEATING INCREASEDSYNCOPETINNITUSTOXIC EPIDERMAL

NECROLYSISTREMORUNCONSCIOUSNESSURTICARIAURTICARIA VESICULOSAVASCULITISVESICULAR RASHVISION BLURREDVOMITINGVOMITING AGGRAVATEDWEAKNESS GENERALIZEDWHEEZESANAESTHESIA TONGUEANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMACHEST PAINDIZZINESSDROWSINESSDYSPNOEAERYTHEMA MULTIFORME

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DICLOFENAC FOR INJECTION

DICLOFENAC FOR TOPICAL

DICLOXACILLIN

1 1 1 - 3- - 1 - 1- - 1 - 1- - - 1 11 - - - 1

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 12 11 1 - 14- - 1 - 1- 1 - - 12 7 3 1 13- 1 - - 1- 8 5 1 14- 3 3 - 6- 2 - - 2- - 1 - 12 5 1 - 8- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 4 1 - 5- 5 - - 5- 2 - - 2- 2 - - 2- 7 6 - 13- 3 - - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 2 - 2- 2 3 - 5- 10 6 - 16- 2 1 - 3- - 1 - 1- 2 - - 21 2 1 - 4- 1 1 - 2

FACE OEDEMAFIXED ERUPTIONGINGIVITISHOT DRY SKININJECTION SITE

INFLAMATORYNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPRURITUSPURPURA ALLERGICRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSCLERITISURTICARIAVERTIGOVOMITINGWHEEZING EXPIRATORYPRURITUSRASHABDOMINAL PAINAGITATIONANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONBURNING SENSATIONCHILLSDERMATITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAECZEMAERUPTIONERYTHEMAERYTHEMA MULTIFORMEERYTHROMELALGIA

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Spontaneous Report of Adverse Drug Reaction 2004 87

DICLOXACILLIN

DICYCLOMINE

DICYCLOMINE + SIMETHICONE

DIDANOSINE

1 - - - 1- 1 - - 1- 11 9 - 20- 1 - 1 2- 2 2 - 4- 1 1 1 31 1 2 - 4- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 3 1 - 4- 1 1 - 2- - 1 - 1- - 1 - 1- - 1 - 11 2 2 - 5- 6 5 - 11- 1 1 - 2- 7 2 - 91 12 7 - 20- 4 2 - 6- 1 - - 1- 57 35 - 922 62 36 2 102- 30 27 - 571 37 9 1 48- - 1 - 1- 1 - - 1- 2 2 - 4

- - 1 - 1- 1 - - 1- 2 - - 2

3 36 19 - 58- - 1 - 11 3 3 - 7- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

EYE IRRITATIONEYE PAINFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONHEADACHEHEPATITISHOT DRY SKINHYPOTENSIONINJECTION SITE

REACTIONMORBILLIFORM RASHMOUTH DRYMOUTH IRRITATIONMOUTH ULCERATIONMYALGIANAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPERITONITISPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH NEONATALRASH PURPURICSTEVENS JOHNSON

SYNDROMETHROAT TIGHTNESSTINNITUSTOXIC EPIDERMAL

NECROLYSISURTICARIAVESICULAR RASHVOMITINGBRONCHOSPASMURTICARIAPRURITUSRASH ERYTHEMATOUSACIDOSIS LACTICANAESTHESIA LOCAL

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DIDANOSINE

DIETHYLCARBAMAPINEDIETHYLSTILBESTROLDIFLUNISAL

DIGOXIN

DIHYDRALAZINE

DIIODOHYDROXYQUINOLINEDIIODOHYDROXYQUINOLINE + FURAZOLIDONE +

NEOMYCIN + PHTHALYLSULFATHIAZOLE + KAOLIN

- 1 - - 1- 4 6 - 10- 1 - - 1- 2 2 - 4- - 1 - 1- - 1 - 1- 3 - - 3- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1

1 3 1 - 5- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 1 2 - 4- 1 - - 1- 1 - - 11 2 - - 31 1 - - 2- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

CHEST PAINDIARRHOEAHEADACHELIPODYSTROPHYNAUSEANEUROPATHY PERIPHERALPRURITUSRASHVOMITINGTACHYCARDIAURTICARIAFIXED ERUPTIONOEDEMA PERIORBITALARRHYTHMIAAV BLOCK SECOND

DEGREEBRADYCARDIADEBILITYDIZZINESSDYSPNOEAECG ABNORMAL

SPECIFICECG/EKG CHANGES

NON-SPECIFICFIXED ERUPTIONHEART BLOCKHEPATITISMOUTH ULCERATIONNAUSEAOEDEMA LEGSPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSSALT INTOXICATIONTACHYCARDIAVERTIGOVISION ABNORMALVOMITINGBRONCHOSPASMDYSPNOEAURTICARIARASH ERYTHEMATOUSDYSPNOEAFACE OEDEMAHYPOTENSION

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Spontaneous Report of Adverse Drug Reaction 2004 89

DIIODOHYDROXYQUINOLINE + FURAZOLIDONE +NEOMYCIN + PHTHALYLSULFATHIAZOLE + KAOLIN

DILTIAZEM

DIMENHYDRINATE

- 5 - - 5- 6 1 - 7- 1 1 - 2- 3 2 - 5- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 3 - - 3- 2 3 - 5- 2 - - 2- 2 - - 2- 2 - - 2- - 1 - 1- 1 - - 12 - - - 2- 2 - - 2- 3 - - 3- 1 - - 1

- 1 - - 12 - - - 2- 3 - - 3- 1 1 - 2- 1 - - 1- - 3 - 31 5 1 - 7- 2 - - 2- 1 - - 1

- 1 2 - 3- - 1 - 14 27 5 - 36- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 1 - 22 6 - - 8- 3 3 - 6- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSURTICARIAANOREXIAARRHYTHMIABONE PAINBRADYCARDIAFATIGUEFEVEROEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSINUS BRADYCARDIAVOMITINGANAESTHESIA LOCALANAPHYLACTIC REACTIONANAPHYLAXISANGIOEDEMABLOOD PRESSURE

DROP ARTERIALBRONCHOSPASMBULLOUS ERUPTIONCHEST PAINCONVULSIONSDERMATITISDIZZINESSDYSPNOEAERYTHEMA MULTIFORMEEXTRAPYRAMIDAL

DISORDERFACE OEDEMAFEVERFIXED ERUPTIONFLUSHINGHYPOTHERMIAMACULAR RASHMOUTH DRYMYALGIANAUSEAOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERAL

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DIMENHYDRINATE

DIOSMIN+HESPERIDIN

DIPHENHYDRAMINE

DIPHENHYDRAMINE + AMMONIUM CHLORIDE +SODIUM CITRATE

DIPHTHERIA PERTUSSIS VACCINE

DIPHTHERIA TOXOID

DIPHTHERIA+HEMOPHILUS INFLUENZAE B+PERTUSSIS+POLIOMYELITIS+TETANUS+HEPATITIS B

- 2 1 - 32 6 5 - 13- 1 - - 11 12 7 - 20- 5 1 - 61 2 3 - 6- - 1 - 1- - 1 - 1

- 1 1 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 3 - - 3

- - 1 - 1- 5 2 - 7- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1

- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1

- - 1 - 1- - 1 - 1- - 17 - 17- - 2 - 2- - 4 - 4

PALPITATIONPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSPASM GENERALIZEDSTEVENS JOHNSON

SYNDROMESTOMATITISSYNCOPETONGUE DISORDERTONGUE OEDEMATOXIC EPIDERMAL

NECROLYSISTREMORURTICARIAVERTIGOVOMITINGWEAKNESS GENERALIZEDWHEALSEPIGASTRIC PAIN NOT

FOOD-RELATEDOEDEMAPRURITUSRASHRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTREMORPRURITUSRASH ERYTHEMATOUSCHILLSCONVULSIONSFEVERPALLORPRURITUSURTICARIAFEVERINJECTION SITE

INFLAMMATIONRASHDIARRHOEAFEVERINJECTION SITE PAINOEDEMA

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Spontaneous Report of Adverse Drug Reaction 2004 91

DIPHTHERIA+HEMOPHILUS INFLUENZAE B+PERTUSSIS+POLIOMYELITIS+TETANUS+HEPATITIS B

DIPHTHERIA+HEPATITIS B+TETANUS

DIPHTHERIA-TETANUS

DIPYRIDAMOLE

DIPYRIDAMOLE + ACETYLSALIC ACIDDISULFIRAM

DOCETAXEL

DOMPERIDONE

- - 1 - 1- - 3 - 3- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 4 - 4- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 2 6 9- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 4 1 1 6- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 2 - - 2- 1 - - 1- 2 - - 2- 1 - - 1

- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1

OEDEMA LEGSRASHRASH ERYTHEMATOUSFEVERHYPERPYREXIAOEDEMARASHRASH ERYTHEMATOUSFEVERPRURITUSRASHRASH ERYTHEMATOUSANGIOEDEMAFEVERFLUSHINGRASH ERYTHEMATOUSHEADACHECHEST DISCOMFORTCONFUSIONDIZZINESSDYSPNOEAHEADACHEPALPITATIONPARAESTHESIAURTICARIACHEST PAINFLUSHINGHYPERSENSITIVITYNAUSEANEUTROPENIAVOMITINGANAESTHESIA LOCALANGIOEDEMABRONCHOSPASMCONVULSIONSDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAERYTHEMAEXTRAPYRAMIDAL DISORDEREXTRAPYRAMIDAL DISORDER

AGGRAVATEFIXED ERUPTIONLOCKJAWMACULAR RASHNAUSEA

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DOMPERIDONE

DONEPEZIL

DORZOLAMINEDOXAZOSIN MESYLATE

DOXORUBICIN

DOXYCYCLINE

- 2 2 - 4- 2 1 - 3- 1 - - 1- 1 - - 1- - 1 - 1- 7 5 1 13- 5 5 - 10- - 1 - 1- 3 2 - 5- 1 - - 1- - 1 - 1

- 10 6 - 16- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 - 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 21 4 1 - 6- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- 1 1 - 2- - 1 - 1- 2 2 - 4- 1 - - 1- 1 - - 1

OEDEMA MOUTHOEDEMA PERIORBITALPAINPAPULAR RASHPARAESTHESIAPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSTONGUE PARALYSISTOXIC EPIDERMAL

NECROLYSISURTICARIAVERTIGOCHEILITISDERMATITISDIARRHOEAGASTRITISURTICARIAVOMITINGOEDEMA PERIORBITALCHEST TIGHTNESS OFDIZZINESSFACE OEDEMAFLUSHINGHYPOTENSIONMYALGIAOEDEMA MOUTHSYNCOPEPHOTOSENSITIVITY REACTIONTHROMBOCYTOPENIAABDOMINAL PAINABSCESSANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANGIOEDEMAANOREXIACHEST PAINDERMATITIS EXFOLIATIVEDIZZINESSDRUG ERUPTIONDYSPEPSIADYSPNOEAECZEMAERYTHEMA

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Spontaneous Report of Adverse Drug Reaction 2004 93

DOXYCYCLINE

DROTAVERINE

DROTAVERINE HYDROCHLORIDE

DTP (DIPHTHERIA-TETANUS-PERTUSSIS)

- 2 1 - 3- - 1 - 1- 2 1 - 3- 13 2 - 15- - 1 - 1

- - 2 - 2- 1 - - 1- 1 - - 11 2 3 - 6- 3 2 - 5- 6 2 - 8- 2 1 - 3- - 1 - 1- 2 - - 2- 1 - - 1

- 1 2 - 31 10 17 1 29- 1 - - 1- 16 16 1 331 10 9 - 20- 22 8 - 30- 1 - - 1- 7 - - 7

- 2 1 - 3- 1 - - 1- - - 1 1

- 4 6 - 101 1 4 - 6- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 9 - 10- 1 1 - 2

ERYTHEMA MULTIFORMEEYE PAINFACE OEDEMAFIXED ERUPTIONGENITAL ERUPTION

FEMALELIP ULCERATIONMOUTH ULCERATIONNAIL DISORDERNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPAINPARAESTHESIAPHOTOSENSITIVITY ALLERGIC

REACTIONPHOTOSENSITIVITY REACTIONPRURITUSPRURITUS GENITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATION LABOREDSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGWHEALSCHEILITISDYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSURTICARIAPRURITUSRASH ERYTHEMATOUSCYANOSISFATIGUEFEVERRASH

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DTP (DIPHTHERIA-TETANUS-PERTUSSIS)

DTP+HAEMOPHILUS INFLUENZAE B+POLIOMYELITIS(PENTACT-HIB)

DTP+R-DNA HEPATITIS B VIRUSANTIGEN (TRITANRIX HB)

DTP+R-DNA HEPATITISB+INACTIVEDPOLIOVIRUS TYPE1,2,3+INFLUENZAE TYPE BCONJUGATE TO TETANUS PROTEIN

ECONAZOLEEFAVIRENZ

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 6 - 6- - 1 - 1- - 4 - 4- - 1 - 1- - 1 - 1- - 9 - 9- - 1 - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1

4 18 11 1 34- 1 - - 1- - 2 - 2- 1 2 - 3- 1 1 - 2- - 2 - 2- - 1 - 1- 2 - - 2- 1 1 - 2

- 1 - - 1

- 5 1 - 6- 3 1 - 4- 1 - - 1- - 1 - 11 - 2 1 4- 1 - - 1

RIGORSSHIVERINGTREMORURTICARIAVOMITINGFEVERRASHFEVERRASHVOMITINGFEVERINJECTION SITE

INFLAMMATIONRASHABDOMINAL PAINABSCESSANAEMIAANOREXIABILIRUBINAEMIABULLOUS ERUPTIONCONFUSIONCONJUNCTIVITISDELUSIONDEPRESSIONDERMATITIS EXFOLIATIVEDERMATITIS EXFOLIATIVE

AGGRAVATEDDIZZINESSDREAM DELIRIUMERYTHEMAERYTHEMA MULTIFORMEFEVERGYNAECOMASTIAHALLUCINATIONHEADACHEHEPATIC ENZYMES

INCREASEDHEPATIC FUNCTION

ABNORMALHEPATITISHEPATOTOXIC EFFECTHYPERCHOLESTEROLAEMIAHYPERPIGMENTATION SKININSOMNIAJAUNDICE

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Spontaneous Report of Adverse Drug Reaction 2004 95

EFAVIRENZ

ENALAPRIL

- 2 - - 2- 1 - - 1

- 1 - - 1- 4 2 - 6- - 1 - 1- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- 2 1 - 3- 5 2 - 7- 3 2 - 51 11 4 - 16- 1 - - 1- 1 - - 1- - 1 - 1- 3 - - 3

- 2 1 - 3- 1 - - 1- - 1 - 1- 5 1 - 6- 1 - - 1- 1 - - 1

- 1 - - 11 - - - 1- 1 1 - 29 65 18 - 92- 1 - - 1- 1 - - 1- 1 - - 1- 1 2 - 3- 1 - - 1- 2 2 - 4- - 1 - 1- 1 - - 11 5 3 - 9- 1 1 - 2- - 1 - 1- - 1 - 1- 1 2 - 3- 1 1 - 2- 1 - - 1

LEUCOPENIAMORNING GLORY

SYNDROMEMYALGIANAUSEANEUROPATHYNIGHTMARESOEDEMAPARAESTHESIA SKINPHOTOSENSITIVITY REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSGOT INCREASEDSGPT INCREASEDSOMNOLENCESTEVENS JOHNSON

SYNDROMEVOMITINGWEIGHT DECREASEABDOMINAL PAINANGIOEDEMAARTHRALGIABLOOD UREA NITROGEN

INCREASEDBRONCHITISCHEILITISCHEST PAINCOUGHINGDERMATITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDRUG ERUPTIONDYSPNOEAERYTHEMA MULTIFORMEEYE ABNORMALITYFACE OEDEMAFATIGUEFOLLICULITISGUM HYPERPLASIAHEADACHEHYPERKALAEMIALEG PAIN

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ENALAPRIL

ENOXAPARIN SODIUM

EPERISONE

EPHEDRINEEQUINE RABIES IMMUNOGLOBULIN

- 4 - - 4- - 1 - 1- 1 - - 1- 1 - - 1- 4 4 - 8- 1 3 - 4- 1 1 - 2- 1 1 - 2- - 1 - 1- 1 - - 1- 3 4 - 71 8 9 - 18- 1 - - 1- 4 4 - 8- - 1 - 11 4 1 - 6- 1 - - 1- 1 1 - 2

- - 1 - 1- 1 - - 12 1 5 1 9- 2 - - 2- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 2 - 3- - 1 - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 3 3 - 6- - 2 - 2- - 1 - 1- - 1 - 1- 2 - - 2- - 1 - 1- - 1 - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

NAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPARAESTHESIA CIRCUMORALPERIPHERAL COLDNESSPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRENAL FAILURE ACUTESOMNOLENCESTEVENS JOHNSON

SYNDROMETONGUE ULCERATIONURINARY RETENTIONURTICARIAVOMITINGABDOMINAL PAINHAEMATOMAHAEMATURIAHAEMORRHAGE NOSOEDEMA PERIORBITALRASHABDOMINAL PAINDIZZINESSDYSPNOEAFACE OEDEMAFATIGUEINSOMNIANAUSEAOEDEMA PERIORBITALOEDEMA PERIPHERALPRURITUSRASHRASH ERYTHEMATOUSTINNITUSVOMITINGRASH MACULO-PAPULARANAPHYLACTIC SHOCKANGIOEDEMAERYTHEMA

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Spontaneous Report of Adverse Drug Reaction 2004 97

EQUINE RABIES IMMUNOGLOBULIN

ERGOT ALKALOIDSERGOTAMINE

ERGOTAMINE TARTRATE + CAFFEINE

ERTAPENEM

- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - - 1 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- - 1 - 1- 1 - - 1- 2 - - 2- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 31 - - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 4 - - 4- - - 1 1- - 1 - 1- - 1 - 1- 3 - - 3- 1 2 - 3- - 1 - 11 - - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 3 - - 3

- 3 - - 3- - 1 - 1

INJECTION SITE REACTIONOEDEMARASHURTICARIAFACE OEDEMABRONCHOSPASMDYSPNOEAFACE OEDEMAPRURITUSRASHVOMITINGABDOMINAL PAINCHEST PAINDIZZINESSDYSPNOEAFACE OEDEMAFATIGUEHEADACHENAUSEAOEDEMAOEDEMA GENERALISEDPALPITATIONPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARSWEATING INCREASEDURTICARIAVERTIGOVISION BLURREDVOMITINGANOREXIACHEST PAINCONFUSIONDEPRESSIONDIARRHOEADIZZINESSDROWSINESSDYSURIAINSOMNIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPONSES VOLUNTARY

REDUCEDSLEEP DISORDERUNCONSCIOUSNESS

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ERYTHROMYCIN

ERYTHROMYCIN ESTOLATE

- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 11 3 3 - 7- 1 - - 1- 1 1 - 2- 1 - - 1- 2 3 - 5- - 1 - 1- 1 - - 1- 2 2 - 4- 1 1 - 2- 4 - - 4- 1 - - 1- 1 - - 1- 2 2 - 4- 1 1 - 2- 1 - - 1- - 1 - 1- - 2 - 2- 1 4 - 5- - 2 - 2- 5 9 1 15- - 1 - 12 12 10 - 25- 6 8 2 161 5 6 - 12- - 1 - 1- - 1 - 1- 1 - - 1

- 1 - - 11 12 8 - 21- 2 2 - 4- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1

- - 1 - 1

ABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABULLOUS ERUPTIONCHEST PAINDIARRHOEADYSPNOEAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONHEADACHEMORBILLIFORM RASHNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA GENITALOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSPRURITUS GENITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMETACHYCARDIAURTICARIAVOMITINGCONJUNCTIVITISDYSPNOEAERYTHEMA MULTIFORMEORAL ULCERATIONPAPULAR RASHPRURITUSRASHRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMEURTICARIA

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Spontaneous Report of Adverse Drug Reaction 2004 99

ERYTHROMYCIN STEARATE

ERYTHROPOIETIN ALFA

ERYTHROPOIETIN BETAESCITALOPRAM

ESOMEPRAZOLE

ESSENTIAL PHOSPHOLIPIDSUBSTANCES + VITAMINS

ESTRADIOL, COMBINATIONS

ETHAMBUTOL

- - 1 - 1- - 1 - 1- 3 3 - 6- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- 1 1 - 2- 1 - - 1- - 3 - 3- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - - 1 1- 1 - - 1- - - 1 1- - 1 - 1- - 1 - 1- 1 - - 1

- 1 - - 1- - 2 - 2- 1 - - 1- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 11 - - - 11 4 2 - 7- 1 - - 1- 1 - - 11 1 - - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 11 - 2 - 3- - 2 - 21 1 - - 2- 1 1 - 2

ABDOMINAL PAINNAUSEAAPLASIA, PURE RED CELLEFFICACY, LACK OFPALPITATIONRESTLESSNESS AGGRAVATEDEFFICACY, LACK OFDIZZINESSMOUTH DRYNAUSEAPALPITATIONSOMNOLENCETINNITUSVOMITINGABDOMINAL PAINPRURITUSRASHRASH MACULO-PAPULARDIZZINESSRASHSYNCOPEPRURITUSRASH ERYTHEMATOUSADAMS STOKES

SYNDROMEANOREXIAARTHRALGIABLINDNESS COLOURBULLOUS ERUPTIONCHEST PAINCHOLELITHIASISCOUGHINGDERMATITISDERMATITIS EXFOLIATIVEDIPLOPIADYSPNOEAERYTHEMAERYTHEMA MULTIFORMEERYTHROMELALGIAEYE ABNORMALITYFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONHEADACHE

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ETHAMBUTOL

ETHAMBUTOL, COMBINATIONS

ETHIONAMIDE

ETHYL LOFLAZEPATE

- - 1 - 1

- 13 7 - 20- 1 - - 1- 1 - - 1- 3 5 - 8- - 1 - 11 - - - 11 2 2 - 5- 1 - - 1- 1 - - 1- - 1 - 1- 2 1 - 3- - 2 - 21 - - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 11 7 - 18- 9 14 - 23- 4 2 - 61 12 2 - 15- 1 - - 1- - 2 - 2- 3 3 - 6

- 1 - - 1- 1 - - 1- 1 - - 1

- 4 2 - 6- 1 - - 11 1 - - 2- 4 - - 4- 1 - - 1- 1 - - 11 2 1 - 41 - - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

HEPATIC ENZYMESINCREASED

HEPATITISHEPATOTOXIC EFFECTHYPERBILIRUBINAEMIAJAUNDICEJAUNDICE CHOLESTATICMACULAR RASHNAUSEANEUROPATHYOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOPTIC NEURITISPAINPALPITATIONPAPULOVESICULAR RASHPERIPHERAL NEURITISPHARYNGITISPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSGOT INCREASEDSKIN NODULESTEVENS JOHNSON

SYNDROMESUFFOCATION FEELINGTONGUE OEDEMATOXIC EPIDERMAL

NECROLYSISURTICARIAVERTIGOVISION ABNORMALVISION BLURREDVISION DECREASEDVISUAL FIELD DEFECTVOMITINGDERMATITIS EXFOLIATIVESTOMATITISACNEIFORM DERMATITISCONFUSIONDIZZINESSERUPTIONPRURITUSRASHDROWSINESS

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Spontaneous Report of Adverse Drug Reaction 2004 101

ETILEFRINEETOPOSIDE

ETORICOXIB

EVEROLIMUSEZETIMIBEFAMCICLOVIR

FAMOTIDINEFAT EMULSIONS

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 3 - 3- 2 7 - 9- 1 1 - 2- - 1 - 1- 1 5 - 6- - 5 - 5- 4 3 - 7- - 1 - 1- 1 3 - 4- - 1 - 1- 1 - - 1- - 2 - 2- 1 - - 1- - 1 - 1- 2 - - 2- 3 3 - 6- 2 8 1 11- 1 1 - 2- 1 - - 1- 1 2 - 3- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 3 - 3- - 1 - 1- 3 1 - 4- 4 5 - 9- 4 1 - 5- 1 - - 1- 1 1 - 2- - 2 - 2- 1 - - 1- 1 1 - 2- - - 1 1- - 1 - 11 - - - 1- - 1 - 11 - - - 1- 1 - - 1- 1 - - 1

PALPITATIONANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKDYSPNOEARASHTHROMBOCYTOPENIAABDOMINAL DISCOMFORTABDOMINAL PAINANGIOEDEMAANTICHOLINERGIC SYNDROMEDIZZINESSDYSPEPSIAFACE OEDEMAFATIGUEFLATULENCEFLUSHINGHEADACHEHYPERTENSIONINSOMNIAMICTURITION FREQUENCYMOUTH ULCERATIONNAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALOLIGURIAORAL ULCERATIONPAINPALPITATIONPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTOMATITISTASTE BITTERTONGUE DISORDERVOMITINGTHROMBOSISNAUSEANAUSEARASHVOMITINGFIXED ERUPTIONFLUSHING

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FAT EMULSIONS

FBC (FERROUS FUMARATE + VITAMIN B +VITAMIN C + FOLIC ACID + CALCIUM PHOSPHATE

FELODIPINE

FENBUFENFENOFIBRATE

FENOVERINEFENTANYL

FERROUS FUMARATE

FERROUS FUMARATE + CALCIUM LACTATEFERROUS FUMARATE +VITAMIN A +VITAMIN B +

VITAMIN C+VITAMIN D+CALCIUM PANTOTHENATE

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 1 - - 11 - 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 1 2- 1 - - 11 - - - 11 - - - 1- - 1 - 11 - - - 1- 2 - - 2- 1 - - 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

HEADACHENAUSEAVOMITINGFLUSHINGHEADACHENAUSEAPRURITUSRASHURTICARIAVOMITINGDERMATITIS EXFOLIATIVEDIZZINESSFASCITIS PLANTARFEVERHEADACHEOEDEMA LEGSPALPITATIONRASHRASH ERYTHEMATOUSTREMORURTICARIAVERTIGORASH MACULO-PAPULARDIARRHOEADRUG ERUPTIONEXANTHEMAHEPATITISJAUNDICE CHOLESTATICPHOTOSENSITIVITY

ALLERGIC REACTIONRASHRASH MACULO-PAPULARRENAL FAILURE ACUTERHABDOMYOLYSISVOMITINGORAL DRYNESSRASH ERYTHEMATOUSRASH MACULO-PAPULARRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASHDIZZINESSDYSPNOEAFEVEROEDEMAPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 103

FERROUS FUMARATE + VITAMIN A + VITAMIN B +VITAMIN C+VITAMIN D + CALCIUM PANTOTHENATE

FERROUS FUMARATE + VIT B1 + VIT B2 + VIT B12 +VIT C + NIACIN + FOLIC ACID + CALCIUMPHOSPHATE TRIBASIC

FERROUS FUMARATE + VITAMIN B1-B2-B6-B12 +VIT. C + VIT. D + CALCIUM PHOSPHATE DIBASIC

FERROUS SULFATE + VITAMIN B1-B6-B12FERROUS SULPHATE

FEXOFENADINE

FIBRATESFILGRASTIM

FLATULENCEFLAVONOIDIC FRACTION

FLAVOXATE

- - 1 - 1- - 1 - 1- 1 - - 1

- - 1 - 1

- 1 1 - 2- - 1 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 1 2- - 1 - 1- - - 1 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 11 - - - 11 - - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 11 - - - 11 - - - 11 - - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1

RASHRASH MACULO-PAPULARRASH

STEVENS JOHNSONSYNDROME

RASHANAESTHESIA MOUTHANGIOEDEMAEYE IRRITATIONMOUTH DRYOEDEMAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAABDOMINAL DISCOMFORTCHEST PAINDIZZINESSERYTHEMA MULTIFORMEHEADACHEINSOMNIAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSSOMNOLENCESYNCOPEUREA DECREASEDGI HAEMORRHAGEBACK ACHECHILLSFEVERPAINPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARTONGUE PARALYSISASTHENIAFATIGUEPALPITATIONRASHANGIOEDEMAFATIGUEMOUTH IRRITATION

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FLAVOXATE

FLOCTAFENINE

FLUCONAZOLE

- 1 - - 1

- 1 - - 1

- - 1 - 1

- - 2 - 2

- 1 - - 1

- 1 - - 1

- 4 2 - 6

- 1 - - 1

- 1 - - 1

- 2 - - 2

- - 1 - 1

- 5 2 - 7

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 5 2 - 7

- 1 - - 1

- - 1 - 1

- - 2 - 2

- - 1 - 1

- - 1 - 1

- 1 - - 1

- 2 - - 2

1 10 8 - 19

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 11 2 - 13

- 9 6 - 15

- 6 8 - 14

1 3 1 - 5

- 1 - - 1

- 1 - - 1

- 5 3 - 8

- 1 - - 1

- 1 - - 1

- - 2 - 2

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 2 3 - 5

- - 1 - 1

RASH

RASH MACULO-PAPULAR

URTICARIA

ABDOMINAL PAIN

ANAPHYLACTIC REACTION

ANAPHYLACTIC SHOCK

ANGIOEDEMA

ANKLE OEDEMA

BREATHING DIFFICULT

CONJUNCTIVITIS

DIZZINESS

DYSPNOEA

ERYTHEMA

EYE ABNORMALITY

EYE IRRITATION

FACE OEDEMA

FIXED ERUPTION

HYPERTENSION

NAUSEA

NEUROPATHY PERIPHERAL

NUMBNESS

NUMBNESS ORAL

OEDEMA

OEDEMA PERIORBITAL

PAIN

PALPITATION

PARAESTHESIA

PRURITUS

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

RED EYE

UNCONSCIOUSNESS

URTICARIA

VESICULAR RASH

VISION BLURRED

VOMITING

ANAPHYLACTIC REACTION

ANGIOEDEMA

CHEILITIS

DERMATITIS

DERMATITIS EXFOLIATIVE

DRUG ERUPTION

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Spontaneous Report of Adverse Drug Reaction 2004 105

FLUCONAZOLE

FLUNARIZINE

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 1 - - 1- 1 - - 1

- - 1 - 1- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

- 6 2 - 8- 1 - - 1- 4 5 - 9- 5 2 - 7- 4 5 - 9- 1 - - 1- 1 - - 1- - 1 - 1- 8 3 - 11

- - 1 - 1

- 1 - - 11 2 - - 3- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 2 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1

DYSPNOEAERUPTIONERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERHYPOKALAEMIAJAUNDICELIVER FUNCTION TESTS

ABNORMAL NOSMACULAR RASHOEDEMAOEDEMA MOUTHPALPITATIONPAPULAR RASHPARAESTHESIAPHOTOSENSITIVITY

REACTIONPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSGPT INCREASEDSKIN DRYSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMETOXIC EPIDERMAL

NECROLYSISTRUNK BOWED BACKURTICARIAVESICULAR ERUPTIONVISION ABNORMALANAPHYLACTIC SHOCKASTHENIACHEILITISCHEST PAINDIZZINESSDYSPNOEAFACE OEDEMAFATIGUEFIXED ERUPTIONHEADACHEINSOMNIA

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⌦106

FLUNARIZINE

FLUNITRAZEPAMFLUORIDE

FLUOROURACIL

FLUOXETINE

FLUPENTHIXOL

FLUPENTIXOL + MILITRACEN

FLUPHENAZINE

FLURBIOPROFENFLUTICASONE PROPIONATEFLUVASTATIN

- - 1 - 1- - - 1 1- - 1 - 1- 1 2 - 3- 2 2 - 4- 2 2 - 4- 1 1 - 2- 1 - - 1- 1 - - 1

- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 3 - - 3- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 1 - 2- 2 - - 2- 2 - - 2- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

NECK TIGHTNESSOEDEMA DEPENDENTOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEURTICARIAVISION BLURREDRASHOEDEMA MOUTHRASHNAUSEARASH MACULO-PAPULARVERTIGOVOMITINGATAXIADIZZINESSFATIGUEFIXED ERUPTIONHEADACHEPRURITUSRASH ERYTHEMATOUSSEROTONIN SYNDROMEURTICARIAVISION BLURREDAKATHISIADYSTONIADROWSINESSHYPOTENSIONRASHURTICARIAAKINESIADYSPHAGIADYSTONIAEXTRAPYRAMIDAL DISORDERMUSCLE RIGIDITYOCULOGYRIC CRISISPARKINSONISMTREMORTREMOR LIMBURTICARIAHOARSENESSMYALGIA

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Spontaneous Report of Adverse Drug Reaction 2004 107

FLUVASTATIN

FLUVOXAMINE

FOLIC ACID

FOSFOMYCIN

FOSINOPRIL+DIURETIC

FRESH FROZEN PLASMA

FURAZOLIDONE

- - 1 - 1- - 1 - 1

- 1 - - 1- 1 - - 1- - 1 - 1

- 1 2 - 3- - 1 - 1- 1 1 - 2- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 - - 1

- 2 - - 2- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - - 1 1- 1 - - 1- 1 - 1 2- 1 - - 1- 1 1 - 2- 3 1 - 4- 1 - - 1- 3 3 - 6- 3 1 - 4- 3 1 - 4- - 2 - 2- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

OEDEMA MOUTHTOXIC EPIDERMAL

NECROLYSISVERTIGOVOMITINGANTICHOLINERGIC

SYNDROMEDIZZINESSDYSPNOEANAUSEASOMNOLENCESYNCOPETREMORVOMITINGBURNING SENSATIONDIZZINESSFACE OEDEMANAUSEAOEDEMA OF

EXTREMITIESPRURITUSRASHRASH FOLLICULARRASH MACULO-PAPULARSYNCOPEURTICARIAVOMITINGANAESTHESIA MOUTHBRONCHOSPASMDRUG ERUPTIONDYSPNOEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIACOUGHINGDIZZINESSOEDEMA LEGSVERTIGOANAPHYLACTIC SHOCKRASH ERYTHEMATOUSDYSPNOEAERYTHEMAOEDEMA MOUTH

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FURAZOLIDONE

FURAZOLIDONE + KAOLIN + PECTIN +BELLADONA + PEPPERMINT OIL

FUROSEMIDE

FUSIDIC ACID

FUSIDIC ACID FOR TOPICAL

- 2 - - 2- 1 - - 1- 1 1 - 2- 1 - - 1

- - 1 - 1- - 1 - 1

- - 1 - 1- 1 - - 1- - - 1 1- 1 1 - 2- 1 - - 1- - - 1 11 - - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- 3 1 - 4- - 1 - 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 11 1 - - 2- 1 - - 1- 2 3 - 5- 1 2 - 3- - 2 - 2- 1 - - 1

- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 2 - 2- - 1 - 1- 1 1 - 2- 1 1 - 2- - 1 - 1- 1 - - 1

PRURITUSRASHRASH MACULO-PAPULARTONGUE SWELLING

NON-SPECIFICWHEALSRASH ERYTHEMATOUS

ABDOMINAL PAINALKALOSIS METABOLICCOUGHINGDERMATITIS EXFOLIATIVEELECTROLYTE ABNORMALITYERYTHEMA MULTIFORMEFACE OEDEMAFIXED ERUPTIONHEPATITISHOT DRY SKINHYPERPIGMENTATION SKINHYPOCHLORAEMIAHYPOKALAEMIAHYPOMAGNESAEMIAHYPONATRAEMIAHYPOPHOSPHATAEMIANAUSEAOEDEMA PERIORBITALPALPITATIONPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMETACHYCARDIATHROMBOCYTHAEMIATHROMBOCYTOPENIATONGUE ULCERATIONURTICARIAVERTIGOVOMITINGERYTHEMAPRURITUSRASHRASH FOLLICULARARTHRITIS RHEUMATOID

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Spontaneous Report of Adverse Drug Reaction 2004 109

FUSIDIC ACID FOR TOPICAL

GABAPENTIN

GALANTAMINE

GANIRELIX

GATIFLOXACIN

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 5 6 - 11- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 3 - 4- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 1 1 - 2- 2 1 - 3- 3 2 - 5- 3 - - 3- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 5 - - 5- 2 - - 2

CONJUNCTIVITISOEDEMA PERIORBITALPRURITUSABDOMINAL PAINATAXIACONFUSIONDEPRESSIONDIZZINESSFACE OEDEMAFIXED ERUPTIONHEART DISORDERHOT FLUSHESMIGRAINENAUSEAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIPHERALPAINPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSOMNOLENCESPASM GENERALIZEDURTICARIAVERTIGOVISION ABNORMALVOMITINGANOREXIADIZZINESSNEURALGIAHEADACHEINJECTION SITE

INFLAMMATIONPRURITUSRASHRASH ERYTHEMATOUSABDOMINAL PAINANAESTHESIA MOUTHANGIOEDEMABUCCAL INFLAMMATIONCHEST ACHEDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEA

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GATIFLOXACIN

GEFITINIB

GEMFIBROZIL

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1

- 1 1 - 2- 3 1 - 4- - 1 - 1- 5 1 - 6- 1 1 - 2- 1 2 - 3- 3 - - 3- 1 2 - 3- 1 - - 1- 1 - - 1- 2 2 - 4- 2 1 - 3- - 7 - 7- - 1 - 1- - 3 - 3- - 5 - 5- 2 4 - 61 3 1 - 5- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 3 1 - 4- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 11 - 1 - 2- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1

FATIGUEGI HAEMORRHAGEGLOSSITISHALLUCINATIONHEADACHEINJECTION SITE

BRUISINGINSOMNIANAUSEANUMBNESS ORALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSOMNOLENCETINNITUSVOMITINGACNEDIARRHOEAONYCHIAPRURITUSRASHSKIN DRYURTICARIAABDOMINAL PAINANAPHYLACTIC SHOCKANOREXIAAURABRONCHOSPASMCHEST PAINDIARRHOEADIZZINESSDYSPEPSIADYSPNOEAERYTHEMAERYTHRODERMAFACE OEDEMAFATIGUEFEVERHEADACHEHEPATITISHOT FLUSHESINFLUENZA-LIKE

SYMPTOMS

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Spontaneous Report of Adverse Drug Reaction 2004 111

GEMFIBROZIL

GENTAMICIN

- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 5 1 - 6- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 7 3 - 10- 5 6 - 11- 2 1 - 3- 3 1 - 4- 2 - - 21 - - - 11 - - - 1- 1 - - 1- 3 1 - 4- - 1 - 1- 1 - - 1- 1 2 - 3- - 1 - 1- 2 1 - 3- 2 - - 2- - 1 - 1- 2 3 - 5- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 2 - 31 8 10 - 19- - 1 - 11 13 24 1 39- 12 7 - 19- 11 8 - 19- 3 - - 3

MOUTH DRYMUSCLE WEAKNESSMYALGIAMYOPATHYNAUSEAOEDEMAOEDEMA PERIORBITALOEDEMA GENERALISEDORAL ULCERATIONPALPITATIONPARAESTHESIA MOUTHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRHABDOMYOLYSISRHAGADESSTOMATITISTACHYCARDIAURTICARIAVERTIGOVOMITINGANGIOEDEMAAPNOEABRONCHOSPASMCHEST PAINDERMATITIS EXFOLIATIVEDYSPNOEAEPIPHORAERYTHEMAEXANTHEMAFACE OEDEMAFIXED ERUPTIONHEADACHEMACULAR RASHOEDEMAOEDEMA PERIORBITALOEDEMA PERIPHERALPAINPALPITATIONPRURITUSPURPURA ALLERGICRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTE

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⌦112

GENTAMICIN

GESTODENE AND ESTROGENGINKGO BILOBAGLIBENCLAMIDE

GLICLAZIDE

GLIMEPIRIDE

GLIPIZIDE

- - 2 - 2- - 1 - 1- 12 8 1 21- - 1 - 1- - - 1 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 5 2 - 7- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 4 1 71 5 5 1 12- 1 - 1 2- 2 1 - 3- 1 - - 1

- 2 1 - 3- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- 1 - - 1

1 - - - 1- - 1 - 1

- - 1 - 11 - - - 11 - - - 11 - - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1

STOMATITISTINNITUSURTICARIAANOREXIAPALPITATIONANAESTHESIA LOCALBRONCHOSPASMBULLOUS ERUPTIONCOUGHINGDERMATITIS CONTACTDYSPNOEAEXTRAPYRAMIDAL DISORDEREYE PAINFACE OEDEMAFAINTNESSFEVERHEADACHEHYPOGLYCAEMIAMACULAR RASHMYALGIANAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEURTICARIAVISION ABNORMALVOMITINGANGIOEDEMAERYTHEMA MULTIFORMEHYPOGLYCAEMIAORAL MUCOSAL

ERUPTIONRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMEWEIGHT INCREASENAUSEAPALPITATIONVOMITINGBULLOUS ERUPTIONDERMATITIS EXFOLIATIVEHEADACHEHYPOGLYCAEMIA

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Spontaneous Report of Adverse Drug Reaction 2004 113

GLIPIZIDE

GLUCOSAMINE

GLUCOSAMINE POLYGLYCANSULPHATE

GLUCOSAMINE SULFATEGLYCERYL GUAIACOLATE

GRISEOFULVIN

- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 1 1 - 21 - - - 1- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- 2 1 - 3- 3 1 - 4- 3 - - 3- - 1 - 1- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1

- 12 3 - 15- 8 3 - 11- 3 3 - 6- 3 - - 3- 1 - - 1- - 1 - 1- - 1 - 1

- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSURTICARIACHEST PAINDYSPNOEANAUSEAOEDEMAOEDEMARASH ERYTHEMATOUSOEDEMA GENERALISEDFIXED ERUPTIONPRURITUSRASHURTICARIAANGIOEDEMACHEST PAINDERMATITIS EXFOLIATIVEDIZZINESSDRY LIPSDYSPNOEAECZEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONFLUSHINGLIP SORENESSNAUSEANUMBNESSOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIPHERALPALPITATIONPAPULAR RASHPHOTOSENSITIVITY ALLERGIC

REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSKIN EXFOLIATIONSOMNOLENCESTEVENS JOHNSON

SYNDROMETONGUE ULCERATION

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GRISEOFULVIN

GUAIFENESIN

HAEMOPHILUS INFLUENZAE B, OLIGOSACCHARIDEHALOPERIDOL

- - 1 - 1

2 4 4 - 10- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 10 4 - 14- 1 - - 1- 1 - - 1- 3 - - 3- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- - -- - -- 1 1 - 2- 5 2 - 7- 1 - - 1- 1 - - 1- 31 8 - 393 23 7 - 33

1 - - - 1- - 1 - 1

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 2 - - 2

- 1 - - 1- 1 - - 1- 1 2 - 3- - - - -- 5 - - 5- 3 1 - 4

TOXIC EPIDERMALNECROLYSIS

URTICARIAVESICULAR RASHVESICULOBULLOUS RASHVOMITINGWEIGHT INCREASEFACE OEDEMAPAPULAR RASHRASHRASH ERYTHEMATOUSURTICARIAPAINAKATHISIAAKINESIAALLERGIC REACTIONATAXIABRUISECONFUSIONDEPRESSIONDIZZINESSDROWSINESSDYSKINESIADYSPHAGIADYSPHONIADYSPNOEADYSTONIAEXTRAPYRAMIDAL

DISORDERFEVERHEAD-FACE-NECK

SYNDROMEHYPERPROLACTINAEMIAHYPERTONIAHYPONATRAEMIALIGHT-HEADED

FEELINGNASAL CONGESTIONNEUROLEPTIC MALIGNANT

SYNDROMEOCULOGYRIC CRISISOEDEMA PERIPHERALPALPITATIONPARALYSISPARKINSONISMPARKINSON'S SYNDROME

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Spontaneous Report of Adverse Drug Reaction 2004 115

HALOPERIDOL

HALOTHANE

HEPARIN

HEPATITIS B, PURIFIED ANTIGEN

HEXOPRENALINEHISTAMINEHUMAN ALBUMIN

HYDRALAZINE

HYDROCHLOROTHIAZIDE

- 1 - - 1- 1 1 - 2- 1 - - 11 3 1 - 5- 2 1 - 4- 2 2 - 4- 1 - - 1- 2 2 - 4- 1 - - 1- 2 - - 2- 1 - - 1

- 1 - - 1- 6 2 - 8- 1 - - 1- 1 1 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 11 - - - 1- - 1 - 1- - 1 - 11 - - - 11 - - - 1- - 1 - 1- 1 - - 11 1 - - 2- - 1 - 1- - 1 - 1

1 - - - 11 - - - 11 - - - 1- - 1 - 1- 1 - - 1

PRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSALIVA INCREASEDSIADHSLEEP DISORDERSPASM TONGUESPEECH DISORDERTONGUE PARALYSISTONIC/ CLONIC

CONVULSIONSTORTICOLLISTREMORTREMOR MUSCLEVISION BLURREDWEAKNESS GENERALIZEDHEPATITISRASH MACULO-PAPULARBULLOUS ERUPTIONHAEMORRHAGE NOSPRURITUSRASHRIGORSURTICARIATREMORRASH ERYTHEMATOUSNAUSEAPRURITUSRASHURTICARIADYSPNOEAFACE OEDEMAHEADACHETACHYCARDIAABDOMINAL PAINALKALOSIS METABOLICALLERGIC REACTIONANGIOEDEMAANOREXIAAV BLOCK SECOND

DEGREEBRONCHOSPASMCHILLSCOMACONVULSIVE DISORDERCOUGHING

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HYDROCHLOROTHIAZIDE - - - 1 1- 3 3 - 6- 1 - - 1- - - 1 1- - 2 - 2- 2 1 - 31 - - - 1- 1 1 - 21 1 1 - 32 - 3 - 51 - 1 - 21 4 1 - 6- 1 1 - 2- 1 - - 1- 1 - - 11 7 2 - 102 11 2 - 15- 1 - - 11 1 1 - 3- 1 - - 12 2 1 - 5- 2 - - 2- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 3 1 1 51 4 1 - 6

1 4 2 - 7- - 1 - 1

3 12 10 - 25- - 1 - 12 12 12 - 26- 9 9 - 18- 9 1 - 10- 1 2 - 3

- 1 - - 1- - 1 - 1- - 1 - 1

- - 1 - 1- - 1 - 1

DEBILITYDERMATITIS EXFOLIATIVEDERMATITIS LICHENOIDDIARRHOEADIZZINESSDYSPNOEAECZEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONHEADACHEHEPATITISHYPOCHLORAEMIAHYPOKALAEMIAHYPONATRAEMIAINSOMNIAMOUTH DRYMYALGIANAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPAINPALPITATIONPHOTOSENSITIVITY ALLERGIC

REACTIONPHOTOSENSITIVITY REACTIONPHOTOSENSITIVITY TOXIC

REACTIONPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESYNCOPETACHYCARDIATOXIC EPIDERMAL

NECROLYSISTHIRSTURINARY INCONTINENCE

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Spontaneous Report of Adverse Drug Reaction 2004 117

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE + AMILORIDE

HYDROCHLOROTHIAZIDE + TRIAMTERENE

HYDROCHLOROTHIAZISE + HYDRALAZINE HCL +RESERPINE

HYDROCORTISONEHYDROGEN PEROXIDE FOR TOPICAL

HYDROXYCARBAMIDE (HYDROXYUREA)HYDROXYCHLOROQUINE

HYDROXYZINE

2 5 2 - 9- 2 - - 2- - 1 - 12 2 1 1 6- 2 - - 2- - 1 - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 2 1 - 3- 6 6 - 12- 1 - - 1

- - 1 - 1- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 1- 2 - - 2

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - - 1 1- - - 1 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1

- 2 1 - 3- 1 - - 1- 2 - - 2- - 2 - 2- 1 - - 1- 2 1 - 3- - 1 - 1- 1 - - 1- 1 1 - 2- 1 1 - 2- 4 1 - 5- 5 3 - 8- - - 1 1- 1 2 - 3

URTICARIAVASCULITISVERTIGOVOMITINGEXTRAPYRAMIDAL DISORDERFATIGUEFIXED ERUPTIONHYPERPOTASSAEMIAHYPONATRAEMIAPRURITUSRASHSTEVENS JOHNSON

SYNDROMEURTICARIAFACE OEDEMAHYPOKALAEMIAHYPONATRAEMIAORAL ULCERATIONPHOTOSENSITIVITY

REACTIONSKIN DRYHYPERNATRAEMIANAUSEAVOMITINGCYANOSISDYSPNOEAVOMITINGRASHERYTHRODERMARASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEANGIOEDEMABRONCHITISDYSPNOEAFACE OEDEMAMYALGIAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULAR

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HYDROXYZINE

HYOSCINE-N-BUTYLBROMIDE

- 1 - - 1

- 1 - - 1

- 1 - - 1

1 1 1 - 3

- 4 - - 4

- 6 2 - 8

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 2 1 - 3

- 3 2 - 5

- 2 4 - 6

- - 1 - 1

- 1 1 - 2

1 3 2 - 6

- - 1 - 1

- 3 - - 3

- 1 1 - 2

- 3 - - 3

- 3 1 - 4

- - 1 - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- 1 1 - 2

- - 2 - 2

- 2 - 1 3

- 1 - - 1

- 9 2 - 11

- 2 5 - 7

- 11 8 - 19

1 21 18 2 42

1 12 9 - 22

- 10 2 - 12

- 1 - - 1

- 1 - - 1

- 2 - - 2

2 28 20 - 50

STEVENS JOHNSON

SYNDROME

URTICARIA

ANAESTHESIA MOUTH

ANAPHYLACTIC REACTION

ANAPHYLACTIC SHOCK

ANGIOEDEMA

ANOXIA

ANURIA

ASTHENIA

ASTHMA EXTRINSIC

BLOOD PRESSURE DROP

ARTERIAL

BRONCHOSPASM

DIZZINESS

DYSPNOEA

ECZEMA

ERYTHEMA

FACE OEDEMA

FATIGUE

FEVER

FIXED ERUPTION

FLUSHING

HOT FLUSHES

HYPOTENSION

INJECTION SITE

REACTION

MALAISE

MIGRAINE

MOUTH DRY

NAUSEA

OEDEMA

OEDEMA MOUTH

OEDEMA PERIORBITAL

PALPITATION

PRURITUS

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

SKIN EXFOLIATION

SYNCOPE

TACHYCARDIA

URTICARIA

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Spontaneous Report of Adverse Drug Reaction 2004 119

HYOSCINE-N-BUTYLBROMIDE

HYOSCINE-N-BUTYLBROMIDE + PARACETAMOL

HYOSCYAMINE

HYOSCYAMINE SULPHATE + ERGOTOXINE +BUTOBARBITONE

IBUPROFEN

- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 1 - 31 2 2 - 5- 12 2 - 14- 4 - - 4- 7 1 - 83 100 23 1 127- - 1 - 1- - 1 - 1- 2 2 - 4- 1 - - 1- 1 - - 1- 1 - - 1- 10 9 1 20- 4 1 - 5- 1 - - 1- - 1 - 1- 3 2 - 5- 1 - - 11 6 1 - 8- - 1 - 1- 2 5 - 7- 1 - - 1- 4 1 - 5- 2 - - 2- - 1 - 1- 5 1 - 6- - 2 - 2- - 1 - 1- 1 1 - 23 47 25 2 77- 1 - - 1

VISION ABNORMALVOMITINGWHEALSANGIOEDEMAURTICARIADYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSOEDEMA MOUTHPRURITUSRASHSTOMATITISANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAAPNOEAARTHRITISASTHMABRADYCARDIABRONCHITISBRONCHOPNEUMONIABRONCHOSPASMBULLOUS ERUPTIONBURNCELLULITISCHEILITISCHEMOSISCHEST PAINCHILLSCONJUNCTIVITISCOUGHINGDERMATITIS EXFOLIATIVEDIARRHOEADISORIENTATIONDIZZINESSDRUG ERUPTIONDYSPEPSIADYSPHONIADYSPNOEAECZEMA

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IBUPROFEN - 2 - - 2- - 1 - 1- 1 2 - 3- - 1 - 1- 8 5 - 13- - 1 - 1

- 1 - - 11 - - - 1- 1 - - 1- 1 - - 12 72 39 - 113- 4 2 - 6- 7 4 - 11- 7 5 - 121 - - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 -- - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 2 - - 2- 3 - - 3- 1 1 - 21 - 1 - 2- 10 2 - 12- - 1 - 12 21 11 - 341 5 2 - 8- 2 - - 2- 4 2 - 61 36 22 1 601 1 1 - 3

2 112 53 - 167- 3 1 - 4- 1 - - 1- - - - -- 1 - - 1- 6 3 - 9

EPIPHORAEPISTAXISERUPTIONERYTHEMAERYTHEMA MULTIFORMEEXTREMITIES HOT

FEELING OFEYE ABNORMALITYEYE IRRITATIONEYE PAINFACE MALFORMATIONFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLATULENCEGENITAL ULCERATIONGINGIVITISGUM HYPERPLASIAHEAD DISCOMFORTHEADACHEHOT DRY SKINHOT FLUSHESHYPOTENSIONHYPOTHYROIDISMLACRIMATION ABNORMALMOUTH DRYMOUTH ULCERATIONMYALGIANAUSEANERVOUSNESSOEDEMAOEDEMA GENERALISEDOEDEMA GENITALOEDEMA LEGSOEDEMA MOUTHOEDEMA OF

EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALORAL ULCERATIONOVERDOSE EFFECTPAIN IN FACEPALPITATION

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Spontaneous Report of Adverse Drug Reaction 2004 121

IBUPROFEN

IBUPROFEN + PARACETAMOL

- 1 - - 1- - 1 - 1

2 79 60 - 141- 1 1 - 22 85 76 1 1641 47 25 1 741 2 - - 3- - 1 - 11 35 24 - 60- 1 - - 1- 1 - - 1- 1 2 - 3- 1 - - 11 - - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 9 8 - 17

- 4 - - 4- - 1 - 1- 1 - - 1- 3 - - 3- 1 - - 1

- 2 2 - 4- - 1 - 1- - 1 - 1- - 1 - 1- 2 1 - 3

5 69 33 - 107- 1 - - 1- - 1 - 1- 1 - - 1- 9 4 1 14- 1 - - 1- 1 1 - 2- - 1 - 1- - - 1 1- 1 - 1 2

PERIODONTAL DESTRUCTIONPERIPHERAL NERVE

INJURYPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH FOLLICULARRASH HAEMORRHAGICRASH MACULO-PAPULARRASH PURPURICRENAL FAILURE ACUTERESPIRATORY DEPRESSIONRESPIRATORY DISTRESSRHINITISROSACEASHOCKSKIN EXFOLIATIONSLEEP DISORDERSODIUM RETENTIONSPUTUM INCREASEDST ELEVATEDSTEVENS JOHNSON

SYNDROMESTOMATITISSWEATING INCREASEDSWELLING AURICULARSYNCOPESYNDROME OF INAPP

ADH SECRETIONTACHYCARDIATHROMBOCYTOPENIATINNITUSTONGUE PARALYSISTOXIC EPIDERMAL

NECROLYSISURTICARIAVESICULAR RASHVISION ABNORMALVISION BLURREDVOMITINGWHEEZESANAPHYLAXISFACE OEDEMAOEDEMAOEDEMA LEGS

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IBUPROFEN + PARACETAMOL

IFOSFAMIDE

ILOPROST TROMETAMOL

IMIPENEM

IMIPENEM + CILASTATIN

- 1 - 1 2- 1 1 - 2- 2 1 1 4- - - 1 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 2 2 - 4- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 2 - 2- 1 - - 1- 1 1 - 2- - 2 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 2 1 - 3- - 1 - 1- - 1 - 1- - 1 - 1- 2 2 - 4- 3 1 1 5- 3 3 - 6- 7 10 - 17- 1 - - 1- 1 1 - 2

- 4 1 - 5- - 1 - 1- 1 1 - 2

OEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHDYSPNOEATREMORFLUSHINGPRURITUSRASHCHEILITISDERMATITIS EXFOLIATIVEDYSPNOEAFEVERFLUSHINGRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSEIZURE ANOXICURTICARIAANGIOEDEMABRONCHOSPASMCONVULSIONSDEATHDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEHEADACHEHEPATIC ENZYMES

INCREASEDMACULAR RASHNAUSEAOEDEMAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSEIZURE ANOXICSTEVENS JOHNSON

SYNDROMEURTICARIAVESICULAR RASHVOMITING

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Spontaneous Report of Adverse Drug Reaction 2004 123

IMIPRAMINE

IMMUNOGLOBULINS

INACTIVATED RABIES VACCINE VERO CELLS

INDAPAMIDE

INDINAVIR

- - 1 - 1- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- 1 - - 1- - - - -- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1

- 1 1 - 2- 2 1 - 3- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 5 2 - 7- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 2 1 - 3- 2 - - 2- 1 - - 1- - 1 - 11 4 5 - 10- 1 - - 11 2 1 - 4- 6 - - 6- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- 1 - - 1

AGITATIONDIZZINESSDROWSINESSINSOMNIANAUSEAPALPITATIONUNCONSCIOUSNESSCOUGHINGDYSPNOEAPRURITUSRASHBRONCHOSPASMINJECTION SITE

INFLAMMATIONPRURITUSRASHERYTHEMA MULTIFORMEFAINTNESSOEDEMA LEGSABDOMINAL PAINALOPECIABACK PAINCONSTIPATIONDIARRHOEADIZZINESSDRY LIPSDYSPNOEADYSURIAHAIR TEXTURE

ABNORMALHEADACHEHEMIMELIAHYPERLIPAEMIAHYPERTRIGLYCERIDAEMIAINSOMNIAJAUNDICELIPODYSTROPHYMOUTH DRYNAIL DISORDERNAUSEANUMBNESS LOCALIZEDORAL DRYNESSPAINPEPTIC ULCERPYURIA

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INDINAVIR

INDOMETHACIN

- 2 - - 2- 1 - - 1- 6 - - 6- 1 1 - 2- - 1 - 11 - - - 1- - 2 - 2- 8 2 - 10- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 8 1 - 9- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 4 1 - 5- 1 - - 11 2 - - 3- 3 - - 3- - 1 - 1- 1 - - 1- 4 - - 4- 1 - - 1- 3 1 - 4- - 1 - 1- 3 - 1 4- 11 3 - 14- 3 - - 3- - 1 - 1- 1 - - 1- 15 7 - 22- 9 6 - 15- 5 4 1 10- 7 1 - 8- 1 - - 1- 1 - - 1- 3 2 - 5

RASH MACULO-PAPULARRENAL COLICVOMITINGANAEMIAANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAARTHRITISASTHMABULLOUS ERUPTIONCHEST CONGESTIONCHEST PAINCONJUNCTIVITISCOUGHINGDERMATITISDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAECZEMAERUPTIONERYTHEMA MULTIFORMEEXTRAPYRAMIDAL DISORDERFACE OEDEMAFATIGUEFIXED ERUPTIONGASTRITISHOT FLUSHESHYPERTONIANAUSEANUMBNESS ORALOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPEPTIC ULCERPETECHIAEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRHINITISSTEVENS JOHNSON

SYNDROME

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Spontaneous Report of Adverse Drug Reaction 2004 125

INDOMETHACIN

INFLUENZA VACCINES

INFLUENZA VIRUS VACCINEPOLYVALENT (VAXIGRIP)

INSULIN HUMAN

INSULIN NPH

INSULINS

INSULINS, INTERMEDIATE-ACTING

INSULINS, INTERMEDIATE-ACTING,RAPIDONSET OF EFFECT

INSULINS, LONG-ACTING

INTERFERON BETA-1A

- 2 - - 2- 1 - - 1- 1 - - 1

- 7 4 - 11- 1 - - 1- 2 - - 2- - 1 - 1- 2 - - 2- 1 6 - 7- - 1 - 1- - 11 - 11- 1 - - 1- - 2 - 2- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1

- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- - 1 - 1- - 1 - 1- - 3 - 3- - 1 - 11 - - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- - 2 - 2- 1 - - 1- 1 3 - 4- - 1 - 1- - 1 - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 2 - 2- - 2 - 2- - 1 - 1- - 1 - 1

STOMATITISTACHYCARDIATOXIC EPIDERMAL

NECROLYSISURTICARIAVESICULAR RASHVISION ABNORMALVISION BLURREDVOMITINGFEVERHEADACHEINJECTION SITE PAINMYALGIAOEDEMAPAINRASH ERYTHEMATOUSHYPOGLYCAEMIAINJECTION SITE

REACTIONPRURITUSRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARHYPOGLYCAEMIAINJECTION SITE REACTIONRASH MACULO-PAPULARHYPOGLYCAEMIAPRURITUSHYPOGLYCAEMIAUNCONSCIOUSNESSFATIGUEPOLYDIPSIAPOLYURIADIZZINESSECCHYMOSISFATIGUEHYPOGLYCAEMIAINJECTION SITE PAINNAUSEAPALPITATIONRASHSHOCKVOMITINGFEVERHEPATITISMYALGIAOEDEMA LEGS

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IOBITRIDOL

IODINE FOR TOPICAL

IODINE PRODUCTSIODOCHLORHYDROXYQUIN + THYMOL + CATECHU

IOHEXOLIOPAMIDE

IOPAMIDOL

IOPANOIC ACIDIOPROMIDE (ULTRAVIST)

IOXITALAMIC ACID

IPRATROPIUM BROMIDE +FENOTEROL HYDROBROMIDE

IPRATROPIUM BROMIDE FOR INHALANT

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 4 1 - 5- 1 - - 11 2 - - 3- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 4 - - 4- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- 1 1 - 2- 2 - - 2- 1 1 - 2- - 1 - 1- 1 - - 1

COUGHINGNAUSEANEPHROPATHY NOSBURNVESICULAR RASHURTICARIADYSPNOEAPRURITUSRASH MACULO-PAPULARRASH ERYTHEMATOUSANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKBRONCHOSPASMDYSPNOEAURTICARIABRONCHOSPASMCOUGHINGDYSPNOEARASH MACULO-PAPULARDYSPNOEAEPIPHORAEYE IRRITATIONOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTONGUE DISORDERURTICARIAANAPHYLACTIC SHOCKDYSPNOEAOEDEMAOEDEMA PERIORBITALPRURITUSRASHURTICARIAVOMITINGCHEST PAINDYSPNOEAFEVERNAUSEAOEDEMA PERIORBITALPALPITATIONRASHRIGORSRASH

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Spontaneous Report of Adverse Drug Reaction 2004 127

IRBESARTAN AND DIURETICS

IRBESARTINISOAMINILE

ISONIAZID

- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

- 6 - - 6- 1 - - 11 - 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 1 1 - 3- 3 2 - 51 2 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- 3 2 - 5

- 1 - - 11 23 18 - 42- 1 - - 1- 1 - - 1- 2 1 - 3- 1 - - 1- 14 8 - 22- - 3 - 3- 3 - - 31 - - - 1- 1 -- - 12 2 3 - 7- 1 - - 1- - 1 - 1- 2 2 - 4- - 2 - 2- 2 - - 2

ABDOMINAL DISTRESSECZEMAPALPITATIONNEURONITISPERIANAL ITCHINGACNEANAEMIAANOREXIABULLOUS ERUPTIONCHEST PAINCHOLELITHIASISCHOLESTASIS INTRAHEPATICCREATININE BLOOD

INCREASEDDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAERYTHEMA MULTIFORMEERYTHROMELALGIAFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLATULENCEHEADACHEHEPATIC DISEASEHEPATIC ENZYMES

INCREASEDHEPATIC FAILUREHEPATITISHEPATITIS CHOLESTATICHEPATITIS INFECTIOUSHEPATOTOXIC EFFECTHYPERBILIRUBINAEMIAJAUNDICEJAUNDICE CHOLESTATICLIVER FUNCTION TESTS

ABNORMAL NOSMACULAR RASHMYALGIANAUSEANEURITISOEDEMAOEDEMA MOUTHOEDEMA PERIORBITAL

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ISONIAZID

ISOPROPAMIDE

ISOSORBIDE DINITRATE

ISOSORBIDE-5-MONONITRATE

ISOTRETINOINISOTRETINOIN+ERYTHROMYCIN

- 2 - - 2- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 12 16 12 - 303 15 15 - 332 6 4 - 121 13 3 - 17- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- - 2 - 2-- 4 4 - 8

- 1 - - 11 - - - 1- 1 - - 1- 8 2 - 10- 1 - - 12 3 2 - 7- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 1 - 2- 1 - - 1- 1 - - 11 10 2 - 13- 1 - - 1- 1 - - 1- 3 - - 3- 1 - - 11 1 - - 2- 1 - - 1- 1 - - 1- - 1 - 1

- 1 2 - 3- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 1 - 2- 2 - - 2- 1 - - 1

PAINPAPULOVESICULAR RASHPARAESTHESIAPERIPHERAL NEURITISPHARYNGITISPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSEIZURE ANOXICSEIZURES CEREBRALSGOT INCREASEDSKIN EXFOLIATIONSKIN NODULESTEVENS JOHNSON

SYNDROMESUFFOCATION FEELINGTHROMBOCYTOPENIATONGUE OEDEMAURTICARIAVISION ABNORMALVOMITINGDYSPNOEAPRURITUSRASHANAESTHESIA TONGUEDIZZINESSDYSPNOEAFATIGUEHEADACHENAUSEAPAINPALPITATIONPRURITUSRASHSWEATING INCREASEDTONGUE DISORDERTOXIC EPIDERMAL

NECROLYSISHEADACHEOEDEMA MOUTHRASHRASH MACULO-PAPULARSTOMATITISRASHDERMATITIS CONTACTHYPERPIGMENTATION SKIN

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Spontaneous Report of Adverse Drug Reaction 2004 129

ISRADIPINEITRACONAZOLE

JAPANESE ENCEPHALITIS VACCINE

KANAMYCIN

KETAMINE

KETOCONAZOLE

- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 2 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 3 2 - 5- 3 3 - 6- 1 1 - 2- - 3 - 3- 1 - - 1- 2 3 - 5- 1 - - 1- - 1 - 1

RASH MACULO-PAPULARHYPERLIPAEMIAHYPOKALAEMIAJAUNDICEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICURTICARIAANGIOEDEMAFEVERRASHURTICARIAPALPITATIONPRURITUSRASHRASH MACULO-PAPULARRETROBULBAR NEURITISHYPERTENSIONHYPERTONIANAUSEASPASMSTACHYCARDIATHROMBOPHLEBITISURTICARIAVOMITINGABDOMINAL PAINANAPHYLACTIC SHOCKANGIOEDEMAANOREXIABRONCHOSPASMCHEST PAINCHILLSDERMATITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAFACE OEDEMAFEVERFIXED ERUPTIONHEADACHEHEPATITISILL FEELING

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KETOCONAZOLE

KETOCONAZOLE FOR TOPICALKETOPROFEN

KETOTIFEN

LACTATE RINGER'S SOLUTION

LACTULOSELAMIVUDINE

- - 1 - 1- 1 - - 1- 2 2 - 4- 1 - - 1- 1 2 - 3- - 2 - 2- 9 4 - 13- 7 7 - 14- 1 - - 1- 4 4 - 8- 3 4 - 7- 1 - - 1- 1 - - 1- - 1 - 1- 3 - - 3- 1 1 - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- - 1 - 1- - 1 - 1- - 1 - 11 - 2 - 3- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 2 - 3- - 1 - 1

- 3 - - 3

MACULAR RASHMYALGIANAUSEAOEDEMA LEGSOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PSORIAFORMSKIN ULCERATIONTINNITUSURTICARIAVESICULAR RASHVOMITINGRASHDERMATITIS CONTACTOEDEMA MOUTHPRURITUSRASHCHEST PAINDYSPNOEAFACE OEDEMAOEDEMAPAPULAR RASHRASHRASH MACULO-PAPULARPRURITUSRASH ERYTHEMATOUSDIARRHOEAABDOMINAL PAINANAESTHESIA LIPANGIOEDEMADIZZINESSDYSPEPSIADYSPNOEAERYTHEMAFACE OEDEMAFATIGUEFEVERHEPATIC ENZYMES

INCREASEDHEPATITIS

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Spontaneous Report of Adverse Drug Reaction 2004 131

LAMIVUDINE

LAMIVUDINE + ZIDOVUDINE

LANSOPRAZOLE

LATANOPROST+TIMOLOL

LEFLUNOMIDELEUPRORELINLEVETIRACETAM

LEVOCETIRIZINELEVODOPA

LEVODOPA+BENSARAZIDE

LEVOFLOXACIN

1 - - - 1- 2 1 - 3- - 2 - 2- - 1 - 1- 1 3 - 4- 4 6 - 10- - 2 - 21 6 2 - 9- 1 - - 1- 3 - - 3

- 1 - - 1

- - 1 - 1- - 4 - 4- 4 - - 4- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 11 1 - - 21 - - - 1- 1 1 - 2- 1 3 - 4- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 1 - 2- - 1 - 1

INSOMNIAMYALGIANAUSEANEUROPATHYPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSKIN NODULESTEVENS JOHNSON

SYNDROMETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGANAEMIADYSPNOEAFATIGUEPALLORCHEST PAINPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIADRY EYESEYE ABNORMALITYPAINDERMATITIS EXFOLIATIVEPRURITUSRASHVERTIGOHEADACHENAUSEADIZZINESSDRY LIPSFATIGUENAUSEAPALPITATIONVOMITINGANGIOEDEMAARTHRITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPEPSIADYSPNOEAERYTHEMA MULTIFORME

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LEVOFLOXACIN

LEVOFLOXACIN EYES DROPLEVONORGESTREL + ETHINYLESTRADIOL

LEVOTHYROXINE SODIUMLIDOCAINE

- - 1 - 1- 1 2 - 3- - 1 - 1- - 2 - 2- - 1 - 1

- 2 3 - 5- 1 - - 1- 1 - - 1- 1 2 - 3- 5 10 - 15- 7 12 - 19- 5 5 - 10- 4 2 - 6- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 3 - 4- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 1 - - 1

FACE OEDEMAFATIGUEFEVERHEADACHEINJECTION SITE

REACTIONNAUSEAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSLEEP DISORDERSTOMATITISSYNCOPETACHYCARDIATREMORURTICARIAVOMITINGBLEPHARO CONJUNCTIVITISACNEURTICARIAURTICARIAANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISARRHYTHMIACHEST PAINCONJUNCTIVITISCONVULSIONSCONVULSIONS AGGRAVATEDDYSPNOEAFACE OEDEMAHEADACHEHYPOTENSIONNAUSEAOEDEMA GENERALISEDPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRESPIRATORY DEPRESSIONSEIZURES CEREBRAL

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Spontaneous Report of Adverse Drug Reaction 2004 133

LIDOCAINELIDOCAINE + VITAMIN B12

LIDOCAINE+EPINEPHRIN

LINCOMYCIN

LINEZOLIDLIQUID PARAFFIN

- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 1 1 - 3- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 2 - - 2- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 5 1 - 6- 8 6 - 14- 2 2 - 4- 3 3 - 6- 1 - - 1

- - 1 - 1- 1 - - 1- 1 - - 1

1 7 2 - 10- 2 - - 2- - 1 - 1- - 1 - 1

VOMITINGNAUSEAPALPITATIONPRURITUSRASH ERYTHEMATOUSVOMITINGDYSPNOEAHYPERTENSIONPALPITATIONURTICARIAABDOMINAL PAINANAESTHESIA MOUTHANAPHYLACTIC SHOCKANGIOEDEMABRONCHOSPASMCHEST PAINDEATHDIARRHOEADIZZINESSDYSPNOEAEAR NOISESERYTHEMA MULTIFORMEERYTHROCYTOSISFACE OEDEMAFEVERFIXED ERUPTIONFLUSHINGNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITISSYNCOPETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGRASH MACULO-PAPULARRASH MACULO-PAPULAR

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LITHIUM

LOPERAMIDE

LORATADINE

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- 4 3 - 71 - - - 1- 2 - - 2- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 2 2 - 4- 1 - - 1

- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 2 1 - 31 - - - 1- 1 - - 1- 2 - - 21 - - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 3 - - 3- 1 - - 1- 4 2 - 6- - 1 - 1- - 1 - 1- 3 1 - 4

ABDOMINAL PAINAGITATIONAKINESIAANOREXIAASTHENIAATAXIABRONCHOSPASMCONFUSIONDEPRESSIONDIARRHOEADIZZINESSDYSKINESIADYSPHAGIADYSTONIAEXTRAPYRAMIDAL

DISORDERFATIGUEHYPERTENSIONHYPONATRAEMIAMOUTH DRYMYALGIANAUSEAOEDEMA PERIPHERALPALPITATIONPOLYURIARASHSALIVA INCREASEDSINUS BRADYCARDIASOMNOLENCESYNCOPETREMORVOMITINGWALKING DIFFICULTYWEAKNESS GENERALIZEDCONJUNCTIVITISFACE OEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH MACULO-PAPULARURTICARIADYSPNOEAOEDEMA MOUTHPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 135

LORATADINE

LORATADINE + PSEUDOEPHEDRINE

LORAZEPAM

LOSARTAN

LOSARTAN PATASSIUM + HYDROCHLOROTHIAZIDE

LOVASTATINLOXOPROFEN

MAGESTO

MAGNESIUM CARBONATE (LAXATIVE)MAGNESIUM HYDROXIDEMAGNESIUM SULPHATE

- 1 1 - 2- 2 - - 2- 1 2 - 3- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 11 2 1 - 4- 1 1 - 2- - 1 - 1- 1 1 - 2- 1 - - 1- 2 - - 2- - 1 - 1- 1 2 - 3- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 3 - 4- 1 - - 1

- - 1 - 1- 2 - - 2- 2 - - 2- - 1 - 1- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1

RASHRASH ERYTHEMATOUSRASH MACULO-PAPULARFIXED ERUPTIONINSOMNIAPALPITATIONRASHURTICARIAANAPHYLACTIC SHOCKFACE OEDEMANAUSEAOEDEMAPALPITATIONPRURITUSRASHSWEATING INCREASEDURTICARIAVOMITINGCOUGHINGOEDEMA PERIPHERALPRURITUSURTICARIAASTHENIAAZOTEMIACOUGHINGDIZZINESSHYPOTENSION

ORTHOSTATICINSOMNIAPRURITUSRASHWEIGHT DECREASERASHANGIOEDEMAFACE OEDEMAMOUTH DRYOEDEMA PERIORBITALRASH ERYTHEMATOUSPRURITUSRASHURTICARIAURTICARIARASHPRURITUSRASHRASH ERYTHEMATOUSURTICARIA

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MALAYAN PIT VIPER-MONOVALENTSNAKE VENOM ANTISERUM

MANIDIPINE

MEBENDAZOLE

MECOBALAMIN

MEFENAMIC ACID

- - 1 - 1- - 1 - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1-- 2 - - 2- 1 - - 1- 1 1 - 2

- 1 1 - 2- - 1 - 1- - 1 - 1- - 1 - 1- - - 1 1- - 2 - 2- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- 2 2 - 4- 1 - - 1- 1 - - 1- 11 8 - 19- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 2 3 - 5- 1 - - 1- 1 - - 1- 9 2 - 11- 1 - - 1- 1 1 - 21 12 4 - 17- 1 - - 1- 2 5 - 7- 1 - - 1- - 1 - 1- 1 - - 1

CHEST PAINNUMBNESS ORALRASHDIZZINESSOEDEMAPRURITUSRASH MACULO-PAPULARANGIOEDEMAFACE OEDEMAPRURITUSRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMEURTICARIACHEILITISDERMATITISFEVERPALPITATIONURTICARIAACNEACNEIFORM DERMATITISANAESTHESIA MOUTHANAESTHESIA TONGUEANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMABLEPHARITISBRONCHOSPASMBULLOUS ERUPTIONCHEST CONGESTIONCHEST PAINDERMATITIS ECZEMATOIDDERMATITIS HERPETIFORMISDIARRHOEADIZZINESSDRUG ERUPTIONDYSPEPSIADYSPNOEAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONFLATULENCEGASTRITISHEADACHE

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Spontaneous Report of Adverse Drug Reaction 2004 137

MEFENAMIC ACID

MEGESTROLMEGLUMINE AMIDOTRIZOATE

- 1 - - 11 - - - 1- 1 - - 1- 6 2 - 8- 4 2 - 6- 1 1 - 2- 4 2 - 6- 8 1 1 10- 5 2 - 71 29 11 - 41- 1 - - 11 18 11 - 30- 1 - - 1- 10 3 - 13- 1 - - 1- 7 6 - 13- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 21 - - - 1

- - 1 - 1- 11 2 - 13- 6 2 - 8- 1 - - 1- 1 - - 1- 2 - - 2- 2 - - 2- 2 - - 2- - 1 - 1- 3 - - 3- 1 - - 1- 1 - - 1- 4 - - 4- 1 - - 1- 1 - - 1- 3 2 - 5- 4 3 - 7- 2 1 - 3- 8 7 - 15- 1 - - 1- - 1 - 1- 4 2 - 6- 4 - - 4

HYPERTONIAMACULAR RASHMOUTH DRYNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSPURPURARASHRASH ACNEIFORMRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PETECHIALSKIN EXFOLIATIONSTOMATITIS ULCERATIVESYNCOPETOXIC EPIDERMAL

NECROLYSISTREMORURTICARIAVOMITINGURTICARIAANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMABRONCHOSPASMDERMATITIS ALLERGICDYSPNOEAECZEMAHYPOTENSIONNAUSEAPALPITATIONPAPULAR RASHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PUSTULARRIGORSURTICARIAVOMITING

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MEGLUMINE AMIDOTRIZOATE + SODIUMAMIDOTRIZOATE

MEGLUMINE IOTHALAMATE

MEGLUMINE IOXITALAMATE

MEGLUMINE IOXITALAMATE + SODIUM IOXITALAMATE

1 - - - 1- 1 - - 1- - 1 - 1- 9 5 - 141 3 3 - 7- 1 - - 1- 1 - - 1- 1 2 - 3- 2 1 - 3- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 3 - - 3- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 1- 5 2 - 7- 1 - - 1

- 2 1 - 3- 2 1 - 3- 1 - - 1- 6 2 - 8- 2 - - 2- 1 - - 1- 2 1 - 3- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

DYSPNOEAFLUSHINGNUMBNESSPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSNEEZING EXCESSIVEURTICARIAWHEALSCOUGHINGDYSPNOEAHYPOTENSIONNAUSEAPARAESTHESIAPRURITUSRASHVISION BLURREDVOMITINGABDOMINAL PAINANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONCHEST PAINCHILLSDIZZINESSDYSPNOEAFACE OEDEMANAUSEAOEDEMA PERIORBITALPAPULAR RASHPRURITUSPULSE RATE

INCREASEDRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGANAPHYLACTIC REACTIONANAPHYLACTOID REACTIONANAPHYLAXISDYSPNOEAEYE IRRITATIONFACE OEDEMAFLUSHINGPALPITATION

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Spontaneous Report of Adverse Drug Reaction 2004 139

MEGLUMINE IOXITALAMATE + SODIUM IOXITALAMATE

MELOXICAM

MEPIVACAINEMERCAPTOPURINE

MEROPENEM

- 2 - - 2- 2 - - 2- - 1 - 1- 1 - - 1- 2 - - 2- 3 - - 3- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 11 - - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 3 - 4- - 1 - 1- - 1 - 1- - 1 - 1- - 3 - 3- 1 2 - 3- - 2 - 21 2 - - 31 - 2 - 3- - 1 - 1

- 1 2 - 3- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- - - 1 1- - - 1 1- 1 - - 1- - - 1 1- - - 1 1- 2 - - 2- 7 2 - 9- 5 3 - 8- 3 5 - 8

PRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSHOCKURTICARIAVOMITINGWHEALSABDOMINAL PAINACNEIFORM DERMATITISANGIOEDEMAASTHENIAAZOTEMIADIZZINESSEYE ABNORMALITYEYE IRRITATIONGASTRIC ULCER

HAEMORRHAGICGASTRITISNAUSEANEUROPATHY PERIPHERALNUMBNESSOEDEMA LEGSOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEVOMITINGWEIGHT DECREASEANAPHYLAXISANOREXIAFEVEROLIGURIARASH MACULO-PAPULARSKIN EXFOLIATIONSTOMATITISURTICARIADIARRHOEAFEVERPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULAR

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MEROPENEMMETAMIZOLE (DIPYRONE)

METAMIZOLE SODIUM + LIDOCAINE HYDROCHLORIDE

METAMIZOLE SODIUM + PARACETAMOL

- - 1 - 1- 6 4 - 10- 1 - - 11 7 2 - 101 3 2 - 6- 1 - - 1- - 1 - 1- 6 4 - 10- - 1 - 1- 1 - - 1- 3 2 - 5- 2 2 - 41 3 2 - 6- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 1 - 3- 1 - - 1- - 1 - 1- 3 - - 3- 1 5 - 6- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 6 5 - 11- 1 - - 1- 10 12 - 22- 3 5 - 8- 1 - - 1- 7 3 - 10- 1 1 - 2

- 1 - - 1- - 2 - 2- 1 - - 1- - 1 - 1

- 6 5 - 11- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 1- - 1 - 1

URTICARIAANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONBURNDYSPNOEAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONGINGIVAL BLEEDINGHYPOTENSIONMACULAR RASHMYALGIANAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALORAL ULCERATIONPAINPALPITATIONPARAESTHESIAPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESWEATING INCREASEDSYNCOPETHROAT TIGHTNESSTOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGDYSPNOEAOEDEMA PERIORBITALPRURITUSRASHURTICARIABREAST PAIN FEMALE

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Spontaneous Report of Adverse Drug Reaction 2004 141

METAMIZOLE SODIUM + PARACETAMOL

METFORMIN

METHADONE

METHIMAZOLE (THIAMAZOLE)

- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 11 1 - - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 4 - 5- 2 - - 2- 1 1 - 2- - 1 - 1- - 1 - 11 - 2 - 3- 1 1 - 2- 1 - - 1- 1 - - 11 2 2 - 5- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 13 5 2 - 10- 1 - - 11 - 1 - 2- 2 1 - 3- 6 4 - 10- 2 - - 2- 3 1 - 4- - 1 - 1- 1 - - 11 3 1 - 5- 1 - - 13 3 3 - 9- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- - 2 - 2- - 1 - 1- - 1 - 1

- 1 - - 1

BULLOUS ERUPTIONPRURITUSRASH ERYTHEMATOUSABDOMINAL PAINACIDOSIS METABOLICANGIOEDEMAANOREXIABULLOUS ERUPTIONCHILLSDERMATITIS CONTACTDIARRHOEADIZZINESSDYSPNOEAERYTHEMA MULTIFORMEEXTRAPYRAMIDAL DISORDERFATIGUEFLATULENCEHEADACHEHYPERPIGMENTATION SKINHYPOGLYCAEMIAMOUTH DRYMUCOSA VESICLEMUSCLE WEAKNESSMYALGIANAUSEAOEDEMAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTOMATITISSYNCOPEURTICARIAVERTIGOVOMITINGWEAKNESS GENERALIZEDCOMARESPIRATORY ARRESTANAPHYLACTIC SHOCKANGIOEDEMAHEPATITISOEDEMA MOUTHPERIPHERAL SENSORY

NEUROPATHYPRURITUS

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METHIMAZOLE (THIAMAZOLE)

METHOCARBAMOLMETHOTREXATE

METHOXSALENMETHYLDOPA

METHYLENE BLUE + HEXAMINE +POTASSIUM NITRATE

- - 1 - 1- 2 - - 2- - 1 - 1- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 1 - 2- - 1 - 1- - - 1 1- 1 - - 1- 1 - - 1- 2 - - 2

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- - - 1 1- - - 1 1- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

RASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAURTICARIAANGIOEDEMADYSPNOEAGASTRITISGINGIVITISGLOSSITISHEPATITISMUCOSITIS NOSNEUTROPENIAOEDEMA PERIORBITALORAL ULCERATIONPANCYTOPENIAPHOTOSENSITIVITY REACTIONPHOTOSENSITIVITY TOXIC

REACTIONRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTESKIN EXFOLIATIONSTOMATITISURTICARIADERMATITISANGIOEDEMADIZZINESSDROWSINESSDYSPNOEAFACE OEDEMAFEVERHEADACHEMOUTH DRYMUSCLE WEAKNESSMYALGIANAUSEAOEDEMA PERIORBITALPAIN LEGSPALPITATIONPRURITUSRASHTHIRSTDYSPNOEAOEDEMARASH ERYTHEMATOUS

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Spontaneous Report of Adverse Drug Reaction 2004 143

METHYLENE BLUE + HEXAMINE +POTASSIUM NITRATE

METHYLENE BLUE

METHYLERGOMETRINE

METHYLPHENIDATE

METHYLPREDNISOLONE

METHYLSALICYLATE

METHYLSCOPOLAMINEMETHYLTESTOSTERONEMETHYSERGIDEMETOCLOPRAMIDE

- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 11 58 - 69- 1 - - 1- - 1 - 1- - 3 - 31 1 9 - 11- 1 - - 1- - 8 - 8- - 2 - 2- 1 4 - 5- - 4 - 41 1 - - 2- - - - -- - 4 - 4- - 1 - 1- - 1 - 1- 1 14 - 15- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 3 1 - 41 1 - - 2- 2 - - 2- 26 3 - 29- 1 - - 1

URTICARIA

BRONCHOSPASMNAUSEASTOMATITIS NECROTISINGVOMITINGPRURITUSRASHRASH ERYTHEMATOUSURTICARIAABDOMINAL PAINAGGRESSIVE REACTIONANOREXIADEPRESSIONDIZZINESSGROWTH RETARDEDHEADACHEHYPERACTIVITYINSOMNIAIRRITABILITYNAUSEAPALPITATIONSOMNOLENCESPEECH DISORDERTICSURTICARIAVOMITINGWEIGHT DECREASEOEDEMA PERIORBITALPRURITUSURTICARIABURNING SKINRASH MACULO-PAPULARAGITATIONJAUNDICERASHAGITATIONANAESTHESIA LOCALANAPHYLACTIC SHOCKBRONCHOSPASMDIZZINESSDYSPNOEADYSTONIAEPILEPSYEXTRAPYRAMIDAL DISORDERFATIGUE

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METOCLOPRAMIDE

METOPROLOL

METRIZAMIDEMETRONIDAZOLE

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 2 - - 2- 1 - 1 2- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 3 - 1 4- 3 1 - 4- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 3 1 - 4- 2 - - 2- 1 - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 1 - 2- 1 - - 1- 1 1 - 2- 1 - - 1- 1 1 - 21 - - - 1- 1 - - 1- 1 - - 12 - - - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 3 2 - 5- 1 - - 1- 1 - - 1

FEVERFIXED ERUPTIONINJECTION SITE PAINJAW MALFORMATIONJAW STIFFNESSLOCKJAWMENINGISMUSMOUTH DRYNECK TIGHTNESSOEDEMAPAINPALPITATIONPARKINSONISMPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATION LABOREDSALIVA INCREASEDSINUS TACHYCARDIASPASMSSTOMATITISTACHYCARDIATONGUE PARALYSISURTICARIABRADYCARDIADIZZINESSDYSPNOEAECZEMAFACE OEDEMAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSINUSITISURTICARIAVERTIGORASH ERYTHEMATOUSABDOMINAL DISCOMFORTABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMAANOREXIAAPNOEA

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Spontaneous Report of Adverse Drug Reaction 2004 145

METRONIDAZOLE - 1 - - 1

- 3 - - 3- - 1 - 1- - 1 - 1- 2 - - 21 4 5 - 101 - - - 1- 4 4 - 81 - - - 1- 1 - - 11 - 1 - 2- 1 1 - 2- - 2 - 2- 2 3 - 5- 1 - - 1- 2 2 - 4- 1 - - 1- - 1 - 11 - - - 1- 1 - - 11 7 6 - 14- 2 2 - 41 - - - 1- 1 - - 1- - 1 - 1- 3 5 - 8- - 4 - 41 4 4 - 9- 1 - - 13 17 13 - 343 16 18 1 381 15 7 - 231 14 11 - 26- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 1 - 2- 1 1 - 2

- 1 - - 1- - 1 - 1

BONE MARROWDEPRESSION

BRONCHOSPASMBULLOUS ERUPTIONCHILLSDIARRHOEADIZZINESSDYSKINESIA TARDIVEDYSPNOEAERUCTATIONERYTHEMAERYTHEMA MULTIFORMEFATIGUEFEVERFIXED ERUPTIONFLATULENCEHEADACHEHOT FLUSHESINSOMNIAMOUTH DRYMYALGIANAUSEAOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARRESPIRATORY DISORDERSKIN DISCOLOURATIONSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS

ULCERATIVETACHYCARDIATASTE BITTER

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METRONIDAZOLE

MIANSERIN

MICONAZOLE

MICROPARTICLES OF GALACTOSEMIDAZOLAM

MIDECAMYCIN

MINOXIDIL

MIRTAZAPINE

MISOPROSTOL

- 1 - - 1- 2 - - 2- 1 - - 1

- 1 - - 1- - 1 - 11 13 18 - 32- - 1 - 1- 5 5 - 10- - 1 - 1-- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1

- - 1 - 1- - 1 - 11 - - - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 2 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 3 - 4- 2 - - 2- 1 - - 1- 1 - - 1- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - - -- - 1 - 1- 1 - - 1

TASTE PERVERSIONTONGUE ULCERATIONTOXIC EPIDERMAL

NECROLYSISTREMORURINE ABNORMALURTICARIAVARICOSE ECZEMAVOMITINGCONFUSIONHYPERKINESIALEG PAINOEDEMAPALPITATIONSTEVENS JOHNSON

SYNDROMESWEATING INCREASEDTHROAT DRYAPPLICATION SITE

REACTIONRASHHYPOTENSIONPHLEBITISRASH ERYTHEMATOUSURTICARIABURNDERMATITIS EXFOLIATIVEDYSPHAGIAFACE OEDEMAFEVEROEDEMAPRURITUSRASHRASH ERYTHEMATOUSSKIN ULCERATIONSTOMATITISURTICARIAFACE OEDEMATACHYCARDIACONSTIPATIONDIZZINESSDROWSINESSSOMNOLENCEABDOMINAL PAINABORTIONOEDEMA PERIORBITAL

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Spontaneous Report of Adverse Drug Reaction 2004 147

MISOPROSTOL

MIST. SCILLAE AMMON

MIST. TUSSIS + AMMONIUM CARBONATE

MITOMYCINMITOXANTRONE

MIXTURE CARMINATIVE

MIXTURE TUSSIS (BROWN MIXTURE)

MIZOLASTINE

MMR (MUMPS + MEASLES + RUBELLA)

MONOETHANOLAMINE OLEATE

MONTELUKAST

MORBILLI (MEASLES)MORPHINE

- 1 - - 1- 1 - - 1- 1 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 2 - 2- - 1 - 1- - 2 - 2- 1 - - 1- - 1 - 1- 1 1 - 2- 2 - - 2- 1 - - 1- 1 - - 1- 2 2 - 4- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 2 - - 2- - 3 - 3- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1

- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - - - 1

PRURITUSRIGORSVAGINAL HAEMORRHAGECHEST PAINDYSPNOEAURTICARIAWHEEZESPRURITUSRASHRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARAGITATIONBRONCHOSPASMDYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAANGIOEDEMADYSPNOEAECZEMAFACE OEDEMAOEDEMA LEGSOEDEMA PERIORBITALPALPITATIONRASHRASH ERYTHEMATOUSURTICARIASOMNOLENCETHIRSTCHILLSFEARFEVERURTICARIAAPPLICATION SITE

REACTIONRASH ERYTHEMATOUSCONVULSIONSDEPRESSIONFATIGUEFEVERHYPERTONIAWEAKNESS GENERALIZEDURTICARIAANAPHYLACTIC SHOCK

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MORPHINE

MOXIFLOXACIN

MUCOPOLYSACCHARIDE + SALICYLIC ACID +SUPRARENAL EXTR.

MULTIVITAMINS

- 1 - - 11 2 - - 3- 1 - - 1

- 1 - - 1- 1 - - 1- 1 1 - 21 2 - - 3- 1 - - 1- - 1 - 1- 1 - - 1- 3 - - 3

- 1 1 - 21 1 - - 2- - 1 - 1- 9 - - 9- 8 2 - 10- 5 - - 51 2 1 - 4- 1 - - 1- 5 1 - 6- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1

ANEURYSMANGIOEDEMABLOOD PRESSURE

DROP ARTERIALBRONCHOSPASMCONSTIPATIONDIZZINESSDYSPNOEAFATIGUEFLUSHINGHYPOTENSIONINJECTION SITE

REACTIONNAUSEAPALPITATIONPHLEBITISPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY DEPRESSIONURTICARIAVOMITINGARTHRALGIAASTHENIADIZZINESSDYSPNOEAHYPERACIDITYINSOMNIAMALAISEMYALGIANAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSTACHYCARDIAURTICARIAVOMITINGBURNING SKINDERMATITIS CONTACTPRURITUSBULLOUS ERUPTIONDIZZINESSFACE OEDEMAFATIGUE

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Spontaneous Report of Adverse Drug Reaction 2004 149

MULTIVITAMINS

MULTIVITAMINS AND IRON

MULTIVITAMINS WITH MINERALS

NABUMETONE

NADROPARIN CALCIUMNADROPARIN SODIUMNAPROXEN

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - 1 2- - 1 - 1- 1 - - 1

- 1 - - 1- - 1 - 1

1 1 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 1 - 3- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 6 4 - 10- - 2 - 2- 1 1 - 2- - - 1 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 1- 3 3 - 6

FIXED ERUPTIONFLUSHINGHEADACHENAUSEAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMESYNCOPETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGOEDEMA MOUTHOEDEMA PERIORBITALRASHRASH BULLOUSRASH MACULO-PAPULARDIZZINESSFIXED ERUPTIONMOUTH DRYNAUSEAPALPITATIONPAPULAR RASHPHOTOSENSITIVITY REACTIONPRURITUSRASHTONGUE PARALYSISVOMITINGENDOMETRIAL BLEEDINGPURPURAANAEMIAANAESTHESIA MOUTHANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMAAPNOEACHEST PAINCONJUNCTIVITISCONSTIPATIONDERMATITIS EXFOLIATIVEDIZZINESSDYSPHASIADYSPNOEA

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NAPROXEN

NAPROXEN SODIUM

NEBIVOLOL

- 1 - - 11 7 3 - 111 - - - 1- - 1 - 1

- 1 - - 1

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 1 - 3- 7 1 - 81 4 - - 5- 1 1 - 2- - 1 - 11 - - - 1- 10 8 - 18- 11 9 - 20- 3 1 - 4- 2 2 - 4- - 1 - 1

- - 1 - 1- - 1 - 1- 3 - - 3- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 1 - 2- 1 - - 1- - - 1 1- 2 3 1 6- 3 - - 3- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- - 1 - 1

EYE IRRITATIONFACE OEDEMAFIXED ERUPTIONGASTRIC ULCER

HAEMORRHAGICGASTRITIS

HAEMORRHAGICHYPOTHYROIDISMHYPOVOLAEMIAMELAENANAUSEAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPEPTIC ULCERPETECHIAEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITIS ULCERATIVETHROAT DRYURTICARIAVASCULITISVISION ABNORMALVISION BLURREDVOMITINGABDOMINAL PAINANGIOEDEMABRONCHOSPASMFACE OEDEMAOEDEMA DEPENDENTOEDEMA PERIORBITALPRURITUSRASHRASH FOLLICULARRASH MACULO-PAPULARURTICARIACONSTIPATIONSOMNOLENCESYNCOPE

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Spontaneous Report of Adverse Drug Reaction 2004 151

NELFINAVIR

NEOMYCIN

NEOMYCIN + FURAZOLIDONE +DIIODOHYDROXYQUINOLINE +SUCCINYLSULFATHIAZOLE

NEOMYCIN + POLYMYCIN B FOR OPHTHAL

NEOMYCIN + POLYMYXIN B + FLUDROCORTISONE +LIDOCAINE (FOR OTOLOGICAL)

NEOMYCIN + POLYMYXIN B +GRAMICIDIN FOR OPHTHAL

NETILMICIN

NEVIRAPINE

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 1 - 2- 1 - - 1

- 1 - - 1

- 2 - - 2- 1 - - 1- 1 1 - 21 - - - 1- 1 - - 1- 1 - - 11 2 - - 3- 1 - - 1- 2 1 - 3- 1 2 - 3- 6 - - 6- 1 - - 11 - - - 1

- 7 3 - 10- 1 - - 1- 3 - - 3- 1 - - 11 1 - - 2- - 1 - 1

1 - - - 1

DERMATITISDIARRHOEADIZZINESSRASH ERYTHEMATOUSBURNING MUCOSALOEDEMA MOUTHRASH MACULO-PAPULAROEDEMA PERIORBITALRASH ERYTHEMATOUSRASH MACULO-PAPULAREYE IRRITATIONOEDEMA PERIORBITALPAINRASH PUSTULAR

OEDEMA PERIORBITALPRURITUSRASHRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTERENAL FUNCTION

ABNORMALSTEVENS JOHNSON

SYNDROMEURTICARIAABDOMINAL PAINANGIOEDEMABULLOUS ERUPTIONCONJUNCTIVITISCOUGHINGDERMATITIS EXFOLIATIVEDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFIXED ERUPTIONHEPATIC FUNCTION

ABNORMALHEPATITISHEPATOMEGALYHEPATOTOXIC EFFECTINSOMNIAJAUNDICEJAUNDICE CHOLESTATICJOINT PAIN

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NEVIRAPINE

NICARDIPINE HYDROCHLORIDE

NICLOSAMIDE

NICLOSAMIDE + PHENOLPHTHALEIN

NICOTINIC ACID

- - 1 - 1-- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 6 1 - 72 14 12 - 28- 8 4 - 121 22 5 - 28- - 1 - 1- 1 - - 14 4 1 - 9

- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 11 - - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- 3 - - 3- 1 - - 1- - 1 - 1

- 2 - - 2

LIPODYSTROPHYMOUTH ULCERATIONMYALGIAMYOPATHYOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSKIN DRYSKIN FLUSHEDSTEVENS JOHNSON

SYNDROMESTOMATITISTHROAT SOREURTICARIAVASCULITISVOMITINGOEDEMA PERIORBITALRASH MACULO-PAPULARABDOMINAL PAINANAPHYLACTIC SHOCKCONJUNCTIVITISPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVESICULAR RASHCHEILITISPRURITUSRASHRASH MACULO-PAPULARHOT FLUSHESPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRESPIRATORY DEPRESSIONSTEVENS JOHNSON

SYNDROMEURTICARIA

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Spontaneous Report of Adverse Drug Reaction 2004 153

NIFEDIPINE

NIFUROXAZIDE

NIMESULIDE

- 4 - - 4- 1 - - 11 - - - 1- 1 - - 1- 9 - - 9-- 2 1 - 3- 1 - - 1- 4 1 - 5- 3 2 - 5- 1 - - 1- 5 - - 5- 1 - - 1- 1 - - 1- 4 2 - 6- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- 3 1 - 4- 1 1 - 2- - 1 - 1- 6 1 - 7- 1 1 - 2- 6 - - 61 3 1 1 6- 7 2 - 9- - 6 - 6- - 2 - 2

- 1 - - 1- 1 1 - 2- - 1 - 1- 1 1 - 2- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 2 - - 2-- 1 1 - 2- 3 1 - 4- 2 - - 2- 1 - - 1

ANGIOEDEMAARRHYTHMIAARTHRITISCOUGHINGDIZZINESSDYSPNOEAERYTHROMELALGIAFACE OEDEMAFATIGUEFIXED ERUPTIONFLUSHINGGINGIVA HYPERTROPHIAGINGIVAL HYPERTROPHYHEADACHEMACULAR RASHMOUTH DRYMUSCLE CRAMPMYALGIANAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA LEGSOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITIS ULCERATIVETACHYCARDIATINNITUSURTICARIAVISION ABNORMALVOMITINGWEAKNESS GENERALIZEDDYSPNOEAFACE OEDEMAPRURITUSRASH MACULO-PAPULARURTICARIAABDOMINAL PAINANGIOEDEMABRONCHOSPASMCONFUSION

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NIMESULIDE

NIMODIPINENITRENDIPINENITROGLYCERINENORELGESTROMIN AND ESTROGEN

NORETHISTERONE

NORFLOXACIN

- 1 2 - 3- 1 - - 1- 9 1 - 10- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 7 2 - 9- 2 2 - 4- 1 - - 1- 1 - - 1- 3 5 - 8- 1 - - 1- - 1 - 1- - 1 - 1- 5 2 - 7- 5 1 - 6- 2 1 - 3- 1 1 - 2- 2 1 - 3- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 3 - 3- - 1 - 1

- - 1 - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 1 1 - 3- 3 - - 3- 2 - - 21 11 4 - 16- 8 - - 8- - 1 - 1

DYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFIXED ERUPTIONGASTRO-INTESTINAL

DISORDER NOSHEPATITISHOT DRY SKINJAUNDICEMEASLY RASHNAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPAPULAR RASHPRURITUSRASHRASH ERYTHEMATOUSSTOMATITISURTICARIAVERTIGOVOMITINGRASH MACULO-PAPULARFATIGUEHEADACHEBREAST ENGORGEMENTINJECTION SITE

BLEEDINGNAUSEAPRURITUSRASH ERYTHEMATOUSEMOTIONAL LABILITYHOT FLUSHESINSOMNIARASH MACULO-PAPULARABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTION

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Spontaneous Report of Adverse Drug Reaction 2004 155

NORFLOXACIN - - 1 - 1- - 1 - 11 2 1 - 4- 1 - - 1- 2 1 - 31 11 5 - 17- 1 - - 1- 1 - - 1- 7 3 - 10- - 1 - 1- - 1 - 11 3 2 - 6- 1 2 - 3- 2 1 - 3- - 1 - 1- - 1 - 1- 4 4 - 8- 5 2 - 7- 1 - - 1- 7 3 - 10- 4 3 - 7- - 1 - 1- 4 2 - 6- 2 - - 21 41 19 2 63- - 1 - 11 51 34 1 88- - 1 - 1- 31 12 1 44- 2 - - 24 32 14 - 51- 1 - - 1-- - 3 - 3- 1 - - 1

- 1 - - 1- 4 - - 4

1 2 1 - 4- - 1 - 1- 1 - - 1

- 1 - - 1- - 1 - 1

BURNING MUCOSALCHEILITISCHEST PAINDIARRHOEADIZZINESSDYSPNOEAERUPTIONERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGHEADACHEHYPOTENSIONMOUTH ULCERATIONNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPARAESTHESIAPRURITUSPRURITUS GENITALRASHRASH ACNEIFORMRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARRESPIRATORY

DEPRESSIONSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVESWELLING

NON- INFLAMMATORYTACHYCARDIATONGUE OEDEMA

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NORFLOXACIN

NORGESTREL AND ESTROGEN

NORTRIPTYLINE

NYSTATIN + DIIODOHYDROXYQUINOLINE +BENZALKONIUM CHLORIDE (GYNECOLOGICAL)

OFLOXACIN

1 34 19 1 55- 1 - - 1- 1 - - 1- 1 - - 1- 4 2 - 6- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - - 1 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 - - 2- 1 6 - 7- 5 1 - 6- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - - 1 1- - - 1 1

URTICARIAVESICULAR RASHVISION ABNORMALVISION BLURREDVOMITINGHOT FLUSHESOEDEMA GENERALISEDPALPITATIONRASH MACULO-PAPULARARRHYTHMIADYSPNOEAFACE OEDEMAFATIGUEPALPITATIONRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESWEATING INCREASEDURINARY RETENTIONURTICARIAERYTHEMA MULTIFORMEUTERINE HAEMORRHAGEVAGINITISABDOMINAL DISCOMFORTABDOMINAL DISTRESSABDOMINAL PAINACNEIFORM DERMATITISANAPHYLACTIC REACTIONANAPHYLAXISANGIOEDEMAARTHRITISBRONCHOSPASMBURNING SKINCHEILITISCHEST PAINCRYING ABNORMALDIARRHOEADIZZINESSDYSPNOEAERUPTIONERYTHEMAERYTHEMA MULTIFORMEEYE ABNORMALITYEYE BURNSEYE PAIN

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Spontaneous Report of Adverse Drug Reaction 2004 157

OFLOXACIN

OLANZAPINE

OMEPRAZOLE

- 2 1 - 3- - 1 - 1- 1 1 - 2- 2 1 - 3- - 1 - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 1 1 - 2- 7 5 - 12- 1 2 - 3- - 1 - 1- 2 2 - 4- 1 2 - 3- 1 - - 1- 1 3 - 4- 1 - - 1- 9 11 - 20- 21 12 - 33- 6 7 - 131 9 1 - 11- - 1 - 1- 4 4 - 8

- 1 2 - 3- 2 - - 2- 1 - - 1- 6 5 - 11- - 1 - 1- 1 - - 1- 7 5 - 12- 1 - - 1- 3 8 - 11- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 3 1 - 5- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

FACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLATULENCEGLOSSITISHEADACHEHEPATITISINSOMNIANAUSEAOEDEMAOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALPAINPALPITATIONPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSKIN ULCERATIONSTEVENS JOHNSON

SYNDROMESTOMATITISTACHYCARDIATASTE PERVERSIONURTICARIAURTICARIA ACUTEVERTIGOVOMITINGFACE OEDEMAFEVERNEURALGIAOEDEMA GENERALISEDABDOMINAL PAINABRASION NOSANAPHYLACTIC SHOCKANOREXIABRONCHOSPASMBULLOUS ERUPTIONDERMATITIS EXFOLIATIVEDIARRHOEADYSPHONIAERYTHEMA

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OMEPRAZOLE

ONDANSETRON

OPV (ORAL POLIO VACCINE)

ORAL CONTRACEPTIVE PILL

ORAL REHYDRATION SALT (ORS)

ORLISTAT

ORPHENADRINE CHLORIDE

- 1 - - 1

- 1 1 - 2

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 2 - - 2

- 2 - - 2

- - 1 - 1

- 1 - - 1

1 - - - 1

- - 1 - 1

1 6 7 - 14

- 1 - - 1

1 10 10 - 21

- 4 1 - 5

- 7 2 - 9

- - 1 - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- 5 4 - 9

- 1 - - 1

- 1 1 - 2

- - 1 2 3

- 1 - - 1

- - 1 - 1

- 1 1 2 4

- 1 - - 1

- 1 - - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

ERYTHEMA MULTIFORME

FEVER

HEADACHE

HYPOTENSION

INSOMNIA

NAUSEA

OEDEMA

OEDEMA PERIORBITAL

PALPITATION

PAPULOVESICULAR RASH

PETECHIAE

PHARYNGITIS

PRURITUS

PRURITUS GENITAL

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

RIGORS

STEVENS JOHNSON

SYNDROME

STOMATITIS

TOXIC EPIDERMAL

NECROLYSIS

URTICARIA

VERTIGO

VOMITING

INJECTION SITE

INFLAMMATION

INJECTION SITE PAIN

INJECTION SITE REACTION

RASH

RASH ERYTHEMATOUS

THROAT DRY

FEVER

RASH

VOMITING

RASH

FIXED ERUPTION

RASH MACULO-PAPULAR

MYALGIA

ABDOMINAL PAIN

ANAPHYLACTIC SHOCK

CHEST PAIN

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Spontaneous Report of Adverse Drug Reaction 2004 159

ORPHENADRINE CHLORIDE

ORPHENADRINE CITRATE

OXALIPLATIN

OXCARBAZEPINE

OXYMETHOLONE

CONFUSIONDERMATITIS EXFOLIATIVEDIZZINESSLIP ULCERATIONMOUTH DRYPRURITUSRASHURTICARIAVERTIGOABDOMINAL PAINAGITATIONANAESTHESIA LOCALANAESTHESIA MOUTHATAXIACHEST PAINDIZZINESSDROWSINESSDYSPNOEAFIXED ERUPTIONMOUTH DRYMUSCLE WEAKNESSNAUSEAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSSOMNOLENCESTEVENS JOHNSON

SYNDROMETONGUE PARALYSISURTICARIAVISION BLURREDVOMITINGDYSPNOEAOEDEMA MOUTHRASH ERYTHEMATOUSACNEIFORM DERMATITISDIZZINESSPRURITUSRASHRASH ERYTHEMATOUSVOMITINGBILIRUBIN INCREASEDCIRRHOSIS BILIARY

- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 2 - - 2- 1 - - 1- 1 - 1 2- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 1

- 1 - - 1- 2 1 - 3- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 3 - - 3- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1

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OXYMETHOLONEOXYPHENCYCLIMINE

OXYTETRACYCLINE

OXYTOCIN

PACK RED CELL

PACLITAXEL

PANCURONIUMPANTOPRAZOLE

PANTOPRAZOLE + AMOXICILLIN +CLARITHROMYCIN

PARACETAMOL

- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - - 1 1- - - 1 1- - - 1 1- - 1 - 1- 2 - - 22 4 1 - 7- 1 - - 1- 1 1 - 22 24 6 - 32- - - 1 1- 1 1 - 2- - 1 - 1

- 3 - - 31 - - - 1- 1 - - 1- - 1 - 1

JAUNDICE CHOLESTATICOEDEMA PERIORBITALRESPIRATORY DISORDERURTICARIAANAPHYLACTIC SHOCKRASH ERYTHEMATOUSANAPHYLACTIC REACTIONCHEST PAINDYSPNOEAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARPRURITUSRASHRASH ERYTHEMATOUSURTICARIADYSPNOEAFLUSHINGPALPITATIONPRURITUSRASHSWEATING INCREASEDRASHPRURITUS GENITALRASHRASH ERYTHEMATOUSANAPHYLAXISANGIOEDEMAPRURITUSABDOMINAL PAINANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAASTHMABRONCHOSPASMCARPAL TUNNEL

SYNDROMECHEST PAINCOAGULATION DISORDERCONJUNCTIVITISDERMATITIS

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Spontaneous Report of Adverse Drug Reaction 2004 161

PARACETAMOL - - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 13 11 4 1 19- 1 1 - 21 1 - - 2- 2 - - 24 13 4 - 21- 2 - - 2- 7 2 - 9- 1 - - 1- 2 - - 2- 2 - - 2

- 1 - - 1

1 1 - - 22 1 - - 4- 1 - - 11 - - - 11 - - - 1- 1 - - 11 2 2 1 6- - 1 - 12 5 2 - 91 9 - - 102 16 6 - 241 4 - - 5- 3 - - 31 1 1 - 34 34 12 3 536 60 21 3 91- - 1 - 14 23 12 - 391 - - - 14 20 7 2 33- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 2 - 5

- 3 - - 3- 1 - - 1

DERMATITISDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSKINESIA TARDIVEDYSPNOEAECZEMAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFIXED ERUPTIONFLUSHINGHEADACHEHEPATIC ENZYMES

INCREASEDHEPATIC FUNCTION

ABNORMALHEPATITIS TOXICHEPATOTOXIC EFFECTHYPOTENSIONLIVER CELL DAMAGEMACULAR RASHMUCOSAL ULCERATIONNAUSEANEUROPATHYOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPAPULAR RASHPARAESTHESIAPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PETECHIALRASH PURPURICRESPIRATORY DEPRESSIONRIGORSSCLERITISSTEVENS JOHNSON

SYNDROMESTOMATITISSUFFOCATION FEELING

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PARACETAMOL

PARACETAMOL + CHLORPHENIRAMINE

PARACETAMOL + CHLORZOXAZONE

PARACETAMOL + CODEINE

PARACETAMOL + ORPHENADRINE CITRATE

- 1 - - 1- 2 - - 2

6 41 19 3 69- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 6 2 1 10- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1- - 1 - 1- - 3 - 3- 1 - - 1- 1 2 - 3- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 2 - 21 - 1 - 2- 1 - - 1- - 1 - 1- - 2 - 21 - - - 1- 2 1 - 3- - 1 - 1-- 1 - - 1- 1 2 - 3- 2 - - 2-- 1 - - 1- 2 - - 2- 1 - - 1- 2 - - 2-- 1 - - 1

SYNCOPETOXIC EPIDERMAL

NECROLYSISURTICARIAVAGINAL DISCOMFORTVERTIGOVESICULAR ERUPTIONVISION ABNORMALVISION BLURREDVOMITINGWHEALSANAPHYLACTIC SHOCKBULLOUS ERUPTIONERYTHEMA MULTIFORMEFIXED ERUPTIONPRURITUSANAESTHESIA LIPANGIOEDEMACHEST PAINDYSPNOEAFACE OEDEMAFATIGUEHEADACHEPRURITUSOEDEMA PERIORBITALRASHRASH ERYTHEMATOUSTHROAT DRYURTICARIAANAESTHESIA LOCALDIARRHOEADIZZINESSFACE OEDEMAFIXED ERUPTIONHEADACHENAUSEAOEDEMA MOUTHOEDEMA PERIORBITALPARAESTHESIAPARAESTHESIA CIRCUMORALPRURITUSRASHRASH ERYTHEMATOUSURTICARIAANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTION

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Spontaneous Report of Adverse Drug Reaction 2004 163

PARACETAMOL + ORPHENADRINE CITRATE - - 1 - 1-- 1 1 - 2- 7 5 - 12- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2-- 1 - - 1- - 1 - 1-- 1 - - 1- 4 5 - 9- - 1 - 11 4 3 - 8- 1 1 - 2- - 3 - 3- - 1 - 1- 1 - - 11 7 13 - 21-- 1 - - 1-- 2 1 - 3-- 1 1 - 2- 2 3 - 5-- 1 1 - 2- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1-- 1 - - 1-- 1 - - 11 4 4 - 9- 1 - - 1- 5 4 - 9- - 1 - 1- 1 1 - 2-- 1 - - 1- 3 - - 3-- 1 - - 1- 8 7 - 151 5 6 - 12- - 1 - 1-- 1 - - 1- 3 - - 3

ANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMAAPNOEAARTHRALGIAARTHRITISBRONCHOSPASMCHEST PAINCHILLSDERMATITIS EXFOLIATIVEDIZZINESSDAY LIPSDYSPNOEAECZEMAERYTHEMAERYTHEMA MULTIFORMEFACE MALFORMATIONFACE OEDEMAFAINTNESSFATIGUEFEVERFIXED ERUPTIONFLUSHINGGUM HYPERPLASIAHEADACHEHOT DRY SKINHOT FLUSHESMOUTH DRYMOUTH ULCERATIONMYALGIANAUSEANUMBNESSOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALPALPITATIONPAPULAR RASHPETECHIAEPHOTOSENSITIVITY

ALLERGIC REACTION

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PARACETAMOL + ORPHENADRINE CITRATE

PARACETAMOL + CHLORPHENIRAMINE +PSEUDOEPHREDRINE

PARECOXIB

1 14 16 2 331 19 16 - 36- 1 - - 11 4 7 1 13- 7 4 - 11- 1 - - 1-- - 1 - 1- 1 1 - 2

- 1 1 - 2- 3 - - 3-- 1 - - 1

-- 1 - - 12 9 8 1 20- 1 1 - 2- 2 1 - 3- 1 2 - 3- 1 - - 1

- - 1 - 1-- 1 - - 1-- 1 - - 1-- 1 - - 11 1 - - 21 1 - - 2- 1 - - 1- - 1 - 1- 1 - - 1-- 1 - - 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2

- 1 - - 1

- - 2 - 2- 1 - - 1

PRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARSTEVENS JOHNSON

SYNDROMESYNCOPETACHYCARDIATEMPERATURE CHANGED

SENSATIONTONGUE PARALYSISURTICARIAVESICULAR RASHVISION BLURREDVOMITINGWEAKNESS VOLUNTARY

MUSCLEANGIOEDEMADYSPNOEAECZEMAFACE OEDEMAHEADACHENAUSEAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGABDOMINAL DISTENSIONAIRWAYS OBSTRUCTIONASTHMABLEEDING TIME INCREASEDBRONCHOSPASMCHEST PAINCONGESTIVE HEART

FAILUREDECREASED FLUID

OUTPUTDIZZINESSDYSPNOEA

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Spontaneous Report of Adverse Drug Reaction 2004 165

PARECOXIB

PAROXETINE

PECTIN + KAOLIN + FURAZOLIDONEPEGINTERFERON ALPHA-2B

PENFLURIDOL

PENICILLAMINE

PENICILLIN + STREPTOMYCINPENICILLIN G (BENZYLPENICILLIN)

- 1 - - 1- 2 3 - 5- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - - 1 1- - - 1 1- - 2 - 2- 5 -- - 5- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 18 - 18- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1

- 1 - - 1- 1 - - 1- 1 - - 11 5 - - 6

ERYTHEMA MULTIFORMEFACE OEDEMAFAINTNESSGASTRITISHAEMORRHAGIC DISORDERHEART FAILUREHYPERTENSIONHYPOTENSIONNAUSEANECROSIS ISCHAEMICOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALPAPULAR RASHPNEUMONIAPRURITUSRASHRASH ERYTHEMATOUSRENAL FAILURE ACUTERESPIRATORY FAILURESEPSISSUBDURAL HAEMATOMAURINARY TRACT INFECTIONURTICARIAVOMITINGDIZZINESSNAUSEASOMNOLENCEVERTIGOVOMITINGRASH ERYTHEMATOUSFATIGUEINJECTION SITE PAINLEUCOPENIAMYALGIAPRURITUSRASH MACULO-PAPULARPRURITUSRASHSTEVENS JOHNSON

SYNDROMEANAPHYLACTIC SHOCKABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCK

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PENICILLIN G (BENZYLPENICILLIN)

PENICILLIN G BENZATHINE (BENZATHINEBENZYLPENICILLIN)

PENICILLIN G POTASSIUM (BENZYLPENICILLINPOTASSIUM)

1 2 - - 3- 1 - - 1- 1 1 - 2- 1 - - 11 4 1 - 6- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 13 2 - 151 19 7 - 27- 5 4 - 91 6 2 - 9- - 2 - 2- 1 - - 1- 1 - - 1

2 4 6 - 12- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 2 - - 2- 9 - - 91 12 2 - 15- 4 1 - 5- 4 3 - 7- 1 - - 1

- 2 2 - 4- 1 - - 11 14 4 - 19- 1 - - 11 1 - - 2- 2 - - 2- - 1 - 1- 1 - - 1

ANGIOEDEMAAPNOEACHEST PAINDIZZINESSDYSPNOEAECZEMAERYTHEMA MULTIFORMEFACE OEDEMAFLATULENCEMACULAR RASHNAUSEANECK TIGHTNESSOEDEMAOEDEMA PERIPHERALPAPULAR RASHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY DISTRESSSHOCKSTEVENS JOHNSON

SYNDROMEURTICARIAVERTIGOVOMITINGBRONCHOSPASMPALPITATIONRASHRASH MACULO-PAPULARURTICARIAANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMABRONCHOSPASMCARPAL TUNNEL

SYNDROMECHEILITISCHILLSDYSPNOEAERYTHEMAFACE OEDEMAFIXED ERUPTIONHYPERPIGMENTATION SKINMACULAR RASH

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Spontaneous Report of Adverse Drug Reaction 2004 167

PENICILLIN G POTASSIUM (BENZYLPENICILLINPOTASSIUM)

PENICILLIN G SODIUM (BENZYLPENICILLIN SODIUM)

- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 3 1 - 4- 1 1 - 2- 1 - - 11 11 4 - 162 17 2 - 21- 2 4 - 6- 3 1 - 4- 1 1 - 2- 1 - - 1- 1 - - 1- 7 3 - 10- 1 - - 1- 1 - - 1- - - 1 11 2 - 1 42 9 1 - 12- 2 - - 21 4 1 - 61 1 1 - 3- 1 - - 1- - 2 - 2- 1 - - 1- 1 - - 1- 7 3 1 11- 1 - - 1- 1 - - 1- 1 2 - 3- 5 1 - 6- 1 1 - 2- 4 1 1 6- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - 1 3- - 1 - 1- 1 1 - 21 1 - - 2- 2 - - 2

MIGRAINEMOUTH ULCERATIONMUSCLE WEAKNESSOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSYNCOPETINNITUSTONGUE PARALYSISURTICARIAVERTIGOVOMITINGAGITATIONANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONCHEST PAINDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAERUPTIONERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGGRANULOCYTOPENIAHEPATITISHYPERSENSITIVITYHYPOTENSIONMACULAR RASHNAEVI MELANOCYTICNAUSEANUMBNESSOEDEMA

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PENICILLIN G SODIUM (BENZYLPENICILLIN SODIUM)

PENICILLIN G SODIUM + PROCAINE PENICILLIN G +BENETHAMINE PENICILLIN G

PENICILLIN V (PHENOXYMETHYLPENICILLIN)

- 1 - - 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 19 16 - 35- - 1 - 12 41 28 - 71- 21 13 - 341 30 16 2 49- - 1 - 1- 1 1 - 2

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

3 25 14 1 43- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 14 1 - 156 16 2 - 241 2 - - 3- 6 2 - 8- 14 4 - 18- - 1 - 13 6 - - 9- - 1 - 11 - - - 1- 8 - - 8- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 2 1 - 3- 3 4 - 76 46 11 1 64- - 1 - 1- 3 1 - 4- 2 1 - 3

OEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPAINPARAESTHESIA MOUTHPRURITUSPURPURA ALLERGICRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY DISORDERSTEVENS JOHNSON

SYNDROMESTOMATITISSYNCOPETACHYCARDIATOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGPRURITUSRASH ERYTHEMATOUSABDOMINAL PAINALLERGYANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMAASTHMABRONCHOSPASMBULLOUS ERUPTIONCHEILITISCHEST PAINCONJUNCTIVITISCONVULSIONSCYST NOSDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAECZEMAERYTHEMAERYTHEMA MULTIFORME

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Spontaneous Report of Adverse Drug Reaction 2004 169

PENICILLIN V (PHENOXYMETHYLPENICILLIN)

PENICILLINS

1 17 3 - 20- 1 - - 1- 2 - - 2- 2 - - 3- 4 3 - 7- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 11 - - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 4 1 - 5- - 1 - 1- 1 - - 1- 10 5 - 15- 11 3 - 14- 1 - - 11 6 5 - 123 58 18 1 809 85 23 2 1191 30 7 - 383 34 11 - 48- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 12 4 - - 6

- - 1 - 11 - - - 1- - 1 - 1- 1 - - 11 - - - 1- - 1 - 1- 1 - - 1- - 1 - 11 51 18 1 71- - 1 - 1- - 1 - 1- 5 3 - 8- 1 - - 1- 1 - - 1- 1 - - 12 3 - - 5

FACE OEDEMAFAINTNESSFATIGUEFEVERFIXED ERUPTIONFLATULENCEGINGIVITISGUM HYPERPLASIAHEADACHEJAW STIFFNESSMACULAR RASHMUSCLE WEAKNESSNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA GENITALOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICRESPIRATORY DEPRESSIONRIGORSSHOCKSTEVENS JOHNSON

SYNDROMESTOMATITIS NECROTISINGSTOMATITIS ULCERATIVESWEATING INCREASEDSYNCOPETACHYCARDIATONGUE PARALYSISTONGUE ULCERATIONUNCONSCIOUSNESSURTICARIAVESICULAR RASHVISION BLURREDVOMITINGWEAKNESS GENERALIZEDWHEALSWHEEZING EXPIRATORYANAPHYLACTIC REACTION

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PENICILLINS

PENTAMIDINE

PENTOXIFYLLINE

- 1 - - 1- 2 - - 2- 2 - - 21 1 1 - 32 - - - 2- 1 - - 11 2 - - 3- 1 - - 1- 5 2 1 8- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 1 - 3- 2 - - 2- 3 1 - 4- 2 1 - 3- 2 - - 2- 1 - - 1- 3 - - 3- 1 - - 1- - 1 - 1- 5 5 - 101 11 6 - 18- 5 2 - 7- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1

1 3 6 - 10- 4 2 - 6- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 1 - 2

ANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXISANGIOEDEMABRONCHOSPASMBULLOUS ERUPTIONCHEST PAINDIZZINESSDYSPNOEAECZEMAERUPTIONERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFIXED ERUPTIONNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPAPULAR RASHPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRIGORSSHOCKSPASM GENERALIZEDTACHYCARDIATOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGWHEALSBRONCHOSPASMHYPOTENSIONNUMBNESS LOCALIZEDRASH ERYTHEMATOUSSHOCKVISION BLURREDABDOMINAL PAINDIZZINESSPRURITUS

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Spontaneous Report of Adverse Drug Reaction 2004 171

PENTOXIFYLLINE

PEPPERMINT OIL

PERINDOPRILPERPHENAZINE

PETHIDINE

- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 11 2 - - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- 8 1 - 9- 5 4 - 9- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 2 - 3- 1 1 - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 2 - 4- 5 2 - 7- 1 1 - 2- 1 - - 1- 2 - - 2- 1 - - 1

- 1 - - 1

- 4 1 - 5

- 3 2 - 5- 1 - - 1

RASHRASH ERYTHEMATOUSVOMITINGHEADACHEMIGRAINECOUGHINGAKINESIAANGIOEDEMABRADYCARDIACOGWHEEL RIGIDITYCONSTIPATIONDIZZINESSDYSPHAGIADYSTONIAEXTRAPYRAMIDAL DISORDERFATIGUEHYPOGLYCAEMIAHYPOTENSIONMOUTH DRYPALPITATIONPARKINSON'S SYNDROMERASHSOMNOLENCESPASM TONGUESPEECH DISORDERTONGUE PARALYSISTORTICOLLISTREMORURTICARIAANGIOEDEMAARRHYTHMIACONVULSIONSDIZZINESSDYSPNOEAFACE OEDEMAHYPERVENTILATIONHYPOTENSIONINJECTION SITE

DERMATITISINJECTION SITE

INFLAMMATIONINJECTION SITE

REACTIONNAUSEANUMBNESS

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⌦172

PETHIDINE

PHENACETIN

PHENAZOPYRIDINE + SULFAMETHIZOLE +TETRACYCLINE

PHENOBARBITAL

- 2 - - 2- - 1 - 1- 5 1 - 6- 1 1 - 2- 5 2 - 7- - 1 - 1- 14 9 - 23- 2 1 - 3- - 1 - 1- 1 1 - 2- - 1 - 11 8 5 - 14- 2 2 - 4- - 1 - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 5 - - 5- 1 - - 1- 4 2 - 6- 1 - - 1- 2 - - 2- 5 - - 5- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 11 10 3 - 141 24 7 - 32- 13 9 - 22- 21 8 - 29- - 1 - 1- - 1 - 1- - 1 - 1

OEDEMA PERIORBITALPAINPALPITATIONPHLEBITISPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSWEATING INCREASEDSYNCOPEURTICARIAVOMITINGSTEVENS JOHNSON

SYNDROMEANAPHYLACTIC SHOCKFACE OEDEMAOEDEMARASHTONGUE PARALYSISANGIOEDEMAATAXIACONFUSIONDERMATITIS EXFOLIATIVEDIZZINESSERYTHEMA MULTIFORMEEXANTHEMAFACE OEDEMAFEVERFIXED ERUPTIONFLUSHINGHEADACHEHEPATITISHYPOTENSIONMOUTH DRYMYALGIANAUSEAOEDEMA MOUTHPETECHIAEPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH SCALYRHINITISSEDATION

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Spontaneous Report of Adverse Drug Reaction 2004 173

PHENOBARBITAL

PHENOBARBITAL + ERGOTAMINE TARTRATE +TOTAL ALKALOIDS OF BELLADONNA LEAF

PHENOLPHTHALEIN

PHENOLPHTHALEIN + OXBILE (BILE SALTS)PHENYLBUTAZONE

PHENYLBUTAZONE + LIGNOCAINEPHENYLBUTAZONE + O-CARBAMOYL

PHENOXYACETIC ACID + DEXAMETHASONE +LIDOCAINE

PHENYTOIN

- 16 2 - 18

- - 1 - 1- 1 - - 1- 1 1 - 2

- 1 - - 1- 6 3 - 9- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1

- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 4 - 4- 3 2 - 5- - 1 - 1- 1 1 - 2

- - 1 - 1- 1 1 - 2

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 1 - 3- 1 - - 1

STEVENS JOHNSONSYNDROME

STOMATITISTINNITUSTOXIC EPIDERMAL

NECROLYSISUNCONSCIOUSNESSURTICARIAVOMITINGWEAKNESS GENERALIZEDWHEALSDERMATITIS CONTACTFATIGUEPALPITATIONPHOTOSENSITIVITY ALLERGIC

REACTIONRASH ERYTHEMATOUSANGIOEDEMAURTICARIARASH ERYTHEMATOUSANAESTHESIA TONGUEBULLOUS ERUPTIONDYSPNOEAFACE OEDEMAFIXED ERUPTIONGI HAEMORRHAGEHEPATITISHOT FLUSHESOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMESTOMATITISTOXIC EPIDERMAL

NECROLYSISURTICARIAFIXED ERUPTIONASTHMABRONCHOSPASMPRURITUSAGRANULOCYTOSISANGIOEDEMAASTHENIA

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PHENYTOIN - 1 2 - 3- 1 - - 1

- 1 - - 1- 1 2 - 3- 1 - - 1- 1 2 - 31 - - - 1- 2 - - 2- 1 1 - 2- 12 3 - 15- - 1 - 1

- 1 - - 1- 4 - - 4- - 1 - 1- 1 - - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 5 2 - 7- - 1 - 1- 2 4 - 61 1 1 - 3- 11 5 - 16- 1 - - 1- 1 2 - 3- 1 - - 1- 2 - - 2- 1 2 - 3

- 1 1 - 2- - 1 - 1- 1 - - 1- 4 3 - 7- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - 1 2- 1 - - 11 1 - - 2- 3 - 1 4- 3 2 - 5

ATAXIABLOOD PRESSURE

DROP ARTERIALBURNING SKINCHEILITISCHOLESTASIS INTRAHEPATICCONFUSIONCONJUNCTIVITISCONVULSIONSDERMATITISDERMATITIS EXFOLIATIVEDERMATITIS EXFOLIATIVE

AGGRAVATEDDIZZINESSDRUG ERUPTIONDYSPNOEAECZEMAEOSINOPHILIAERUPTIONERYTHEMAERYTHEMA MULTIFORMEEXANTHEMAFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONGINGIVITISGUM HYPERPLASIAHEADACHEHEPATIC ENZYMES

INCREASEDHEPATITISHOT DRY SKINHOT FLUSHESHYPERSENSITIVITYHYPOTENSIONJAUNDICELEUCOPENIALYMPHADENOPATHYMACULAR RASHMORBILLIFORM RASHMOUTH DRYMOUTH ULCERATIONMYALGIANAUSEAOEDEMAOEDEMA MOUTH

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Spontaneous Report of Adverse Drug Reaction 2004 175

PHENYTOIN

PHTHALYLSULFATHIAZOLE + METRONIDAZOLE +FURAZOLIDONE

PILOCARPINE

PIMECROLIMUSPIOGLITAZONE

PIPERACILLIN

- 1 1 - 2- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 18 12 - 301 36 15 2 542 23 14 - 393 51 22 5 78- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 11 24 8 - 33

- - 1 - 1- - 1 - 11 - - - 1

- - 1 - 1

- 2 - - 2- 1 3 - 4

- 1 - - 1- 10 11 - 21- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 5 - 5- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

OEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPANCYTOPENIAPARAESTHESIAPETECHIAEPHOTOSENSITIVITY ALLERGIC

REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PUSTULARSEDATIONSEIZURE ANOXICSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVESYSTEMIC ERYTHEMATOSUS

RASHTHERAPEUTIC RESPONSE

DECREASEDTHROMBOCYTOPENIATOXIC EPIDERMAL

NECROLYSISUNCONSCIOUSNESSURTICARIAVASCULITISVERTIGOVISUAL FIELD DEFECTWEAKNESS GENERALIZEDANGIOEDEMA

ANAESTHESIA LOCALEYE ABNORMALITYPAINERYTHEMAOEDEMAWEIGHT INCREASECHEST PAINERYTHEMA MULTIFORMEPRURITUSRASH ERYTHEMATOUSURTICARIA

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PIPERACILLIN + TAZOBACTAM

PIRACETAMPIRIBEDILPIROXICAM

- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 1 1 - 2- 3 2 - 5- 1 3 - 4- 1 - - 1- 1 - - 1- 1 - - 1- 1 2 - 3- - 2 - 2- 8 9 - 17- - 1 - 1- 1 - - 1- 2 1 - 3- 5 - - 5- - 1 - 1- 1 1 - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 4 1 - 5- 2 - - 2- 1 - - 11 5 3 - 9- 3 1 - 4- 1 - - 1- 8 1 - 91 17 6 - 24- 1 - - 1- 1 - - 12 22 5 - 29- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

ANGIOEDEMABULLOUS ERUPTIONERYTHEMAFEVERHYPERAEMIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGABDOMINAL PAINANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAARTHRALGIABREAST PAIN FEMALEBRONCHOSPASMBULLOUS ERUPTIONBURNCHEILITISCHEST PAINDERMATITISDERMATITIS CONTACTDERMATITIS EXFOLIATIVEDIARRHOEA BLOODYDIZZINESSDRUG ERUPTIONDYSPHONIADYSPNOEAECZEMAERUPTIONERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONGASTRITISGI HAEMORRHAGEGLOSSITISHAEMORRHAGE GASTRICHEADACHEHERPES SIMPLEXHYPERTONIAINFLAMMATORY OEDEMA

REACTION

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Spontaneous Report of Adverse Drug Reaction 2004 177

PIROXICAM - - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 1 - 2- 1 - - 1- 6 6 - 12- 3 1 - 4- 1 - - 1- 1 1 - 2- 9 5 1 15- 1 - - 11 10 3 - 14- 1 2 - 3- - 1 - 1- 3 2 - 5- 2 - - 2- - - 1 1- 1 - - 1- 1 - - 1

1 1 - - 2

- 17 21 1 39- - 1 - 1- - - 1 1- 23 17 - 41- 1 - - 1- 7 10 - 17- 3 - - 3- 11 3 - 14- 1 - - 1- - 3 - 3- - 1 - 1

- 9 7 - 16

- 2 1 1 4- - 1 - 1- 1 - - 11 1 - - 2

1 9 7 - 17- 1 - - 1- 1 2 - 3- 1 - - 1

JAUNDICEMACULAR RASHMELAENAMOUTH DRYMUCOSAL ULCERATIONNAUSEANUMBNESS ORALOEDEMAOEDEMA GENERALISEDOEDEMA GENITALOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALPAINPALPITATIONPAPULAR RASHPARAESTHESIAPETECHIAEPHOTOSENSITIVITY

REACTIONPHOTOSENSITIVITY TOXIC

REACTIONPRURITUSPRURITUS GENITALPURPURARASHRASH ECCHYMOTICRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARREFLEX PLANTAR

EXTENSORSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVETHROMBOCYTOPENIATOXIC EPIDERMAL

NECROLYSISURTICARIAVESICULAR ERUPTIONVESICULAR RASHVISION ABNORMAL

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PIROXICAM

PITOFENONE + FENPIVERINIUM BROMIDE +METAMIZOLE SODIUM (DIPYRONE)

PLASMINPLASTER

POLIOMYELITIS VACCINES

POLYGELINE

POTASSIUM CHLORIDE

POTASSIUM CITRATE

POVIDONE-IODINE

POVIDONE-IODINE FOR TOPICALPRAMIPEXOLE

PRAZEPAMPRAZIQUANTEL

- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- - - 1 1- - 1 - 11 - - - 11 1 - - 21 1 - - 2- 1 2 - 3- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 1 - 3- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 2 - - 21 - - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

VISION BLURREDVOMITINGANGIOEDEMADYSPNOEARASH ERYTHEMATOUSURTICARIABULLOUS ERUPTIONPRURITUSRASH ERYTHEMATOUSFEVEROEDEMA LEGSRASHFLUSHINGOEDEMA PERIORBITALPRURITUSRASHBLISTERSDYSARTHRIAHEADACHEHYPERKALAEMIAOEDEMA MOUTHPALPITATIONPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARTACHYCARDIATONGUE OEDEMAURTICARIAANOREXIAFACE OEDEMAPRURITUSRASH ERYTHEMATOUSSKIN ULCERATIONURTICARIAAPPLICATION SITE REACTIONECZEMAPAPULAR RASHRASHRASH MACULO-PAPULARURTICARIAFLUSHINGSPEECH DISORDERTREMORRASHDYSPNOEAPRURITUSRASH

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Spontaneous Report of Adverse Drug Reaction 2004 179

PRAZIQUANTEL

PRAZOSIN

PREDNICARBATEPREDNISOLONE

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 2 1 - 3- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 4 - - 4- 1 - - 1- 1 1 - 2- 1 1 - 2- 2 - - 2- 1 - - 1- - 1 - 11 - 1 - 2- - 2 - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 4 - - 4.- 1 - - 1- 2 1 - 3- 1 - - 1- 3 - - 3- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1

RASH ERYTHEMATOUSURTICARIAANGIOEDEMADIARRHOEADIZZINESSDYSPNOEAFACE OEDEMAFATIGUEFIXED ERUPTIONGUM HYPERPLASIAHEADACHEHYPOTENSIONHYPOTENSION POSTURALMOUTH DRYNAUSEAOEDEMAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH MACULO-PAPULARSYNCOPEVOMITINGRASHABDOMINAL PAINACNEACNEIFORM DERMATITISANAESTHESIA LOCALANGIOEDEMACUSHING'S SYNDROMEDIABETES MELLITUSDIZZINESSFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGGI HAEMORRHAGEHYPERGLYCAEMIAHYPOKALAEMIANAUSEANUMBNESSOEDEMAOEDEMA GENERALISEDOEDEMA LEGSPALPITATIONPEPTIC ULCER

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PREDNISOLONE

PRIMAQUINE

PROCAINE PENICILLIN G

PROCATEROL

PROCHLORPERAZINE

PROCTASE + PANCREATIN

PROMETHAZINE

PROPOFOL

PROPRANOLOL

- 1 2 - 3- 5 2 - 7- 1 - - 1- 2 - - 2- 1 2 - 3- 2 - - 2

- 2 - - 2- - 1 - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1

PRURITUSRASHRASH ACNEIFORMRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMEURTICARIAVISION BLURREDVOMITINGWEAKNESS GENERALIZEDCHEST PAINDIZZINESSECZEMANAUSEAPRURITUSRASH MACULO-PAPULARVOMITINGANAPHYLACTIC SHOCKDYSPNOEARASH MACULO-PAPULARFACE OEDEMAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSPALPITATIONURTICARIAANGIOEDEMAPRURITUSRASH MACULO-PAPULARURTICARIAANAESTHESIA LOCALASTHENIADYSTONIAPARKINSONISM AGGRAVATEDRASHSOMNOLENCETONGUE PARALYSISTREMORHYPOTENSIONRASHRIGORSTACHYCARDIAANAPHYLACTIC SHOCKALOPECIA

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Spontaneous Report of Adverse Drug Reaction 2004 181

PROPRANOLOL

PROPYLTHIOURACIL

- 2 1 - 3- - 1 - 1- 1 - - 1- 1 2 - 3- 2 - - 2- 1 - - 1- - - 1 1- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - - 1 1- 1 - - 1- 2 - - 2- 4 1 1 6- 1 - - 1- 4 1 - 5- 1 1 - 2- 2 3 - 5- 1 - - 11 - - - 1- 1 - - 1- - - 1 1- - 1 - 1- 5 - 1 6- 3 1 - 4- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 2 - 2- 1 - - 1- 1 - - 1

- - 1 - 1- 1 - - 1- - 1 - 11 - 1 - 2

ANGIOEDEMAANXIETYASTHMABRADYCARDIADIZZINESSDREAMING ABNORMALDYSPNOEADYSTONIAFACE OEDEMAFIXED ERUPTIONGINGIVAL BLEEDINGHEPATITISHYPERKALAEMIAHYPOTENSIONINSOMNIAMOUTH DRYOEDEMA MOUTHPALPITATIONPRURITUSPURPURARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRASH PURPURICSINUS BRADYCARDIASKIN ULCERATIONSYNCOPETREMORURTICARIAAGRANULOCYTOSISANGIOEDEMABULLOUS ERUPTIONDIZZINESSDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFEVERHEPATITISJAUNDICELEUCOPENIALIVER FUNCTION TESTS

ABNORMAL NOSNAUSEANEUTROPENIAOEDEMAOEDEMA PERIORBITAL

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PROPYLTHIOURACIL

PROTEIN HYDROLYSATES

PSEUDOEPHEDRINE

PYRAZINAMIDE

- 8 4 - 12

2 8 4 - 14

- 4 1 - 5

- 4 1 - 5

- 1 - - 1

- 4 2 - 6

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 2 - - 2

- 1 1 - 2

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 2 - - 2

1 - - - 1

- - 1 - 1

1 2 - - 3

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

1 - - - 1

- 4 - - 4

- 1 - - 1

1 - - - 1

- - 1 - 1

- 1 - - 1

1 - 5 - 6

- 1 2 - 3

1 1 - - 2

- 1 - - 1

PRURITUS

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

STEVENS JOHNSON

SYNDROME

URTICARIA

VASCULITIS

VOMITING

RASH MACULO-PAPULAR

ANAPHYLACTIC REACTION

DIZZINESS

FACE OEDEMA

FATIGUE

FIXED ERUPTION

FLUSHING

HEADACHE

MUSCLE WEAKNESS

NAUSEA

OEDEMA MOUTH

PALPITATION

PRURITUS

RASH

RASH ERYTHEMATOUS

SOMNOLENCE

TONGUE PARALYSIS

URTICARIA

VOMITING

WEAKNESS GENERALIZED

ARTHRALGIA

BULLOUS ERUPTION

CHEST PAIN

CHOLELITHIASIS

DERMATITIS ALLERGIC

DERMATITIS EXFOLIATIVE

DIARRHOEA

DIZZINESS

ERYTHEMA MULTIFORME

FACE OEDEMA

FATIGUE

FEVER

FIXED ERUPTION

FLUSHING

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Spontaneous Report of Adverse Drug Reaction 2004 183

PYRAZINAMIDE

PYRIDOSTIGMINE

PYRIMETHAMINE

- - 1 - 1- 1 - - 1- 2 2 - 4

2 19 20 - 41- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 10 7 - 17- 1 3 - 4- 1 - - 12 3 9 - 11- 1 - - 1- - 1 - 1- 2 1 - 3- - 2 - 2- 1 - - 1- 1 - - 1-- - 2 - 2- 1 - - 1- - 1 - 1- 14 10 - 24- 16 14 - 30- 5 3 - 8- 12 2 - 14- 1 - - 1- - 2 - 2- 4 3 - 7

- 1 - - 1- 6 2 - 8- 1 - - 12 4 5 - 11- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

HEADACHEHEPATIC DISEASEHEPATIC ENZYMES

INCREASEDHEPATITISHEPATITIS CHOLESTATICHEPATITIS INFECTIOUSHEPATOTOXIC EFFECTHOT FLUSHESHYPERBILIRUBINAEMIAJAUNDICEJAUNDICE CHOLESTATICJOINT PAINNAUSEANEUROPATHYOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALOPTIC NEURITISPAINPALPITATIONPAPULOVESICULAR RASHPERIPHERAL NEURITISPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSGOT INCREASEDSKIN NODULESTEVENS JOHNSON

SYNDROMESUFFOCATION FEELINGURTICARIAVISION ABNORMALVOMITINGDIARRHOEAHYPERSALIVATIONLACRIMATION ABNORMALTRACHEO-BRONCHIAL

SECRETION EXCESVISION BLURREDGINGIVAL BLEEDINGHAEMATOPOIESIS DECREASEDLEUCOPENIARASH MACULO-PAPULARTHROMBOCYTOPENIAULCERS APHTHOUS ORAL

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PYRIMETHAMINE, COMBINATIONS

PYRITINOL DIHYDROCHLORIDE MONOHYDRATE

PYRITINOL HYDROCHLORIDE

QUETIAPINE

QUINAPRIL

QUININE

QUININE SULFATERABEPRAZOLE

RABIES ANTISERUM

RABIES IMMUNOGLOBULIN(ERIG, RABUMAN BERNA)

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 3 - - 3- - 1 - 1- 1 - - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 11 - - - 1- - 1 - 1- - 3 - 3- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1

- 3 - - 3- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1-- - 2 - 2- 1 1 - 2- - 1 - 1- 1 2 - 3- 3 1 - 4- 1 - - 1- 2 3 - 5- 2 1 - 31 3 1 - 5

PANCYTOPENIATHROMBOCYTOPENIAFEVERHEPATIC FAILUREPRURITUSRASHRASH MACULO-PAPULARTOXIC EPIDERMAL

NECROLYSISURTICARIARASH ERYTHEMATOUSRASH MACULO-PAPULARAKATHISIADIZZINESSPARKINSONISMANGIOEDEMACHEILITISCOUGHINGDERMATITISURTICARIADIZZINESSSTEVENS JOHNSON

SYNDROMETINNITUSURTICARIAPALPITATIONPRURITUSTACHYCARDIAANGIOEDEMAMACROCYTOSISNAUSEAOEDEMA GENERALISEDOEDEMA MOUTHPRURITUSRASHRASH FOLLICULARRASH MACULO-PAPULARSLEEP APNOEAURTICARIAANAPHYLACTOID REACTIONFACE OEDEMAINJECTION SITE REACTIONOEDEMAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUS

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Spontaneous Report of Adverse Drug Reaction 2004 185

RABIES IMMUNOGLOBULIN(ERIG,RABUMAN BERNA)

RABIES VACCINE INACTIVATED

RABIES VACCINE INACTIVATED (PCEC)

RABIES VACCINE INACTIVATED (TRCS)

RABIES VACCINES

RAMIPRILRANITIDINE

- 1 1 - 2- 1 - - 1

1 1 - - 2- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 11 1 - - 2

1 1 - - 2- 1 1 - 2- - 1 - 11 3 5 - 9- 3 3 - 6- 2 2 - 4- 1 - - 1- 2 3 - 51 4 3 - 8- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 21 - - - 11 - - - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 1 - 3- - 1 - 1- 2 2 - 4- - 1 - 1- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2

RASH MACULO-PAPULARSWELLING

NON- INFLAMMATORYURTICARIAFACE OEDEMAPRURITUSRASH MACULO-PAPULARURTICARIAANAPHYLACTIC REACTIONANAPHYLACTOID REACTIONANGIOEDEMADIZZINESSFACE OEDEMAFATIGUEFEVERINJECTION SITE PAININJECTION SITE

REACTIONNAUSEAOEDEMAPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARURTICARIAHEADACHEHOT FLUSHESNAUSEARASHPRURITUSURTICARIACOUGHINGABDOMINAL PAINACNEANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAANOREXIABRONCHOSPASMDIARRHOEADIZZINESSDYSKINESIADYSPEPSIADYSPNOEA

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RANITIDINE

RANITIDINE BISMUTH CITRATE

REBAMIPIDE

REPAGLINIDE

RIBAVIRINRIFAMPICIN

- 2 - - 2- - 2 - 2- 2 3 - 5- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 1 - 3

- 2 2 - 4- - 1 - 1- 1 1 - 2- 1 2 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 10 7 - 171 12 12 1 26- 6 3 - 9- 5 2 - 7- - 1 - 1- 1 - - 1

- - 1 - 1

- 10 4 - 14- 2 1 - 3- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - - 1 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

- - 1 - 1- 1 - - 11 1 - - 2- - 1 - 1- - 1 - 11 - - - 1- - 1 - 1- 1 - - 1

DYSPNOEAERYTHEMAFACE OEDEMAFAINTNESSFIXED ERUPTIONHEPATOTOXIC EFFECTHYPERVENTILATIONINJECTION SITE

REACTIONNAUSEANUMBNESS ORALOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSPASM GENERALIZEDSTEVENS JOHNSON

SYNDROMETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGABDOMINAL PAINFACE OEDEMANAUSEARASHVOMITINGAPPETITE INCREASEDDROWSINESSHEADACHEPARAESTHESIAPARAESTHESIA MOUTHPOST-OPERATIVE

HAEMORRHAGEPRURITUSCHEILITISHYPOGLYCAEMIAFATIGUEANAEMIAANAPHYLACTIC REACTIONANGIOEDEMAANOREXIA

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Spontaneous Report of Adverse Drug Reaction 2004 187

RIFAMPICIN - 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1

- 1 - - 11 5 - - 6- 1 - - 11 - 1 - 2- 2 1 - 31 2 2 - 5- 1 - - 11 1 6 - 81 4 4 - 91 4 - - 51 - 1 - 2- 1 - - 1- 2 2 - 4

- 1 - - 11 27 21 - 491 1 - - 2- 1 1 - 2- 1 - - 1- - 1 - 1- 18 11 1 30- 4 5 - 9- 1 - - 1- 2 - - 2

3 5 9 - 17- 1 - - 1- - 1 - 1- 3 1 - 4- - 2 - 2- 1 - - 1- 1 - - 1- - 2 - 2- 1 - - 1

- - 1 - 1

ARTHRALGIAARTHRITISBILIRUBINAEMIABULLOUS ERUPTIONCHEST PAINCHOLELITHIASISCHOLESTASIS INTRAHEPATICCOUGHINGCREATININE BLOOD

INCREASEDDEAFNESSDERMATITIS EXFOLIATIVEDIARRHOEADIZZINESSDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONHEADACHEHEPATIC DISEASEHEPATIC ENZYMES

INCREASEDHEPATIC FAILUREHEPATITISHEPATITIS CHOLESTATICHEPATOTOXIC EFFECTHYPERBILIRUBINAEMIAHYPOMENORRHOEAJAUNDICEJAUNDICE CHOLESTATICLIP ULCERATIONLIVER FUNCTION TESTS

ABNORMAL NOSNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA MOUTHOEDEMA PERIORBITALORAL ULCERATIONPAINPALPITATIONPAPULOVESICULAR

RASHPERIPHERAL NEURITIS

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RIFAMPICIN

RIFAMPICIN + ISONIAZID + PYRAZINAMIDE

RIFAMPICIN + ETHAMBUTOL + ISONIAZID +PYRAZINAMIDE

RISEDRONATE SODIUM

RISPERIDONE

- 1 - - 14 16 9 - 294 11 17 - 321 11 3 - 15- - 1 - 12 16 4 - 22- 1 - - 11 1 - - 2- - 2 - 2- 6 4 - 10

2 - - - 2- 1 - - 11 - - - 1- 1 - - 1- 2 - - 2

4 8 2 - 14- 1 - - 13 6 9 - 18- 1 - - 1- 1 - - 1- 2 - - 2

- 1 1 - 2- 2 - - 2- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 2 - - 2- 1 1 - 21 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 5 - 5

PHARYNGITISPRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARSGOT INCREASEDSKIN EXFOLIATIONSKIN NODULESTEVENS JOHNSON

SYNDROMESTOMATITISSUFFOCATION FEELINGTHROMBOCYTOPENIATONGUE OEDEMATOXIC EPIDERMAL

NECROLYSISURTICARIAVISION ABNORMALVOMITINGGOUTGOUTY ARTHRITISHEPATIC ENZYMES

INCREASEDHEPATITISJAUNDICEJAUNDICE CHOLESTATICPAPULAR RASHPRURITUSRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMETHROMBOCYTOPENIATOXIC EPIDERMAL

NECROLYSISHEADACHEHEPATITISHEPATOTOXIC EFFECTPRURITUSRASHRASH MACULO-PAPULARURTICARIAFACE OEDEMAOEDEMA MOUTHPALPITATIONPRURITUSAKATHISIA

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Spontaneous Report of Adverse Drug Reaction 2004 189

RISPERIDONE

RITONAVIR

RITONAVIR + LOPINAVIR

- - 1 - 1- - 1 - 1- - 1 - 1- - 2 - 2- 2 1 - 3- 1 - - 1- 2 4 - 6- 1 2 - 3- - 2 - 2- - 1 - 12 - - - 2- - 1 - 1- - 1 - 1- 2 - - 2- 2 - - 2- 3 5 - 81 - - - 1- 4 - - 4- - 1 - 1- 1 - - 1- 1 - - 1- 4 - - 4- 2 - - 2- - 2 - 2- - 1 - 1- - 2 1 3- - - 1 1- - 3 - 3- - - 2 2- - 1 - 1- 2 2 1 5- - 2 1 3- - - 1 1- - 2 - 2- - 1 - 1- - 2 - 2- - 1 - 1

- 1 - - 1- - - 1 1

- 1 - - 1- - - 1 1- - - 1 1- - - 1 1- - - 1 1- - 2 - 2

DELUSIONDEPRESSION MENTALDIZZINESSDYSTONIAEXTRAPYRAMIDAL DISORDERHYPOTENSIONPARKINSONISMSOMNOLENCESUICIDE ATTEMPTTHROMBOSIS VENOUS DEEPTREMOR MUSCLEVISION ABNORMALWEIGHT INCREASEHYPERLIPAEMIAHYPERTRIGLYCERIDAEMIALIPODYSTROPHYNAIL DISORDERNAUSEANIGHTMARESNUMBNESS LOCALIZEDTASTE LOSSVOMITINGABDOMINAL PAINABSCESSBACK PAINCELLULITISCONJUNCTIVITISCONVULSIONSCOUGHINGDEATHDIARRHOEAFEVERHEAT RASHHERPES LABIALISHYPERLIPAEMIAHYPERTRIGLYCERIDAEMIAINTRAVENTRICULAR

HAEMORRHAGELIPODYSTROPHYLUNG FIBROSIS

INTERSTITIALNAUSEAORAL ULCERATIONPAINPAPULAR RASHPNEUMONIASEPSIS

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RITONAVIR + LOPINAVIR

RITUXIMAB

RIVASTIGMINE

ROFECOXIB

ROSIGLITAZONE

ROSUVASTATIN

- - - 1 1- - - 3 3- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 2 - 2- 2 2 - 4- 6 2 - 8- 1 - - 1- 1 - - 11 1 1 - 3- 2 1 - 3- - 1 - 11 4 - - 5- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1

- 3 - - 3- 1 - - 1- - 2 - 21 3 2 - 6- 3 6 - 9- 1 1 - 2- 3 - - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2- - 1 - 1- - 5 - 5- 1 12 - 13- - 2 - 2- - 1 - 1- - 1 - 1- 1 - - 1

ULCERS APHTHOUS ORALURTICARIAVOMITINGCHILLSCYANOSISFACE OEDEMANAUSEARASH MACULO-PAPULARVOMITINGABDOMINAL PAINANAPHYLACTIC REACTIONDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEAFACE OEDEMAFATIGUEFIXED ERUPTIONGASTRITIS HAEMORRHAGICNAUSEANEUROPATHYOEDEMAOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA OF

EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTETONGUE PARALYSISURTICARIAVERTIGOVOMITINGDIZZINESSFATIGUEHYPOGLYCAEMIAOEDEMAWEIGHT INCREASEABDOMINAL PAINBACK PAINBLEEDING FROM EARSCOUGHING

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Spontaneous Report of Adverse Drug Reaction 2004 191

ROSUVASTATIN

ROXITHROMYCIN

- - 2 - 2

- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- - 2 - 2- 1 2 - 3

- - 1 - 1

- 1 2 - 3- 2 8 - 10- - 3 - 3- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 3 2 - 5- - 1 - 1- - 1 - 1- - 1 - 1- 1 2 - 3- - 1 - 1- 3 3 - 6- 1 - - 1- 6 - - 6- 1 1 - 2- 2 1 - 3- 1 - - 1- - 1 - 1- 1 - 1 2- 4 1 1 6- 5 - - 5- 1 1 - 2- 1 3 - 4- 19 9 1 29- 17 17 3 37- 1 - - 1- 13 9 1 23

CREATINE PHOSPHOKINASEINCREASED

DIZZINESSENZYME ABNORMALITYFATIGUEFEVERHEADACHEHEPATIC ENZYMES

INCREASEDINFLUENZA-LIKE

SYMPTOMSMUSCLE WEAKNESSMYALGIANAUSEAOEDEMAPAINPALPITATIONPHARYNGITISPRURITUSRASHTHIRSTURINE ABNORMALVOMITINGABDOMINAL PAINANAPHYLACTIC REACTIONANGIOEDEMABRONCHOSPASMCONJUNCTIVITISDIARRHOEADIZZINESSDRUG ERUPTIONDYSPNOEAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONNAUSEAOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPAPULAR RASHPRURITUSRASHRASH BULLOUSRASH ERYTHEMATOUS

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ROXITHROMYCIN

SALAZOSULFAPYRIDINSALBUTAMOL

- 9 6 - 15- 1 - - 1- 1 - - 1- 3 1 - 4

- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 13 12 - 25- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1- 1 - - 1- 3 2 - 5- 1 - - 1- 1 - - 11 - 1 - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 2 - - 2- 2 - - 2- 1 - - 12 9 2 - 13- 8 2 - 10- 1 - - 12 7 1 - 10- - 1 - 1- 4 3 - 7- 2 1 - 31 - - - 1- - 1 - 11 4 - - 5- - 1 - 1

- - 1 - 1- 1 - - 1- 1 - - 1- 6 1 - 7- - 2 - 2

RASH MACULO-PAPULARRASH PURPURICSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMESTOMATITISTACHYCARDIATEMPERATURE ELEVATIONTREMBLING INSIDEURTICARIARASH ERYTHEMATOUSANAPHYLAXISANGIOEDEMACHEST PAINCHLOASMADIZZINESSDYSPNOEAERYTHEMAERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEGLOSSITISHOT FLUSHESMALAISEMUSCLE CRAMPNAUSEANUMBNESSOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSPULSE RATE INCREASEDRASHRASH BULLOUSRASH ERYTHEMATOUSRASH MACULO-PAPULARSOMNOLENCEST DEPRESSEDTACHYCARDIATHROAT SWELLING

NON-SPECIFICTHROAT TIGHTNESSTREMORTREMOR AGGREVATEDURTICARIAVOMITING

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Spontaneous Report of Adverse Drug Reaction 2004 193

SALBUTAMOL + GLYCERRYL GUAICOLATE

SALBUTAMOL FOR INHALANT

SALICYLAMIDE

SALMETEROL + FLUTICASONESAQUINAVIR

SENNA GLYCOSIDES

SERRATIOPEPTIDASE

SERTACONAZOLE

SERTRALINE

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 11 - - - 1- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - - 1 1

- 1 - - 1- - 1 - 1- - 1 - 11 - - - 1- - 1 - 1- - 1 - 1- - 2 - 2- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- 1 - - 1- 1 3 - 4- - 1 - 1- 3 4 - 7- 1 6 - 7- 1 1 - 2- 3 1 - 4- - 1 - 1- 1 - - 11 3 1 - 5- - 1 - 1- - 2 - 2- - - 1 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 2 - 21 - 1 - 2

OEDEMAPRURITUSRASH ERYTHEMATOUSDYSPNOEAMOUTH DRYNAUSEARASHTACHYCARDIAANGIOEDEMAURTICARIALARYNGITISDIARRHOEADIZZINESSDYSPNOEALUNG FIBROSIS

INTERSTITIALVOMITINGPRURITUSRASHANGIOEDEMADERMATITIS EXFOLIATIVEDIZZINESSFACE OEDEMAFEVERHEADACHEMOUTH ULCERATIONNAUSEAOEDEMA GENERALISEDOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSWELLING AURICULARTHROAT TIGHTNESSURTICARIAVESICULAR RASHVOMITINGHOT DRY SKINVAGINITISANOREXIACHEILITISDERMATITISDIZZINESSFATIGUE

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SERTRALINE

SIBUTRAMINE

SIMETHICONE

SIMETHICONE + SILICON DIOXIDE

SIMVASTATIN

- - 1 - 11 - 1 - 2- - - 1 1- - 1 - 1- - 1 - 1- - 1 - 1- - - 1 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 10 - 10- 1 - - 1- - 1 - 1- - 2 - 2- - 9 - 9- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 2 - 3- 2 - - 2- 1 1 - 2- 2 - - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 1 - 3- - 2 - 2- 1 - - 1- - 1 - 1- 1 - - 1

- 1 1 - 2- 1 - - 1- 2 - - 2

HEART DISORDERNAUSEAPALPITATIONRASHURTICARIAABDOMINAL PAINAPPENDICITISCONSTIPATIONDIZZINESSFLUSHINGINSOMNIAMOUTH DRYNAUSEAPALPITATIONRESPIRATORY DISORDERTHROAT DRYVOMITINGCHEST PAINECZEMAFLUSHINGHEADACHENAUSEANEUROPATHY PERIPHERALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGANGIOEDEMABRONCHOSPASMOEDEMA MOUTHPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARABDOMINAL PAINALOPECIAANGIOEDEMAATAXIACREATINE KINASE

INCREASEDDIZZINESSDYSPHONIADYSPNOEA

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Spontaneous Report of Adverse Drug Reaction 2004 195

SIMVASTATIN

SIROLIMUSSNAKE VENOM ANTISERUM

SODIUM BICARBONATE

- 1 1 - 2- 2 1 - 3- 1 2 - 3- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1

- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 6 1 - 7- 3 1 - 4- 2 1 - 3- 4 - - 4- - 1 - 1

- - 1 - 1- 2 1 - 3- - 1 - 1- 5 1 - 61 2 3 - 6- 1 - - 11 3 - - 4- 1 - - 1- 2 - - 2- 6 - - 6- - 1 - 1- 1 - - 1- 2 1 - 3- - 1 - 1- - 1 - 11 - - - 11 - - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 1 - 2- 2 2 - 4- - 1 - 1

ERYTHEMA MULTIFORMEFACE OEDEMAFATIGUEFIXED ERUPTIONFLATULENCEHEADACHEHEPATIC ENZYMES

INCREASEDHEPATIC FUNCTION

ABNORMALHEPATITISHOARSENESSHYPERKALAEMIAJAUNDICEMALAISEMUSCLE PAINMUSCLE WEAKNESSMYALGIAMYOPATHYMYOSITISNAUSEAOEDEMA OF

EXTREMITIESOEDEMA PERIPHERALPALPITATIONPETECHIAEPRURITUSRASHRASH ACNEIFORMRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTERHABDOMYOLYSISURTICARIAVERTIGOVOMITINGWEIGHT INCREASERASHSWEATING INCREASEDTACHYCARDIAURTICARIAHEADACHEHYPOKALAEMIAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUS

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SODIUM BICARBONATE

SODIUM CAMPHOSULPHONATE

SODIUM IOTHALAMATE + METHYLGLUCAMINEIOXITALAMATE

SODIUM IOTHALAMATE + METHYLGLUCAMINEIOXITALAMATE

SODIUM MONOFLUOROPHOSPHATESODIUM SALICYLATESODIUM VALPROATE

- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 6 1 - 7- 6 4 - 10- - 2 - 2- 1 1 - 2- - 1 - 1- 2 2 - 4- 3 - - 3- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 11 1 1 - 3- 1 - - 1- 1 1 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 - - 1- 3 1 - 4- 3 1 - 4- 2 1 - 3- 2 1 - 3- - 1 - 1

- 1 - - 1- 2 - - 2- 1 - - 12 - - - 2

RASH MACULO-PAPULARURTICARIACHILLSFEVERANOXIACHEST DISCOMFORTDIZZINESSDYSPNOEAHOT FLUSHESNAUSEAOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY DEPRESSIONURTICARIAVOMITINGURTICARIAURTICARIAAGITATIONATAXIADIZZINESSEXANTHEMAFACE OEDEMAGINGIVAL BLEEDINGHAIR LOSSHEPATITIS CHOLESTATICHYPOTENSIONMUSCLE WEAKNESSNAUSEANEUTROPENIAPALPITATIONPANCYTOPENIAPRURITUSRASHRASH ERYTHEMATOUSSEDATIONSTEVENS JOHNSON

SYNDROMESYNCOPETHROMBOCYTOPENIAVERTIGOVOMITING

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Spontaneous Report of Adverse Drug Reaction 2004 197

SODIUM VALPROATESPIRAMYCIN

SPIRONOLACTONE

STANOZOLOL

STAVUDINE

- - 2 - 2- 2 - - 2- 1 - - 1- 1 - - 1- 2 - - 2- - 2 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 3 1 - 4- - 1 - 1- 1 1 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 2 - 3- - 1 - 1- 1 - - 1- 1 2 - 31 1 2 - 4- - 2 - 2- 1 1 - 2- - 3 - 3- - 2 - 2- - 2 - 2- - 1 - 1- 3 - - 31 - - - 1- 25 20 - 45- 1 2 - 31 - 1 - 2- 2 3 - 5- 4 1 - 5- 2 1 - 3- 1 - - 1

WEAKNESS GENERALIZEDABDOMINAL PAINOEDEMA MOUTHOEDEMA PERIORBITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARURTICARIAVOMITINGGYNAECOMASTIAHOT FLUSHESHYPERKALAEMIAHYPONATRAEMIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARABDOMINAL PAINACIDOSIS LACTICANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAESTHESIA TONGUEANGIOEDEMAANOREXIAARTHRALGIACHEST DISCOMFORTDIARRHOEADIZZINESSDYSPEPSIADYSPNOEAFACE OEDEMAFATIGUEFEVERGYNAECOMASTIAHEPATITISINSOMNIALIPODYSTROPHYMYALGIANAUSEANEUROPATHYNEUROPATHY PERIPHERALPARAESTHESIAPERIPHERAL ISCHAEMIA

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STAVUDINE

STAVUDINE + LAMIVUDINE + NEVIRAPINE

- 1 - - 1

- 2 1 - 3- 5 4 - 9- 1 2 - 31 5 2 - 8- 3 1 - 4

- 1 - - 1

- - 3 - 31 - 3 - 4- - 2 - 2- 3 3 - 6- 13 1 - 14- 1 - - 1- 1 1 - 2- - 1 - 1- 8 2 - 10- 1 1 - 2- 1 - - 11 3 2 - 6- 2 1 - 3- 6 1 - 7- 1 - - 1- - 1 - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 3 - - 3- 1 - - 1- 1 1 - 21 3 2 - 6- 3 1 - 4- 5 3 1 9- - 1 - 1- 1 2 - 3- 1 1 - 2- 1 - - 1- 1 2 - 3- - 1 - 1- - 1 - 1- 4 2 - 6

PERIPHERAL SENSORYNEUROPATHY

PRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMETOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGWEIGHT DECREASEABDOMINAL PAINACIDOSIS LACTICALLERGIC REACTIONALOPECIAANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAESTHESIA TONGUEANGIOEDEMAANOREXIAARTHRALGIAARTHRITISASCITESASTHENIABACK PAINBREAST ENGORGEMENTBRONCHOSPASMBULLOUS ERUPTIONBURNING SENSATIONCHEILITISCHEST PAINCHILLSCONJUNCTIVITISDERMATITISDERMATITIS EXFOLIATIVEDIABETES MELLITUSDIARRHOEADIZZINESSDROWSINESSDRUG ERUPTIONDRY LIPSDYSPEPSIADYSPNOEA

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Spontaneous Report of Adverse Drug Reaction 2004 199

STAVUDINE + LAMIVUDINE + NEVIRAPINE - - 2 - 2

- 5 3 - 8

1 9 3 - 13

- 2 2 - 4

2 22 7 - 31

- 1 - - 1

- 2 3 - 5

- 1 1 - 1

- 5 2 - 7

- 2 - - 2

- 1 - - 1

2 39 14 - 55

- 1 - - 1

- 1 - - 1

- 4 1 - 5

- - 2 - 2

- - 1 - 1

- - 1 - 1

- 1 - - 1

- - 2 - 2

- 1 - - 1

- 7 1 - 8

-- 3 - - 3

- 1 - - 1

- 47 15 - 62

- 7 1 - 8

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 4 1 - 5

- - 1 - 1

1 12 7 - 20

- 13 4 - 17

- 12 5 - 17

- - 2 - 2

- 2 2 - 4

- 1 - - 1

ECZEMA

ERYTHEMA

ERYTHEMA MULTIFORME

FATIGUE

FEVER

FIXED ERUPTION

FLATULENCE

FLUSHING

HEADACHE

HEPATIC ENZYMES

INCREASED

HEPATIC FUNCTION

ABNORMAL

HEPATITIS

HEPATITIS CHOLESTATIC

HEPATOMEGALY

HEPATOTOXIC EFFECT

HYPERCHOLESTEROLAEMIA

HYPERKALAEMIA

HYPERLIPAEMIA

HYPERPIGMENTATION SKIN

HYPERTRIGLYCERIDAEMIA

INVOLUNTARY

MOVEMENT ORAL

JAUNDICE

LACTATE BLOOD

INCREASE

LIP ULCERATION

LIPODYSTROPHY

MACULAR RASH

MALAISE

MORBILLIFORM RASH

MUCOSAL INFLAMMATION

MUCOSAL ULCERATION

MUCOSITIS NOS

MYALGIA

MYOPATHY

NAUSEA

NEUROPATHY

NEUROPATHY PERIPHERAL

NUMBNESS

OEDEMA

OEDEMA LEGS

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STAVUDINE + LAMIVUDINE + NEVIRAPINE

STREPTOKINASE

- 9 3 - 12- 1 - - 1- 2 - - 2

- 11 6 - 17- - 1 - 1- 1 - - 1

- - 2 - 2- - 1 - 11 1 1 - 3- 4 2 - 6- 1 - - 1- 1 1 - 2- 1 - - 1

- 5 - - 51 34 7 - 42- 1 - - 1- 1 - - 11 52 26 - 793 34 10 - 47- - 1 - 1

- - 1 - 13 38 10 - 51- 1 - - 1- - 1 - 1- 1 - - 11 - - - 1- 1 - - 11 31 12 - 44

- 6 3 - 91 3 - - 4

- 6 7 - 13- - 1 - 1- - 1 - 11 12 8 - 21- 2 - - 2- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1

OEDEMA MOUTHOEDEMA NOSOEDEMA OF

EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALORAL MUCOSAL

ERUPTIONORAL ULCERATIONPAINPAIN LEGSPAPULAR RASHPARAESTHESIAPENILE HAEMORRHAGEPERIPHERAL NERVE

INJURYPERIPHERAL NEURITISPRURITUSPURPURAPYELONEPHRITISRASHRASH ERYTHEMATOUSRASH ERYTHEMATOUS

AGGRAVATEDRASH FOLLICULARRASH MACULO-PAPULARRASH SCALYSEDATIONSGPT INCREASEDSKIN EXFOLIATIONSKIN NODULESTEVENS JOHNSON

SYNDROMESTOMATITISTOXIC EPIDERMAL

NECROLYSISURTICARIAVERTIGOVISION BLURREDVOMITINGWEAKNESS GENERALIZEDWEIGHT DECREASEANAPHYLACTIC SHOCKANAPHYLAXISBLEEDING FROM EARSBLOOD PRESSURE

DROP ARTERIAL

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Spontaneous Report of Adverse Drug Reaction 2004 201

STREPTOKINASE

STREPTOMYCIN

SULBACTAM + CEFOPERAZONE SODIUM

- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 11 - 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 2 - - 2- 1 - - 1- 3 4 - 7- 2 - - 2

- 1 - - 1- - 2 - 2- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1

BRONCHOSPASMCHILLSDEPRESSIONERYTHEMAERYTHROMELALGIAGI HAEMORRHAGEGINGIVAL BLEEDINGHAEMATURIAHAEMORRHAGE

INTRACRANIALHAEMORRHAGIC DISORDERHYPOTENSIONOEDEMA PERIORBITALPRURITUSRASH MACULO-PAPULARSWEATING INCREASEDURTICARIAANAPHYLAXISANGIOEDEMAATAXIABRONCHOSPASMCINCHONISMDEAFNESSDIZZINESSDYSPNOEAEYE INFLAMEDMALAISEOPTIC NEURITISOTOTOXICITYPALPITATIONPARAESTHESIAPARAESTHESIA MOUTHPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMETINNITUSBRONCHOSPASMBULLOUS ERUPTIONDYSPNOEAFACE OEDEMAFEVERHEADACHEJAUNDICEOEDEMA

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SULBACTAM + CEFOPERAZONE SODIUM

SULFACETAMIDE

SULFADIAZINE

SULFADIAZINE AND TRIMETHOPRIM

- 1 - - 1- - 1 - 1- - 3 - 3- 3 2 - 5- - 4 1 5- 3 3 - 6- 1 - - 1

- 1 - - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 11 - 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 - - 2- 5 - - 5- 1 - - 1- 5 3 - 8- 2 - - 2

- 1 - - 1- 2 - - 2

- 1 - - 1- 2 - - 2- 1 - - 1

- 2 - - 2- 1 1 - 2- 1 - - 11 - - - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1

OEDEMA MOUTHPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITISURTICARIAANGIOEDEMACHEST PAINANAPHYLAXISANGIOEDEMAASTHENIABRONCHOSPASMBULLOUS ERUPTIONDYSPNOEAFEVERFIXED ERUPTIONGINGIVAL BLEEDINGLEUCOPENIAOEDEMA GENITALOEDEMA MOUTHPANCYTOPENIAPHOTOSENSITIVITY REACTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRESPIRATORY RATE

INCREASEDSKIN DRYSTEVENS JOHNSON

SYNDROMESTOMATITISTHROMBOCYTOPENIATOXIC EPIDERMAL

NECROLYSISURTICARIAANGIOEDEMADERMATITIS EXFOLIATIVEERYTHEMA MULTIFORMEFIXED ERUPTIONMACULAR RASHOEDEMA MOUTHPAPULAR RASH

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Spontaneous Report of Adverse Drug Reaction 2004 203

SULFADIAZINE AND TRIMETHOPRIM

SULFADIAZINE FOR TOPICAL

SULFADIMETHOXINESULFADIMIDINE

SULFADOXINE

SULFADOXINE + PYRIMETHAMINESULFAMETHIZOLE

SULFAMETHOXAZOLE

SULFAMETHOXAZOLE + TRIMETHOPRIM

- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 4 - - 4- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

1 - - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- 2 - - 2- - 1 - 1- 1 3 - 4- 1 1 - 2

- - 1 - 1- - 1 - 1- 1 - - 11 1 1 - 3- 1 - - 1- - 1 - 11 3 - - 4- - 3 - 31 1 - - 2- 7 3 - 10- 7 2 - 9- 7 - - 71 39 13 - 53- 1 - - 1- 1 - - 1

- 1 - - 1

PARAESTHESIAPRURITUSRASHRASH MACULO-PAPULARURTICARIAFACE MALFORMATIONOEDEMAPRURITUSRASH ERYTHEMATOUSTHERAPEUTIC RESPONSE

DECREASEDRASHFIXED ERUPTIONOEDEMADIZZINESSSYNCOPETHROMBOCYTOPENIAOEDEMA GENERALISEDPRURITUSRASHANAPHYLACTIC REACTIONDIZZINESSFIXED ERUPTIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITIS NECROTISINGURTICARIAVOMITINGABDOMINAL PAINANAEMIAANAESTHESIA LIPANAESTHESIA LOCALANAESTHESIA MOUTHANAESTHESIA TONGUEANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLAXISANGIOEDEMABACK PAINBONE MARROW

DEPRESSIONBRACHIAL ARTERY

THROMBOSIS

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SULFAMETHOXAZOLE + TRIMETHOPRIM - 8 1 - 91 1 - - 2

4 8 1 - 13- 1 - - 11 1 - - 2- 1 - - 13 4 1 - 8- 2 - - 21 6 - - 7- - 1 - 11 4 2 - 7- - 1 - 1- - 1 - 1- 19 13 - 32- 1 - - 1

- 3 3 - 6- 6 2 1 91 - - - 1- - 1 - 12 30 11 - 43- 1 - - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 13 1 - 142 26 10 1 39- 1 1 - 25 29 12 - 46- 1 1 - 2- 15 10 - 2515 95 27 1 138- 3 1 - 4- 1 - - 1

- 1 - - 1

- 2 - - 2- 1 - - 1- 2 1 - 3- 2 1 - 3- 1 - - 1- 6 3 - 9

BRONCHOSPASMBUCCAL MUCOSA

ULCERATIONBULLOUS ERUPTIONBURNBURNING MUCOSALBURNING SENSATIONCHEILITISCHEST CONGESTIONCHEST PAINCHILLSCONJUNCTIVITISDEATHDERMATITISDERMATITIS EXFOLIATIVEDERMATITIS

MEDICAMENTOSADIARRHOEADIZZINESSDRY LIPSDYSKINESIA TARDIVEDYSPNOEAECCHYMOSISECZEMAEMESISEPIPHORAERYTHEMAERYTHEMA MULTIFORMEEYE ABNORMALITYFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGGENITAL ERUPTION

FEMALEGENITAL ERUPTION

MALEGENITAL ULCERATIONGINGIVITISGLOSSITISGUM HYPERPLASIAHAEMATURIAHEADACHE

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Spontaneous Report of Adverse Drug Reaction 2004 205

SULFAMETHOXAZOLE + TRIMETHOPRIM - - 1 - 1

- 3 2 - 5- 1 1 - 2- - 1 - 1- 1 1 - 2- 1 2 - 3- - 1 - 1- 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 2 2 - 4- 1 - - 1- - - 1 1

- 7 3 - 10- - 1 - 1- - 1 - 1- 4 1 - 5- 1 1 - 2- - - 1 1- 1 1 - 2- 1 - - 1- 2 - - 2- 2 1 - 3- 14 3 - 17- 1 - - 1- - 1 - 12 1 - - 33 19 6 - 28- 1 - - 1- 1 - - 12 2 1 - 5- 1 - - 16 56 26 - 88- 1 - - 12 14 13 - 29- 1 - - 1- 1 - - 1- 1 - - 1

- 3 - - 31 - - - 1- 1 1 - 2

HEPATIC ENZYMESINCREASED

HEPATITISHEPATOTOXIC EFFECTHOT DRY SKINHYPERPIGMENTATION SKINHYPERSENSITIVITYHYPERTENSIONINFLAMMATORY SWELLINGJAUNDICELEG PAINLEUCOPENIALIP SORENESSLIP ULCERATIONLIPODYSTROPHYLUNG FIBROSIS

INTERSTITIALMACULAR RASHMIGRAINEMORBILLIFORM RASHMOUTH DRYMOUTH IRRITATIONMOUTH ULCERATIONMUCOSAL ULCERATIONMUSCLE ACHEMUSCLE WEAKNESSMYALGIANAUSEANEUROPATHYNUMBNESS LOCALIZEDNUMBNESS ORALOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA GENITALOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALOEDEMA PHARYNXORAL MUCOSAL

ERUPTIONORAL ULCERATIONORCHITISPAIN

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SULFAMETHOXAZOLE + TRIMETHOPRIM - 14 7 - 211 8 - - 9- 2 2 - 4- - 1 - 1

1 - - - 1- 1 - - 1- - 1 - 11 - - - 1

- - 4 - 4- 1 1 - 2

- - 3 - 3

19 159 64 1 243- 1 1 - 210 192 95 4 3011 3 - - 45 108 52 - 165- 3 1 - 412 119 43 - 174- - 1 - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 1 2- 1 - - 1- 1 - - 1

- 1 1 - 25 56 26 - 87

1 11 11 - 23- 1 1 - 2- 2 - - 2- 2 - - 2- 1 - - 1- 1 - - 1- - 1 1 22 12 1 - 15

PALPITATIONPAPULAR RASHPARAESTHESIAPARAESTHESIA

CIRCUMORALPARAESTHESIA MOUTHPENILE HAEMORRHAGEPERIPHERAL NEURITISPERIPHERAL SENSORY

NEUROPATHYPHARYNGITISPHOTOSENSITIVITY

ALLERGIC REACTIONPHOTOSENSITIVITY

REACTIONPRURITUSPURPURARASHRASH BULLOUSRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRASH PURPURICRASH PUSTULARRESPIRATORY DEPRESSIONRESPIRATORY DISTRESSRHINITISRIGORSSKIN DRYSKIN EXFOLIATIONSKIN FLUSHEDSKIN REACTION

LOCALISEDSKIN ULCERATIONSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS NECROTISINGSTOMATITIS ULCERATIVESYNCOPETACHYCARDIATHROMBOCYTOPENIATONGUE ULCERATIONTOXIC EPIDERMAL

NECROLYSIS

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Spontaneous Report of Adverse Drug Reaction 2004 207

SULFAMETHOXAZOLE + TRIMETHOPRIM

SULFAMETHOXYPARAZINE + TRIMETHOPRIM

SULFAMETHOXYPYRAZINE

SULFAMETHOXYPYRIDAZINE

SULFANILAMIDE

SULFASALAZINE

SULINDAC

2 97 47 2 148

- - 1 - 1

- - 1 - 1

- 1 1 - 2

1 - - - 1

1 3 - - 4

1 15 4 1 21

1 - - - 1

- 2 - - 2

- 1 - - 1

- 2 - - 2

- 1 - - 1

- 2 1 - 3

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- - 1 - 1

- 1 - - 1

- 1 - - 1

- 1 1 - 2

- 1 - - 1

- 1 - - 1

- 1 - - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- - 1 - 1

- 2 - - 2

- 2 - - 2

- - 1 - 1

- 1 - - 1

- - 1 - 1

1 - - - 1

URTICARIA

URTICARIA ACUTE

VASCULITIS

VERTIGO

VESICULAR ERUPTION

VESICULAR RASH

VOMITING

VOMITING AGGRAVATED

ANGIOEDEMA

FEVER

PRURITUS

RASH

RASH MACULO-PAPULAR

STEVENS JOHNSON

SYNDROME

THROAT TIGHTNESS

VOMITING

FIXED ERUPTION

RASH ERYTHEMATOUS

STEVENS JOHNSON

SYNDROME

FACE OEDEMA

PRURITUS

RASH

SYNCOPE

URTICARIA

ABDOMINAL DISTRESS

ANGIOEDEMA

FACE OEDEMA

FEVER

GASTRO-INTESTINAL

DISORDER NOS

HEADACHE

NAUSEA

OEDEMA PERIORBITAL

PRURITUS

RASH

RASH ERYTHEMATOUS

RASH MACULO-PAPULAR

VERTIGO

DERMATITIS EXFOLIATIVE

DIARRHOEA

DYSPNOEA

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SULINDAC

SULPHUR FOR TOPICAL

SULPIRIDE

SULPROSTONE

SULTAMICILLIN

SUXAMETHONIUMTACROLIMUS

TADALAFILTAMOXIFENTAMSULOSIN

TEGAFUR + URAMUSTINETEGASEROD

TEICOPLANINTELITHROMYCIN

TELMISARTAN

1 - - - 1- - 1 - 11 - 1 - 2- 2 1 - 3- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 6 - 6- - 7 - 7- - 2 - 2- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 2 - 2- - - 1 1- - - 1 1- 1 - - 1- - - 1 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1

OEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARVOMITINGFACE OEDEMAPRURITUSRASHPRURITUSRASHPRURITUSSWELLING

NON-INFLAMMATORYURTICARIADIARRHOEAFACE OEDEMAOEDEMA PERIORBITALPRURITUSRASH MACULO-PAPULARURTICARIARASHBURNING SENSATIONBURNING SKINPRURITUSRASHRASH ERYTHEMATOUSFLUSHINGOPTIC ATROPHYPALPITATIONURTICARIADIZZINESSHEADACHEMIGRAINERASH MACULO-PAPULARDIZZINESSNAUSEARASH MACULO-PAPULARVOMITINGCHEST PAINCOUGHINGDIZZINESSNAUSEARASHVERTIGO

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TELMISARTANTEMAZEPAMTENOFOVIR DISOPROXIL

TENOXICAM

TERBINAFINE

TERBUTALINE

TERBUTALINE FOR INHALANT

TETANUS ANTITOXIN

TETANUS TOXOID ANTIGEN (MULTITEST CMI)

- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 2 - 3- 1 - - 1- 2 - - 2- - 3 - 3- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1

- 2 - - 2

VOMITINGOEDEMA PERIORBITALACIDOSIS LACTICANAEMIAANGIOEDEMAHEPATIC ENZYMES

INCREASEDHEPATOTOXIC EFFECTLEUCOPENIARASHDIZZINESSFEVERFIXED ERUPTIONNAUSEAOEDEMA MOUTHPRURITUSRASH ERYTHEMATOUSURTICARIAVOMITINGANOREXIADIZZINESSPRURITUSRASHRASH ERYTHEMATOUSABDOMINAL PAINANGIOEDEMADIZZINESSFATIGUENERVOUSNESSPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTACHYCARDIAURTICARIATACHYCARDIATREMORNAUSEAOEDEMA PERIPHERALPRURITUSRASHURTICARIAVOMITINGINJECTION SITE

INFLAMMATIONOEDEMA

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TETANUS TOXOID ANTIGEN (MULTITEST CMI)

TETANUS TOXOID (ANATOXAL, ANATETALL)

TETANUS TOXOID, ABSORB (TETAVAX)

TETANUS VACCINE

TETRACAINE

TETRACYCLIC DERIVATIVES

TETRACYCLINE

- - - 1 1- - 1 - 1- - 1 - 1- 2 - - 2- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 11 - 1 - 1

- - 1 - 1- - 1 - 1- 1 - - 1- 2 1 - 3- 1 - - 1- 1 - - 1- 2 - - 2- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 11 - 1 - 11 1 - - 1- 2 - - 2- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 3 - 4- 1 - - 1- 2 1 - 3

OEDEMA GENERALISEDPRURITUSRASHRASH ERYTHEMATOUSURTICARIAANAESTHESIA LOCALANGIOEDEMAERYTHEMAINJECTION SITE

INFLAMMATIONOEDEMAOEDEMA MOUTHOEDEMA OF EXTREMITIESPRURITUSRASHRASH ERYTHEMATOUSSYNCOPEVOMITINGINFLAMMATION LOCALIZEDPRURITUSRASHRASH ERYTHEMATOUSINJECTION SITE PAINNAUSEAPALPITATIONPRURITUSRASH MACULO-PAPULARURTICARIAVOMITINGANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAFACE OEDEMAFIXED ERUPTIONOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSFIXED ERUPTIONURTICARIAANAESTHESIA LIPANAESTHESIA LOCALANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANAPHYLAXIS

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Spontaneous Report of Adverse Drug Reaction 2004 211

TETRACYCLINE - 1 5 - 14- - 1 - 1- - 1 - 1- 4 - - 4- 5 1 - 61 - - - 1- 2 - - 2- 4 2 - 6- 2 - - 2- 3 - - 3- 1 - - 1- 2 - - 1- - 1 - 11 10 2 - 13- - 1 - 1- 1 1 - 21 5 - - 6- 1 - - 1- - 1 - 11 9 5 - 15- 1 - - 1- 1 - - 110 36 9 - 55- 1 1 - 2- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 5 2 - 7- 7 1 - 81 - - - 1- 1 - - 11 - - - 11 21 8 - 30- 5 4 - 9- 1 - - 1- - 1 - 1- - 1 - 11 - 1 - 2- 1 - - 11 1 - - 2

ANGIOEDEMABLEPHARITISBLISTERSBRONCHOSPASMBULLOUS ERUPTIONCELLULITISCHEILITISCHEST PAINCONJUNCTIVITISDERMATITIS EXFOLIATIVEDIZZINESSDRUG ERUPTIONDRY LIPSDYSPNOEAERUPTIONERYTHEMAERYTHEMA MULTIFORMEERYTHROMELALGIAEYE IRRITATIONFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONFLUSHINGFOLLICULITISHAEMOPTYSISHEADACHEHYPERPIGMENTATION SKINHYPOTENSIONINFECTION LOCALISEDMACULAR RASHMOUTH DRYNAUSEAOEDEMAOEDEMA DEPENDENTOEDEMA GENERALISEDOEDEMA GENITALOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALOESOPHAGITISPAINPALPITATIONPAPULAR RASHPHOTOSENSITIVITY

ALLERGIC REACTION

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TETRACYCLINE

THEOPHYLLINE

1 32 10 - 49- 1 - - 11 28 8 - 37- 23 7 - 30- 17 7 - 24- 1 - - 1- - 1 - 1- 6 2 - 8

- 3 1 - 4- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1

- 19 8 - 27- 6 2 - 8- - 2 - 2- 1 - - 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 2 1 - 31 - - - 1

1 - 2 - 3- - 1 - 1- 1 - - 1- - 1 - 11 - - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- 1 - - 1- - 1 - 1- 4 2 - 6- 2 - - 2- - 1 - 1- 1 - - 1- - 1 - 1- 3 1 - 4- 1 - - 1- 4 2 - 72 5 5 1 13

PRURITUSPRURITUS GENITALRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTESKIN DISCOLOURATIONSTEVENS JOHNSON

SYNDROMESTOMATITISSTOMATITIS ULCERATIVESYNCOPETONGUE PARALYSISTOXIC EPIDERMAL

NECROLYSISURTICARIAVOMITINGANGIOEDEMAANOREXIABRONCHOSPASMCARDIAC ARRHYTHMIA NOSCHEST PAINCOUGHINGDIZZINESSDYSPNOEAEPIGASTRIC PAIN

NOT FOOD-RELATEDFACE OEDEMAFATIGUEFIXED ERUPTIONGLOSSITISHEADACHEHEPATITISHOT FLUSHESHYPONATRAEMIAINSOMNIAJOINT PAINMUCOSITIS NOSNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA GENITALOEDEMA PERIORBITALPALPITATIONPARAESTHESIAPRURITUSRASH

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Spontaneous Report of Adverse Drug Reaction 2004 213

THEOPHYLLINE

THEOPHYLLINE + GLYCERYL GUAIACOLATE

THIOPENTAL

THIORIDAZINE

THYROXIN SODIUM

TIAPROFENIC ACIDTIBOLONE

TICLOPIDINE HYDROCHLORIDE

TILUDRONIC ACID

TIMOLOLTINIDAZOLE

1 3 - - 4- - 1 - 1- - 1 - 11 4 - - 5- 1 - - 11 1 1 - 3- 2 2 - 4- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2- 1 1 - 2- - 1 - 1- 1 1 - 2- - 1 - 1

- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1-- - 1 - 1- - 1 - 1- 1 - - 1-- 1 - - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2- - 1 - 1- - 1 - 1

- 1 - - 1- 1 - - 1

RASH ERYTHEMATOUSRASH MACULO-PAPULARSTOMATITISTACHYCARDIATREMORURTICARIAVOMITINGANGIOEDEMARASHRASH ERYTHEMATOUSURTICARIARASHRASH MACULO-PAPULARURTICARIADIZZINESSDYSTONIAEXTRAPYRAMIDAL

DISORDERPARKINSONISMRASHVESICULAR RASHALOPECIANAUSEAPALPITATIONRASHRASH MACULO-PAPULARURTICARIADERMATITISRASH MACULO-PAPULARDIZZINESSDYSPEPSIADYSPNOEAFLATULENCEHEPATITIS CNEUROPATHYNEUROPATHY PERIPHERALNEUTROPENIARASHRASH ERYTHEMATOUSRASH MACULO-PAPULARTREMORGASTRIC ULCER

HAEMORRHAGICASTHMA AGGRAVATEDANAESTHESIA MOUTH

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TINIDAZOLE

TIONSPORA CRISPA (L.) ()TIOTROPIUM BROMIDE

TIZANIDINETOBRAMYCIN

TOLPERISONE

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- - 3 - 3- - 1 - 1- - 1 - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 8 - - 8- - 1 - 1- 1 - - 1- 2 1 - 3- 1 - - 1- - 1 - 11 - 2 - 3- 8 12 - 20- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1-- 13 6 - 19- 1 - - 1- - 1 - 11 2 1 - 4- 1 - - 1- 1 - - 1- 1 - - 1

- 1 1 - 21 3 2 - 6- 1 3 - 4- 1 - - 1- 1 2 - 3- 4 3 - 7- - 1 - 1- 7 5 - 12- - 1 - 1- 2 1 - 3- 1 - - 1

FACE OEDEMAPRURITUSRASHURTICARIAHEPATITISDIZZINESSMOUTH DRYTHROAT DRYFATIGUESTEVENS JOHNSON

SYNDROMEABDOMINAL PAINACNEIFORM DERMATITISANAESTHESIA MOUTHANAPHYLACTIC SHOCKANGIOEDEMAARTHRITISASTHMABRONCHOSPASMBURNDERMATITIS EXFOLIATIVEDIZZINESSDYSPNOEADYSTONIAEPIPHORAERYTHEMA MULTIFORMEERYTHROMELALGIAEYE PAINFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONGUM HYPERPLASIAHYPERTENSIONLIPS SWELLING

NON-SPECIFICMACULAR RASHNAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA OF EXTREMITIESOEDEMA PERIORBITALOEDEMA PERIPHERALPALPITATIONPARAESTHESIA

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Spontaneous Report of Adverse Drug Reaction 2004 215

TOLPERISONE

TOLTERODINETOPIRAMATETRAMADOL

- 1 - - 1- 19 14 3 361 19 17 - 37- 13 6 1 20- 2 1 - 3- 9 1 - 10- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 1 - 2

- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 24 10 - 34- 2 2 - 4- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 3 - - 3- 1 1 - 2- 2 - - 2- 2 - - 2- 1 - - 1- 1 2 - 3- 2 - - 2- - 1 - 1- - 1 - 1- 1 - - 12 22 16 - 392 - - - 2- 10 7 - 171 1 - - 2- 1 - - 1- 3 1 - 4- 3 2 - 5- 1 - - 1- - 1 - 1- 2 3 - 5- 1 - - 1- - 1 - 1

PARAESTHESIA CIRCUMORALPRURITUSRASHRASH ERYTHEMATOUSRASH FOLLICULARRASH MACULO-PAPULARRESPIRATORY DEPRESSIONROSACEASERUM SICKNESSSLEEP DISORDERSTEVENS JOHNSON

SYNDROMESTOMATITISSWEATING INCREASEDSYNCOPETACHYCARDIAURTICARIAVOMITINGWEAKNESS GENERALIZEDHEADACHERASH ERYTHEMATOUSABDOMINAL PAINANAESTHESIA LOCALANAESTHESIA MOUTHANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKANGIOEDEMAARRHYTHMIABRONCHOSPASMCHEST PAINCONVULSIONSCONVULSIONS AGGRAVATEDDIARRHOEADIZZINESSDROWSINESSDYSPNOEAERYTHEMAEYE PAINFACE OEDEMAFATIGUEFEVERFIXED ERUPTIONHEADACHEHOT DRY SKINILLUSION

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TRAMADOL

TRAMADOL + PARACETAMOL

TRANEXAMIC ACID

TRAVOPROST

- - 1 - 1- - 1 - 1- 3 - - 31 25 22 - 48- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 2 1 - 3- - 1 - 13 10 10 - 23- 1 - - 1- 19 11 1 31- 16 10 1 27- 8 3 - 11- 7 2 - 9- 1 2 - 3

- - 1 - 1- 1 - - 1- 2 1 - 3- 2 - - 2- 1 - - 1- - 2 - 2

- 1 - - 1- 3 7 - 10- 3 2 - 5- 1 - - 11 28 17 - 46- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 2 13 - 15- 1 - - 1- 1 1 - 2- - 1 - 1- 2 8 - 10- - 12 - 12- - 1 - 1- 1 - - 1- 2 6 - 8- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

JAUNDICEMOUTH DRYMUSCLE WEAKNESSNAUSEANEUROPATHY PERIPHERALNUMBNESSOEDEMAOEDEMA MOUTHOEDEMA PERIORBITALPAINPALPITATIONPARAESTHESIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARSTEVENS JOHNSON

SYNDROMESTOMATITISSWEATING DECREASEDSWEATING INCREASEDSYNCOPETONIC CONVULSIONTOXIC EPIDERMAL

NECROLYSISTREMORURTICARIAVERTIGOVISION ABNORMALVOMITINGWEAKNESS GENERALIZEDAGITATIONANAESTHESIA LOCALCONSTIPATIONDIZZINESSDYSPNOEAFATIGUEMOUTH DRYNAUSEASOMNOLENCEURTICARIAVISION BLURREDVOMITINGRASHURTICARIAEYE ABNORMALITYOEDEMA PERIORBITAL

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Spontaneous Report of Adverse Drug Reaction 2004 217

TRIAMCINOLONE

TRIAMCINOLONE FOR TOPICAL

TRIAZOLAMTRIFLUOPERAZINE

TRIHEXYPHENIDYL

TRIMETAZIDINETRIPROLIDINE

- 1 - - 1- 1 - - 1

- - 1 - 1- 1 - - 1

- 1 - - 1

- 1 - - 1- 2 - - 2- 1 1 - 2- 2 - - 2- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 10 1 - 10- 3 2 - 5

- 1 - - 1- 1 1 - 2- - 2 - 2- - 1 - 1- - 1 - 1- 1 1 - 2- 1 - - 1- - 1 - 1

- - 1 - 1- 1 1 - 21 - - - 1- 1 - - 11 - - - 1- - - - -1 1 1 - 3- - - - -- 1 - - 11 - - - 1- - 1 - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 - - 1- 1 - - 1

ANAESTHESIA LOCALANAPHYLACTIC

REACTIONANAPHYLACTIC SHOCKANAPHYLACTOID

REACTIONAPPLICATION SITE

REACTIONPRURITUSRASHRASH MACULO-PAPULARURTICARIAPRURITUSRASHCONFUSIONAKATHISIACONSTIPATIONDYSPHAGIADYSTONIAEXTRAPYRAMIDAL

DISORDEROEDEMAPARKINSONISMPRURITUSRASH ERYTHEMATOUSRASH MACULO-PAPULARTREMORTREMOR MUSCLEANTICHOLINERGIC

SYNDROMECONFUSIONDYSTONIAFEVERINSOMNIAMOUTH NECROSISPARALYSISRASH MACULO-PAPULARSALIVA INCREASEDSTOMATITISTONGUE PAINTREMOR LIMBURTICARIABLOOD PRESSURE

DROP ARTERIALCONVULSIONSOEDEMA MOUTHRASH

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TRIPROLIDINETRIPROLIDINE + PSEUDOEPHEDRINE

TROSPIUM

TRYPSIN

URSODEOXYCHOLIC ACID

VACCINESVALACICLOVIR

- 1 - - 1- 1 - - 1- - - 1 11 1 2 - 4- 1 - - 1

- 1 1 - 2- 1 - - 1- 1 - - 11 1 2 - 42 3 - - 5- - 1 - 1- - 2 - 2- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 12 1 1 - 41 1 1 - 31 3 3 - 7- 5 1 - 6- 6 5 - 11- 2 2 - 4- - 2 - 21 - - - 1- - 1 - 1

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 3 3 - 6- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1

WEAKNESS GENERALIZEDANAPHYLACTIC SHOCKANAPHYLACTOID REACTIONANGIOEDEMABLOOD PRESSURE

DROP ARTERIALCHEST PAINCONJUNCTIVITISCONVULSIONSDYSPNOEAFACE OEDEMAFAINTNESSFIXED ERUPTIONFLATULENCEHEADACHEMOUTH DRYNUMBNESS LOCALIZEDOEDEMA MOUTHOEDEMA PERIORBITALPALPITATIONPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRIGORSSTEVENS JOHNSON

SYNDROMESWEATING INCREASEDSYNCOPETONGUE PARALYSISURINARY RETENTIONURTICARIAWEAKNESS GENERALIZEDDIZZINESSFATIGUENAUSEARASH ERYTHEMATOUSURTICARIAJAUNDICENAUSEAOEDEMA MOUTHRASHRENAL FAILURE ACUTEVOMITINGURTICARIAASTHENIA

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Spontaneous Report of Adverse Drug Reaction 2004 219

VALACICLOVIR

VALDECOXIB

- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 2 - 2

- - 1 - 1

- 1 - - 1- - 1 - 1

- - 1 - 1

- - 1 1 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 1 - 2- - 1 - 1- 2 2 - 4- - 1 - 1

- - 1 - 1- - - 1 1- - 1 - 1- - 1 - 1- 1 3 - 4- - 1 - 1- 1 - - 1- - 1 - 1- 1 1 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 3 3 - 6- 3 5 - 8- 2 5 - 7- 1 1 - 2- - 1 - 1- 1 2 - 3

- - - 1 1- 1 - - 1- - 2 - 2

NAUSEAVOMITINGABDOMINAL DISCOMFORTABDOMINAL DISTENSIONABDOMINAL PAINASTHMA EXTRINSICBLEEDING TIME

INCREASEDBLOOD UREA

NITROGEN INCREASEDCONSTIPATIONCREATINE PHOSPHOKINASE

INCREASEDCREATININE BLOOD

INCREASEDDIARRHOEADIZZINESSDYSPEPSIADYSPNOEAECCHYMOSISERYTHEMA MULTIFORMEFACE OEDEMAGASTROINTESTINAL

TRACT BLEED NOSHEADACHEHEARING DECREASEDHYPERTENSIONINSOMNIANAUSEAOEDEMAOEDEMA GENERALISEDOEDEMA LEGSOEDEMA MOUTHOEDEMA PERIORBITALOEDEMA PERIPHERALPOLYURIAPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRENAL FAILURE ACUTESTEVENS JOHNSON

SYNDROMETINNITUSURTICARIAVOMITING

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VANCOMYCIN

VARDENAFIL

VECURONIUMVENLAFAXINE

- 1 - - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 - - 1- - 1 - 1- 1 3 - 4- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 9 3 - 121 13 8 - 22- 11 8 - 191 3 6 - 10- 6 2 - 8- - 1 - 1

- 1 - - 1- 1 1 - 2

- - 1 - 1- 1 - - 1- 4 1 - 5- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 5 - 5- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- 1 - - 1

ACNEIFORM DERMATITISANAPHYLAXISBRADYCARDIADYSPNOEAEOSINOPHILIAERYTHEMA MULTIFORMEFACE OEDEMAFEVERFLUSHINGHOT DRY SKINHYPOTENSIONINJECTION SITE PAINLEUCOPENIAMACULAR RASHMORBILLIFORM RASHOEDEMAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARRED MAN SYNDROMERENAL FUNCTION

ABNORMALSKIN EXFOLIATIONSTEVENS JOHNSON

SYNDROMETACHYCARDIATINNITUSURTICARIAVOMITINGDIZZINESSEFFICACY, LACK OFFATIGUEFLUSHINGHEADACHENASAL CONGESTIONVISION ABNORMALURTICARIAMOUTH DRYNAUSEAPARAESTHESIA MOUTHSOMNOLENCETHRUSH

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Spontaneous Report of Adverse Drug Reaction 2004 221

VENLAFAXINEVERAPAMIL

VINORELBINEVINPOCETINE

VITAMIN A + VITAMIN B1-B2-B6 +VITAMIN C + VITAMIN E

VITAMIN A AND VITAMIN D IN COMBINATION

VITAMIN A AND VITAMIN D, INCLUDECOMBINATIONS OF THE TWO

VITAMIN B1VITAMIN B1-B2-B6-B12 + VITAMIN A +

VITAMIN C + VITAMIN D +NICOTINAMIDE + HONEY

VITAMIN B1-B6-B12

VITAMIN B6 (PYRIDOXINE)

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 2 - - 2- - - 1 1- 1 1 - 2- - 1 - 1

- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1

- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 2 - 2- - 1 - 1

- 1 - - 1- - 1 - 1- 1 - - 1- - 2 - 2- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 2 - 2- - 1 - 1- 1 1 - 2- 3 1 - 4- 4 5 - 9- 2 5 1 8- 4 2 - 6- 2 - - 2- - 1 - 1

- - 1 - 1

- - 1 - 1- - 1 - 1

TONGUE DISORDERAV BLOCKHEPATIC DAMAGEOEDEMA PERIORBITALPALPITATIONPRURITUSRASH ERYTHEMATOUSSTEVENS JOHNSON

SYNDROMEANAPHYLAXISFACE OEDEMARASH MACULO-PAPULARRASH ERYTHEMATOUS

PRURITUSRASH ERYTHEMATOUSPRURITUSRASH MACULO-PAPULARPRURITUSRASH

ANAPHYLACTOID REACTIONARTHRALGIACONFUSIONDIZZINESSDYSPNOEADYSTONIAFATIGUEFIXED ERUPTIONHEADACHEHOT FLUSHESOEDEMAOEDEMA PERIORBITALPRURITUSRASHRASH ERYTHEMATOUSRASH MACULO-PAPULARREFLEX PLANTAR

EXTENSORTOXIC EPIDERMAL

NECROLYSISURTICARIAARTHRALGIA

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VITAMIN B-COMPLEX + ZINC

VITAMIN B-COMPLEX WITH MINERALSVITAMIN B-COMPLEX, PLAIN

VITAMIN K

VITAMIN KVITAMIN K (PHYTOMENADION)

VITAMINS WITH MINERALS

VOGLIBOSE (BASEN)

WARFARIN

- 1 - - 1- - 1 - 1- 1 1 - 2- 1 1 - 2- - - 1 1- - - 1 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 1 - 2- 4 1 - 5- 3 2 1 6- - 1 - 1- - - 1 1- 1 1 - 2- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 1- 1 - - 11 - - - 1- - 1 - 1- - 1 - 11 - - - 1- - 1 - 11 - - - 11 - - - 11 - - - 1- - 1 - 1

- - 1 - 1- 1 - - 1- - 1 - 11 - - - 1- - 1 - 1- 3 1 - 4- 1 - - 1- - 1 - 1

PRURITUSRASH ERYTHEMATOUSURTICARIARASHAIR HUNGERBULLOUS ERUPTIONDIZZINESSDYSPNOEAERYTHEMA MULTIFORMEOEDEMA PERIORBITALPRURITUSRASHTREMORUNCONSCIOUSNESSURTICARIAVOMITINGANAPHYLACTIC REACTIONANAPHYLACTIC SHOCKBRONCHOSPASMDYSPNOEAFLUSHINGPALPITATIONRASH MACULO-PAPULARVERTIGOPALPITATIONSYNCOPEANGIOEDEMAOEDEMA GENERALISEDRASH MACULO-PAPULARDIARRHOEADYSPNOEAFLATULENCENAUSEAOEDEMA LEGSPRURITUSRASHVOMITINGBLEEDING TIME

INCREASEDBLOOD IN STOOLBRUISECEREBRAL HAEMORRHAGECOAGULATION DISORDERDYSPEPSIAECCHYMOSISEPISTAXISGASTRITIS HAEMORRHAGIC

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WARFARIN

ZIDOVUDINE (AZT)

ZINGIBER CASSUMUNAR ROXB. ()

ZIPRASIDONE

ZOLEDRONIC ACID

- 2 - - 2- 9 2 - 11- - 1 - 1- 3 - - 3- 1 - - 1- 1 - - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 - - 1- 1 2 - 3

- 8 1 - 9- - 1 - 11 - - - 1- 1 - - 1- 8 - - 8- - 1 - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1- 1 1 - 2

- 1 - - 1- 1 - - 1- - 1 - 1- 2 1 - 3- 1 - - 1- 1 2 - 3- 1 - - 1- 1 1 - 2- - 2 - 2- - 3 - 3- 1 1 - 2- - 1 - 1- 3 2 - 5- - 1 - 1- - 1 - 1- 1 - - 1- - 1 - 1- 1 - - 1

- 1 - - 1- 1 - - 1

GI HAEMORRHAGEGINGIVAL BLEEDINGHAEMATOMAHAEMATURIAHAEMOPTYSISHYPOGLYCAEMIAMELAENANECROSIS ISCHAEMICPEPTIC ULCERPETECHIAEPROTHROMBIN TIME

PROLONGEDPURPURARASHVAGINAL HAEMORRHAGEACIDOSIS LACTICANAEMIAANAESTHESIA LIPARTHRALGIABACK PAINBRONCHOSPASMDERMATITIS EXFOLIATIVEFEVERHEADACHEHEPATIC ENZYMES

INCREASEDHEPATOTOXIC EFFECTLEUCOPENIALIPODYSTROPHYMYALGIAMYOPATHYNAUSEAPALLORPALPITATIONPRURITUSRASHRASH MACULO-PAPULARTIREDNESSVOMITINGPRURITUSRASHRASH ERYTHEMATOUSDIZZINESSEXTRAPYRAMIDAL

DISORDERDYSPNOEAPALPITATION

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ZOLMITRIPTAN

ZOLPIDEM

ZUCLOPENTHIXOL

- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- - 1 - 1- 1 - - 1- 1 - - 1- - 1 - 1- - 1 - 1- 1 - - 1- 6 2 - 8- 1 - - 1

- 1 - - 1- 2 - - 2- 1 1 - 2- - 1 - 1- - 1 - 1

NAUSEAVOMITINGAGITATIONAMNESIADROWSINESSNAUSEAAKATHISIAANXIETYDIZZINESSDYSPHAGIADYSTONIAEXTRAPYRAMIDAL

DISORDERPARKINSONISMPARKINSON'S SYNDROMESALIVA INCREASEDTREMORWEAKNESS GENERALIZED

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⌫ ⌦

SKIN AND APPENDAGES DISORDERSBODY AS A WHOLE - GENERAL DISORDERSGASTRO-INTESTINAL SYSTEM DISORDERSAUTONOMIC NERVOUS SYSTEM DISORDERSRESPIRATORY SYSTEM DISORDERSMETABOLIC AND NUTRITIONAL DISORDERSCARDIOVASCULAR DISORDERS, GENERALCENTRAL & PERIPHERAL NERVOUS SYST. DISORDERSURINARY SYSTEM DISORDERSHEART RATE AND RYTHM DISORDERSLIVER AND BILIARY SYSTEM DISORDERSMUSCULO-SKELETAL SYSTEM DISORDERSPSYCHIATRIC DISORDERSVASCULAR (EXTRACARDIAC) DISORDERSPLATELET, BLEEDING AND CLOTTING DISORDERSVISION DISORDERSRED BLOOD CELL DISORDERSAPPLICATION SITE DISORDERSRESISTANCE MECHANISM DISORDERSWHITE BLOOD CELL DISORDERSREPRODUCTIVE DISORDERS, FEMALEENDOCRINE DISORDERSHEARING AND VESTIBULAR DISORDERSREPRODUCTIVE DISORDERS, MALECOLLAGEN DISORDERSMYO-, ENDO-, PERICARDIAL & VALVE DISORDERSFOETAL DISORDERSNEOPLASMSSPECIAL SENSES OTHER, DISORDERSNEONATAL AND INFANCY DISORDERS

20,1234,7292,4032,1431,7111,6861,6141,5601,060

7305383042812332051731641496745353433271996441

50.1911.805.995.354.274.214.033.892.641.821.340.760.700.580.510.430.410.370.170.110.090.080.080.070.050.020.010.010.010.00

⌦ ⌫⌦⌫⌫ ⌦⌦ ⌫⌫⌫

40,090 100.00

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⌫ ⌦

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⌫ ⌦ ⌦⌦ ⌦ ⌫

⌫ ⌦

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⌫⌦⌫ ⌫⌫ ⌫⌫ ⌫

⌫ ⌦⌫⌫⌦

2528 295 1. Systemic general antiinfectives (57.53%)• Systemic Antibiotics (59.88%)• Systemic Chemotherapeutics (19.19%)• Tuberclostatics excl. streptomycin

(16.72%)2. Central nervous system drugs (16.72%)

• Analgesics (62.00%)

3. Various (9.70%)• Diagnostic Agents (100%)

1. Skin and appendages disorders (25.43%)• Pruritus (35.50%)• Rash (25.24%)• Rash Erythematous (17.48%)

2. Gastro-intestinal System Disorders (18.02%)• Vomiting (28.77%)• Nausea (23.29%)• Haematemesis (10.27%)

3. Body as a whole-general disorders (11.0%)• Face oedema (15.96%)• Abdominal pain (14.89%)• Fever (9.57%)

2527 234 1. Systemic general antiinfectives (61.51%)• Systemic Antibiotics (69.68%)• Systemic Chemotherapeutics (17.42%)• Tuberclostatics excl. streptomycin

(10.97%)2. Central nervous system drugs (18.25%)

• Analgesics (71.74%)

3. Allimentary tract and metabolism drugs (4.76%)• Gastrointestinal antispasmodics and

anticholinergics (13.04%)

1. Skin and appendages disorders (33.43%)• Pruritus (35.90%)• Rash (28.21%)• Rash Erythematous (10.30%)

2. Gastro-intestinal System Disorders (13.14%)• Nausea (20.65%)• Vomiting (20.65%)• Malaena (17.39%)

3. Body as a whole-general disorders (11.0%)• Chest pain (23.38%)• Fever (16.88%)• Syncope (12.99%)

2526 176 1. Antibiotics (47%)2. Antituberculostatics (7.9%)

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Spontaneous Report of Adverse Drug Reaction 2004 229

2529

2530

2531

243

330

658

1. General anti-infective for systemic use (58.06%)• Systemic Antibiotics (43.75%)• Tuberclostatics excl. streptomycin (37.03%)• Systemic Chemotherapeutics (19.44%)

2. Central nervous system drugs (16.72%)• Analgesics (77.78%)

3. Musculo-skeletal system (7.26%)• Anti-inflammatory & antirheumatics

(44.15%)

1. General anti-infective for systemic use (59.9%)• Systemic Antibiotics (55.3%)• Systemic Chemotherapeutics (21.4%)• Tuberclostatics excl. streptomycin (19.9%)

2. Central nervous system drugs (14.5%)• Analgesics (88.8%)

3. Allimentary tract and metabolism drugs (6.7%)• Gastrointestinal antispasmodics and

anticholinergics (60.9%)

1. General anti-infective for systemic use (54.8%)• Systemic Antibiotics (62.9%)• Systemic Chemotherapeutics (19.7%)• Tuberclostatics excl. streptomycin (13.0%)

2. Central nervous system drugs (12.7%)• Analgesics (77.5%)

3. Musculo-skeletal system (9.0%)• Anti-inflammatory & antirheumatics

(80.4%)

1. Skin and appendages disorders (24.19%)• Pruritus (33.33%)• Rash (26.28%)• Rash Erythematous (16.66%)

2. Gastro-intestinal System Disorders (14.42%)• Vomiting (23.66%)• Nausea (19.35%)• Stomatitis (8.60%)

3. Body as a whole-general disorders (12.09%)• Face oedema (15.38%)• Oedema (14.10%)• Syncope (11.54%)

1. Skin and appendages disorders (32.67%)• Pruritus (34.68%)• Rash (29.29%)• Rash Erythematous (15.49%)

2. Gastro-intestinal System Disorders (12.11%)• Vomiting (23.85%)• Nausea (17.43%)• Malaena (14.68%)

3. Body as a whole-general disorders (12.00%)• Face oedema (12.96%)• Abdominal pain (12.04%)• Anaphylactoid shock (10.19%)

1. Skin and appendages disorders (41.21%)• Pruritus (39.03%)• Rash (32.45%)• Rash Erythematous (13.64%)

2. Body as a whole-general disorders (12.08%)• Face oedema (19.25%)• Fever (13.90%)• Chest pain (12.83%)

3. Gastro-intestinal System Disorders (12.11%)• Vomiting (30.00%)• Nausea (29.38%)• Stomatitis (20.63%)

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2532

2533

2534

663

743

963

1. General anti-infective for systemic use (60.8%)• Systemic Antibiotics (63.9%)• Systemic Chemotherapeutics (20.1%)• Tuberclostatics excl. streptomycin (13.3%)

2. Central nervous system drugs (10.6%)• Analgesics (63.2%)

3. Musculo-skeletal system (9.0%)• Anti-inflammatory & antirheumatics

(84.6%)

1. Systemic general antiinfectives (54.0%)• Systemic Antibiotics (60.2%)• Systemic Chemotherapeutics (27.1%)• Tuberclostatics excl. streptomycin (9.0%)

2. Central nervous system drugs (13.5%)• Analgesics (68.5%)

3. Musculo-skeletal system (9.8%)• Anti-inflammatory & antirheumatics

(70.6%)

1. General anti-infective for systemic use (55.1%)• Systemic Antibiotics (62.6%)• Systemic Chemotherapeutics (27.2%)• Tuberclostatics excl. streptomycin (7.9%)

2. Central nervous system drugs (14.9%)• Analgesics (61.7%)

3. Musculo-skeletal system (9.5%)• Anti-inflammatory & antirheumatics

(79.6%)

1. Skin and appendages disorders (44.70%)• Pruritus (38.02%)• Rash (33.20%)• Rash Erythematous (12.81%)

2. Body as a whole-general disorders (12.09%)• Chest pain (17.71%)• Face oedema (16.00%)• Oedema (15.43%)

3. Gastro-intestinal System Disorders (9.42%)• Stomatitis (20.63%)• Nausea (22.22%)• Vomiting (18.95%)

1. Skin and appendages disorders (43.62%)• Pruritus (36.23%)• Rash (27.80%)• Rash Erythematous (19.25%)

2. Gastro-intestinal System Disorders (9.96%)• Vomiting (22.2%)• Nausea (20.47%)• Chelittis (15.79%)

3. Body as a whole-general disorders (9.20%)• Face oedema (18.99%)• Chest pain (18.35%)• Oedema (9.50%)

1. Skin and appendages disorders (41.85%)• Pruritus (36.95%)• Rash (33.57%)• Rash Erythematous (15.14%)

2. Body as a whole-general disorders (12.55%)• Face oedema (15.95%)• Chest pain (13.95%)• Headache (10.96%)

3. Gastro-intestinal System Disorders (8.59%)• Vomiting (22.82%)• Nausea (19.90%)• Abdominal pain (13.60%)

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Spontaneous Report of Adverse Drug Reaction 2004 231

2535

2536

2537

1,250

2,303

3,360

1. General anti-infective for systemic use (61.3%)• Systemic Antibiotics (60.4%)• Systemic Chemotherapeutics (28.8%)• Tuberclostatics excl. streptomycin (9.7%)

2. Musculo-skeletal system (9.6%)• Anti-inflammatory & antirheumatics

(79.2%)3. Central nervous system drugs (9.5%)

• Analgesics (61.7%)

1. General anti-infective for systemic use (54.55%)• Systemic Antibiotics (62.06%)• Systemic Chemotherapeutics (25.77%)• Tuberclostatics excl. streptomycin (7.94%)

2. Musculo-skeletal system (11.32%)• Antiinflammatory & antirheumatics (80.00%)

3. Central nervous system drugs (10.86%)• Analgesics (52.27%)

1. General anti-infective for systemic use (52.02%)• Systemic Antibiotics (66.22%)• Systemic Chemotherapeutics (22.52%)• Tuberclostatics excl. streptomycin (7.46%)

2. Antiparasitics product (11.31%)• Antiprotozoal (98.23%)

3. Central nervous system drugs (9.46%)• Analgesics (58.82%)

1. Skin and appendages disorders (45.60%)• Pruritus (33.83%)• Rash (31.98%)• Rash Erythematous (16.58%)

2. Body as a whole-general disorders (12.42%)• Chest pain (19.29%)• Face oedema (16.85%)• Oedema (8.40%)

3. Gastro-intestinal System Disorders (9.89%)• Cheilitis (24.91%)• Vomiting (22.18%)• Nausea (21.84%)

1. Skin and appendages disorders (43.39%)• Pruritus (30.87%)• Rash (27.64%)• Rash Maculo-papular (12.84%)

2. Body as a whole-general disorders (11.78%)• Face oedema (22.48%)• Chest pain (15.10%)• Oedema (10.40%)

3. Gastro-Intestinal System Disorders (10.65%)• Vomiting (31.75%)• Nausea (23.38%)• Cheilitis (20.96%)

1. Skin and appendages disorders (40.15%)• Pruritus (32.81%)• Rash (28.44%)• Rash Erythematous (11.20%)

2. Body as a whole-general disorders (11.97%)• Headache (20.04%)• Face oedema (19.54%)• Chest pain (14.56%)

3. Gastro-intestinal System Disorders (10.60%)• Nausea (25.11%)• Vomiting (22.86%)• Cheilitis (10.47%)

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2538

2539

2540

3,901

4,490

4,667

1. General anti-infective for systemic use (51.71%)• Systemic Antibiotics (59.48%)• Systemic Chemotherapeutics (26.90%)• Tuberclostatics excl. streptomycin (9.64%)

2. Antiparasitics product (15.65%)• Antiprotozoal (93.70%)

3. Central nervous system drugs (9.85%)• Analgesics (80.86%)

1. Antiparasitics product (54.51%)• Antiprotozoal (99.73%)• Anthelmintics (0.27%)

2. General anti-infective for systemic use (25.42%)• Systemic Antibiotics (59.04%)• Systemic Chemotherapeutics (27.36%)• Tuberclostatics excl. streptomycin (8.75%)

3. Musculo-skeletal system (11.32%)• Anti-inflammatory & antirheumatics

(84.28%)• Muscle relaxants (8.11%)• Antigout preparation (5.65%)

1. General anti-infective for systemic use (55.60%)• Systemic Antibiotics (63.50%)• Systemic Chemotherapeutics (24.58%)• Tuberclostatics excl. streptomycin (7.98%)

2. Musculo-skeletal system (12.16%)• Anti-inflammatory & antirheumatics

(82.96%)• Antigout preparation (7.23%)• Muscle relaxants (5.95%)

3. Central nervous system drugs (8.93%)• Analgesics (55.58%)• Antiepileptics (18.60%)• Psycholeptics (10.72%)

1. Skin and appendages disorders (36.51%)• Pruritus (30.89%)• Rash (25.64%)• Rash Erythematous (14.41%)

2. Body as a whole-general disorders (13.51%)• Headache (19.65%)• Face oedema (16.30%)• Chest pain (11.86%)

3. Gastro-intestinal System Disorders (10.16%)• Nausea (28.07%)• Vomiting (24.01%)• Cheilitis (11.81%)

1. Skin and appendages disorders (40.15%)• Rash (29.90%)• Pruritus (24.52%)• Rash Erythematous (12.59%)

2. Central & peripheral nervous system (18.08%)• Dizziness (42.32%)• Headache (34.21%)• Agitation (11.75%)

3. Gastro-intestinal System Disorders (10.16%)• Nausea (35.64%)• Vomiting (27.30%)• Anorexia (15.55%)

1. Skin and appendages disorders (43.69%)• Rash (28.43%)• Pruritus (23.48%)• Rash Erythematous (12.26%)

2. Body as a whole-general disorders (12.84%)• Face oedema (11.44%)• Oedema (11.44%)• Headache (8.56%)

3. Gastro-intestinal System Disorders (9.89%)• Nausea (26.83%)• Vomiting (25.03%)• Stomatitis (71.89%)

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Spontaneous Report of Adverse Drug Reaction 2004 233

2541

2542

2543

7,210

10,720

12,040

1. General anti-infective for systemic use (53.50%)• Systemic Antibiotics (58.44%)• Systemic Chemotherapeutics (24.41%)• Antimycobacterials (6.84%)

2. Musculo-skeletal system (11.42%)• Anti-inflammatory & antirheumatics

(78.99%)• Other drugs for disorders of the

Musculo-Skeletal system (7.64%)• Antigout preparations (6.74%)

3. Central nervous system drugs (9.99%)• Analgesics (47.17%)• Antiepileptics (23.01%)• Psycholeptics (8.23%)

1. General anti-infective for systemic use (48.15%)• Systemic Antibiotics (63.99%)• Systemic Chemotherapeutics (24.40%)• Antimycobacterials (8.23%)

2. Musculo-skeletal system (12.98%)• Anti-inflammatory & antirheumatics

(80.50%)• Other drugs for disorders of the

Musculo-Skeletal system (6.03%)• Antigout preparations (7.16%)

3. Central nervous system drugs (9.99%)• Analgesics (42.54%)• Antiepileptics (25.12%)• Psycholeptics (11.80%)

1. General anti-infective for systemic use (50.77%)• Systemic Antibiotics (63.56%)• Systemic Chemotherapeutics (22.07%)• Tuberclostatics excl. streptomycin (10.67%)

2. Musculo-skeletal system (12.27%)• Anti-inflammatory & antirheumatics

(80.98%)• Antigout preparations (8.34%)• Muscle relaxants (5.86%)

1. Skin and appendages disorders (39.62%)• Pruritus (24.50%)• Rash (24.30%)• Rash Erythematous (12.11%)

2. Body as a whole-general disorders (12.60%)• Face oedema (11.27%)• Oedema (10.10%)• Fever (9.70%)

3. Gastro-intestinal System Disorders (9.89%)• Nausea (30.31%)• Vomiting (25.51%)• Diarrhoea (7.82%)

1. Skin and appendages disorders (43.39%)• Rash (24.08%)• Pruritus (19.23%)• Rash Maculo-papular (12.15%)

2. Body as a whole-general disorders (11.96%)• Face oedema (13.81%)• Headache (10.25%)• Oedema periorbital (9.52%)

3. Gastro-Intestinal System Disorders (10.55%)• Vomiting (27.09%)• Nausea (26.40%)• Diarrhoea (8.03%)

1. Skin and appendages disorders (42.37%)• Pruritus (22.30%)• Rash (20.66%)• Rash Maculo-papular (13.99%)

2. Body as a whole-general disorders (12.74%)• Oedema periorbital (13.35%)• Face oedema (12.94%)• Oedema mouth (9.49%)

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2543

2544

2545

2546

12,040

16,455

17,511

17,779

3. Central nervous system drugs (9.9%)• Analgesics (48.79%)• Antiepileptics (25.40%)• Psycholeptics (11.85%)

1. General anti-infective for systemic use (51.77%)• Systemic Antibiotics (65.91%)• Systemic Chemotherapeutics (18.78%)• Tuberclostatics excl. streptomycin (8.77%)

2. Musculo-skeletal system (12.72%)• Anti-inflammatory & antirheumatics

(83.92%)• Antigout preparations (8.19%)• Muscle relaxants (4.55%)

3. Central nervous system drugs (10.31%)• Analgesics (46.40%)• Antiepileptics (24.92%)• Psycholeptics (11.95%)

1. General anti-infective for systemic use (52.02%)• Systemic Antibiotics (66.30%)• Systemic Chemotherapeutics (19.02%)• Tuberclostatics excl. streptomycin (9.02%)

2. Musculo-skeletal system (12.85%)• Anti-inflammatory & antirheumatics

(86.64%)• Antigout preparations (6.64%)• Muscle relaxants (5.29%)

3. Central nervous system drugs (10.71%)• Analgesics (47.91%)• Antiepileptics (24.47%)• Anti-parkinson drugs (10.19%)

1. General anti-infective for systemic use (52.68%)• Systemic Antibiotics (67.26%)• Systemic Chemotherapeutics (18.37%)• Tuberclostatics excl. streptomycin (7.28%)

3. Gastro-intestinal System Disorders (8.75%)• Nausea (28.32%)• Vomiting (25.86%)• Diarrhoea (7.14%)

1. Skin and appendages disorders (42.37%)• Pruritus (22.30%)• Rash (20.66%)• Rash Maculo-papular (13.99%)

2. Body as a whole-general disorders (12.74%)• Oedema periorbital (13.35%)• Face oedema (12.94%)• Oedema mouth (9.49%)

3. Gastro-intestinal System Disorders (8.75%)• Nausea (28.32%)• Vomiting (25.86%)• Diarrhoea (7.14%)

1. Skin and appendages disorders (46.24%)• Rash (22.66%)• Pruritus (21.83%)• Rash Maculo-papular (13.98%)

2. Body as a whole-general disorders (11.21%)• Face oedema (16.44%)• Oedema periorbital (15.87%)• Oedema mouth (10.99%)

3. Gastro-intestinal System Disorders (8.11%)• Nausea (26.87%)• Vomiting (25.78%)• Mouth dry (11.61%)

1. Skin and appendages disorders (49.37%)• Rash (24.50%)• Pruritus (21.05%)• Rash Maculo-papular (14.66%)

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Spontaneous Report of Adverse Drug Reaction 2004 235

2546

2547

17,779

18,812

2. Musculo-skeletal system (14.41%)• Anti-inflammatory & antirheumatics

(85.50%)• Muscle relaxants (6.80%)• Antigout preparations (6.63%)

3. Central nervous system drugs (11.88%)• Analgesics (45.55%)• Antiepileptics (28.11%)• Psycholeptics (12.30%)

1. General anti-infective for systemic use (54.98%)• Systemic Antibiotics (65.58%)• Systemic Chemotherapeutics (17.49%)• Tuberclostatics excl. streptomycin (5.62%)

2. Musculo-skeletal system (14.37%)• Anti-inflammatory & antirheumatics

(85.40%)• Muscle relaxants (7.15%)• Antigout preparations (6.86%)

3. Central nervous system drugs (13.19%)• Analgesics (36.46%)• Antiepileptics (25.00%)• Psycholeptics (17.99%)

2. Body as a whole-general disorders (12.16%)• Oedema periorbital (18.04%)• Face oedema (17.08%)• Oedema mouth (9.67%)

3. Gastro-intestinal System Disorders (6.45%)• Nausea (30.51%)• Vomiting (28.44%)• Diarrhoea (6.08%)

1. Skin and appendages disorders (50.19%)• Rash (24.15%)• Pruritus (17.59%)• Urticaria (14.20%)

2. Body as a whole-general disorders (11.80%)• Face oedema (20.34%)• Oedema periorbital (13.83%)• Oedema mouth (12.77%)

3. Gastro-intestinal System Disorders (5.88%)• Nausea (29.55%)• Vomiting (28.17%)• Diarrhoea (6.87%)

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Spontaneous Report of Adverse Drug Reaction 2004 239

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⌦240

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Spontaneous Report of Adverse Drug Reaction 2004 241

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Spontaneous Report of Adverse Drug Reaction 2004 243

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Spontaneous Report of Adverse Drug Reaction 2004 245

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Spontaneous Report of Adverse Drug Reaction 2004 247

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Spontaneous Report of Adverse Drug Reaction 2004 249

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Spontaneous Report of Adverse Drug Reaction 2004 251

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⌦254

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