FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed ReportSelection Criteria:

Active Ingredient:

Product Name: FDA Received Date: MedDRA Version* : Total Cases**: Number of Pages:

.;ALUMINUM HYDROXIDE\HOMATROPINE\MAGNESIUM TRISILICATE\PHENYLBUTAZONE \PREDNISONE;ASPIRIN\PREDNISONE;BLEOMYCIN SULFATE\CYCLOPHOSPHAMIDE \DOXORUBICIN\ETOPOSIDE\METHOTREXATE\PREDNISONE\VINCRISTINE;BLEOMYCIN SULFATE\CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE\VINCRISTINE;CALCIUM PHOSPHATE\MAGNESIUM TRISILICATE\PREDNISONE;CETRIMONIUM BROMIDE \NAPHAZOLINE NITRATE\PHENYLEPHRINE HYDROCHLORIDE \PREDNISONE;CETRIMONIUM BROMIDE\NAPHAZOLINE NITRATE\PHENYLEPHRINE \PREDNISONE;CISPLATIN\CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE \VINCRISTINE;CYCLOPHOSPHAMIDE\DOXORUBICIN\PREDNISONE;CYCLOPHOSPHAMIDE \DOXORUBICIN\PREDNISONE\RITUXIMAB\VINCRISTINE;CYCLOPHOSPHAMIDE \DOXORUBICIN\PREDNISONE\VINCRISTINE;CYCLOPHOSPHAMIDE\DOXORUBICIN \PREDNISONE\VINCRISTINE SULFATE;CYCLOPHOSPHAMIDE\MITOXANTRONE \PREDNISONE\VINCRISTINE;INDOMETHACIN\PREDNISONE;NEOMYCIN \PREDNISONE;PREDNISOLONE SODIUM SUCCINATE\PREDNISONE;PREDNISOLONE \PREDNISONE;PREDNISONE;PREDNISONE ACETATE;PREDNISONE\PREDNISONE ACETATE;PREDNISONE\UNSPECIFIED INGREDIENT . From: 01-JAN-2012 To: 15.1 4,352 2,627 05-FEB-2013

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed ReportDisclaimer: Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events. *. MedDRA Version refers to the name and version of the dictionary in use at the time the cases were retrieved from the FDA Adverse Event Reporting System (FAERS). MedDRA Medical Dictionary for Regulatory Activities (MedDRA) is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products. A MedDRA Preferred Term (PT) is used to standardize a medical concept in a report. For example, a report of heart attack or myocardial infarct are standardized to the same Preferred Term, Myocardial Infarction. MedDRA is updated twice a year. **. Total Cases reflects the number of individual patient case reports associated with the product of interest that were submitted to FDA within the specified time period. A case consists of an initial report and any follow-up reports submitted to FDA. Because FDA may receive reports on the same patient from more than one source, some of these cases may be duplicate patient reports.

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed ReportThe information in this report is generated from the FDA Adverse Event Reporting System (FAERS) by using a report query where suspect product(s) or active ingredients are selected from a standardized dictionary and a date range is specified as search criteria. The table below provides the definitions for field headings that are listed on the report.

FAERS data have limitations, including the following. There is no certainty that the reported event was actually due to the product. Reports are often incomplete - a blank field means that no data were provided. FDA does not receive reports on all adverse events that occur with a product. Many factors can influence whether or not an event will be reported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population.

Field Heading Definition FDA Received Date The date that FDA received the most recent information regarding a case, either as an initial report or follow-up report. The FDA Received Date may not be the same as the date that the event occurred. The event may have occurred days or even months (or years) before the report was sent to (and received by) FDA. Note the displayed date on the report may be later than the query date range if FDA received follow-up information for a case. FDA provides the most current case information available. Case # A unique number assigned by FDA that identifies a FAERS case. A case includes the information received in the initial report plus any additional information received in follow-up reports. Case Type There are three case types in FAERS: Expedited (15-Day): submitted to FDA by manufacturers; these are reports containing serious, unexpected adverse events Nonexpedited: submitted periodically to FDA by manufacturers; these are reports containing adverse events other than those qualifying for expedited (15-day) reporting Direct: submitted directly to FDA by healthcare professionals, patients and other consumers Indicates whether the initial source who provided information about the event is a health professional (HP). Possible values are; Y - Yes, N No or the field is blank if it was not reported Based on FDA regulations, the reported outcome(s) determines whether a case is serious. The outcome categories include congenital anomaly/birth defect (CA), death (DE), disability (DS), hospitalization (HO), life-threatening (LT), other serious important medical event (OT), and required intervention to prevent permanent impairment/damage (RI). A case can have more than one outcome. The Manufacturer Control Number is the manufacturers unique identifier associated with the case. Also referred to as the Company Report Number. The patient's age, with age unit, based on information provided in the report. Patient sex (Male, Female, Unknown). The country where the event occurred. If not reported, then the country of the reporter. The International Organization for Standardization (ISO) 3166-1 alpha-3 country code is used as an abbreviation for the country.

Health Professional Outcomes

Manufacturer Control # Age Sex Country

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed ReportField Heading Preferred Term Definition A Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term (PT) is used to standardize a medical concept in a report. For example, a report of heart attack or myocardial infarct are standardized to the same Preferred Term, Myocardial Infarction. MedDRA is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products Name of a drug or therapeutic biologic in the case report. A product name can appear as either a brand name (trade name) or an active ingredient name, depending on what was reported. There are two roles for products listed on the cases. Suspect (S) identifies the product(s) that the initial reporter deemed most likely to be associated with the event. Concomitant (C) identifies products taken at the same time as the suspect product, but not deemed by the initial reporter as being associated with the event. Reported route of product administration (e.g., oral, topical, injection, sublingual, inhalation). Refers to the amount of the product that was taken or given to a patient, and the frequency of administration. For example, 20 mg twice daily. The length of time the product was used. For example, if someone reported taking Drug A from January 1 to January 30, the duration would be 30 days. The manufacturer of the product, as indicated in the report.

Product Role

Route Dosage Text Duration Manufacturer

8289764 FDA Received Date02-Jan-2012

Case # 8289764

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # BR-BRISTOL-MYERS SQUIBB COMPANY-16275158 Dosage Text 12Jul11

Age 46 YR

Sex Male

Country BRA

Preferred Term PNEUMOCYSTIS JIROVECI PNEUMONIA

Product BELATACEPT PREDNISONE AZATHIOPRINE

Role Route S S C INTRAVENOUS

Duration

Manufacturer

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8314964 FDA Received Date02-Jan-2012 Case # 8314964 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # US-PFIZER INC-2011311328 Dosage Text UNK UNK UNK UNK UNK UNK UNK UNK UNK Manufacturer Control # FR-ROCHE-1024335 Dosage Text Duration Age Sex Male Country FRA Manufacturer Age 59 YR Sex Female Country USA

Preferred Term COMPLETED SUICIDE

Product ALPRAZOLAM HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARBAMAZEPINE ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE PREDNISONE OMEPRAZOLE

Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Duration

Manufacturer PFIZER

8317776 FDA Received Date02-Jan-2012 Preferred Term HEPATITIS FULMINANT LIVER TRANSPLANT HEPATITIS B

Case # 8317776

Case Type EXPEDITED (15-DAY) Product RITUXIMAB ONCOVIN

Health Professional Y

Outcomes HO,DS,LT Role Route S S S S S C INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL INTRAVENOUS ORAL

ADRIAMYCIN PREDNISONE CYCLOPHOSPHAMIDE KETEK

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8317918 FDA Received Date02-Jan-2012 Preferred Term SEPSIS COCCIDIOIDOMYCOSIS URINARY TRACT INFECTION PYELONEPHRITIS ABSCESS APPENDICITIS BRONCHOPULMONARY ASPERGILLOSIS CELLULITIS CHOLECYSTITIS INFECTIVE DIVERTICULITIS HERPES ZOSTER INFECTIOUS PERITONITIS INFLUENZA PNEUMONIA Case # 8317918 Case Type EXPEDITED (15-DAY) Product RITUXIMAB CELLCEPT PREDNISONE HUMAN IMMUNOGLOBULIN G Health Professional Y Outcomes DE,OT Role Route S S S S Manufacturer Control # US-ROCHE-1026003 Dosage Text 3 weeks before transplant Duration Age Sex Unknown Country USA

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7665407 FDA Received Date03-Jan-2012 Case # 7665407 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USJNJFOC-20100806515 Dosage Text Age 60 YR Sex Male Country USA

Preferred Term TENDON RUPTURE IMPAIRED HEALING FOOT DEFORMITY ASTHENIA DEPRESSION HYPOTONIA IMMOBILE LUNG DISORDER WEIGHT DECREASED WOUND

Product LEVAQUIN LEVAQUIN PREDNISONE

Role Route S S S ORAL ORAL UNKNOWN

Duration

Manufacturer

8167047 FDA Received Date03-Jan-2012

Case # 8167047

Case Type NON-EXPEDITED

Health Professional Y

Outcomes HO

Manufacturer Control # CHJNJFOC-20110901233 Dosage Text

Age 69 YR

Sex Male

Country CHE

Preferred Term MUSCULAR WEAKNESS TUMOUR PAIN

Product ABIRATERONE ACETATE ABIRATERONE ACETATE PREDNISONE FENTANYL ABSTRAL LODINE METAMIZOLE SODIUM PERINDOPRIL ERBUMINE TORSEMIDE GLICLAZIDE

Role Route S S S C C C C C C C Health Professional Y ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Duration

Manufacturer

8254341 FDA Received Date03-Jan-2012

Case # 8254341

Case Type EXPEDITED (15-DAY)

Outcomes HO

Manufacturer Control # DKJNJFOC-20111104691

Age 64 YR

Sex Male

Country DNK

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8254341Preferred Term FEBRILE NEUTROPENIA PNEUMONIA PYREXIA PULMONARY EMBOLISM MUSCLE RUPTURE PLEURAL EFFUSION HAEMOGLOBIN DECREASED BLOOD CREATININE INCREASED BLOOD PHOSPHORUS INCREASED WHITE BLOOD CELL COUNT DECREASED COAGULATION TIME PROLONGED INTERNATIONAL NORMALISED RATIO DECREASED Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE NEUPOGEN NEUPOGEN NEUPOGEN PREDNISONE PREDNISONE PREDNISONE RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE ACYCLOVIR ALLOPURINOL AMLODIPINE ENOXAPARIN SODIUM FUROSEMIDE LACTULOSE LANSOPRAZOLE MORPHINE MOVIPREP SENNOSIDE Role Route S S S S S S S S S S S S S S S S S S S S C C C C C C C C C C INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS ORAL ORAL ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL UNKNOWN UNKNOWN Dosage Text Duration Manufacturer

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8254341Preferred Term Product SULFAMETHOXAZOL AND TRIMETHOPRIM MORPHINE SULFATE Role Route C C ORAL UNKNOWN Manufacturer Control # PLJNJFOC-20111111259 Age 58 YR Sex Female Country POL Dosage Text Duration Manufacturer

8266018 FDA Received Date03-Jan-2012

Case # 8266018

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8266018Preferred Term INTERSTITIAL LUNG DISEASE FEBRILE NEUTROPENIA Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE PREDNISONE PREDNISONE PREDNISONE PREDNISONE PREDNISONE PREDNISONE Role Route S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN Dosage Text cycle 1 cycle 2 cycle 3 cycle 4 cycle 5 cycle 6 cycle 6 cycle 5 cycle 4 cycle 3 cycle 1 cycle 2 cycle 1 cycle 6 cycle 5 cycle 4 cycle 3 cycle 2 cycle 5 cycle 6 cycle 4 cycle 3 cycle 2 cycle 1 cycle 6 cycle 5 cycle 4 cycle 3 cycle 2 cycle 1 Duration Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8316067 FDA Received Date03-Jan-2012 Case # 8316067 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # USABBOTT-11P-163-08870 51-00 Dosage Text Age 41 YR Sex Female Country USA

Preferred Term CONVULSION PETIT MAL EPILEPSY JAUNDICE LIVER INJURY ANAESTHETIC COMPLICATION HYPOAESTHESIA GAIT DISTURBANCE LIVER TRANSPLANT REJECTION ARTHRALGIA ARTHROPATHY GRAND MAL CONVULSION HEPATIC FAILURE JOINT SWELLING PYREXIA RASH RENAL FAILURE VOMITING

Product DEPAKOTE DEPAKOTE LAMICTAL LAMICTAL PREDNISONE NEURONTIN UNSPECIFIED INGREDIENT ZOLOFT

Role Route S S S S S S S C

Duration

Manufacturer

8318333 FDA Received Date03-Jan-2012

Case # 8318333

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes DE,HO

Manufacturer Control # CHJNJFOC-20111212139 Dosage Text

Age 72 YR

Sex Female

Country CHE

Preferred Term SEPTIC SHOCK MYOCARDIAL INFARCTION

Product REMICADE PREDNISONE NOVOLOG MIX 70/30 NEXIUM METOPROLOL TARTRATE

Role Route S S C C C INTRAVENOUS UNKNOWN SUBCUTANEOUS UNKNOWN UNKNOWN

Duration

Manufacturer

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Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8318909 FDA Received Date03-Jan-2012 Case # 8318909 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # DE-PFIZER INC-2011309775 Dosage Text 25 mg/m2 25 mg/m2 ORAL ORAL INTRAVENOUS INTRAVENOUS ORAL 40 mg/m2 40 mg/m2, UNK 375 mg/m2 375 mg/m2 10 mg/m2 100 mg/m2 100 mg/m2 INTRAVENOUS INTRAVENOUS INTRAVENOUS 100 mg/m2 100 mg/m2 650 mg/m2 Manufacturer Control # JPWATSON-2011-22280 Dosage Text 60 mg/m2, unknown UNK UNK Age 28 YR Sex Female Country JPN Age 19 YR Sex Female Country DEU

Preferred Term PRESYNCOPE SEPSIS PYREXIA CHILLS IRON DEFICIENCY ANAEMIA FEBRILE NEUTROPENIA UROSEPSIS

Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE PREDNISONE PREDNISONE RITUXIMAB RITUXIMAB BLEOMYCIN SULFATE PROCARBAZINE HYDROCHLORIDE PROCARBAZINE HYDROCHLORIDE ETOPOSIDE ETOPOSIDE CYCLOPHOSPHAMIDE

Role Route S S S S S S S S S S S S INTRAVENOUS

Duration

Manufacturer PFIZER PFIZER

8319957 FDA Received Date03-Jan-2012

Case # 8319957

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Preferred Term POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME

Product PREDNISONE ELSPAR VINCRISTINE SULFATE

Role Route S S S UNKNOWN

Duration

Manufacturer WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8320016 FDA Received Date03-Jan-2012 Case # 8320016 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USWATSON-2011-22406 Dosage Text Age 14 YR Sex Male Country USA

Preferred Term CHRONIC GRAFT VERSUS HOST DISEASE DRUG INEFFECTIVE MYOPATHY OSTEONECROSIS

Product PREDNISONE TACROLIMUS SIROLIMUS

Role Route S S S

Duration

Manufacturer WATSON WATSON

8320081 FDA Received Date03-Jan-2012

Case # 8320081

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # USWATSON-2011-22590 Dosage Text 50 mg every other day

Age 68 YR

Sex Male

Country USA

Preferred Term FOOT FRACTURE STRESS FRACTURE

Product PREDNISONE PAMIDRONATE DISODIUM ZOLEDRONIC ACID

Role Route S S S Outcomes DE,OT ORAL

Duration

Manufacturer WATSON

7816001 FDA Received Date04-Jan-2012

Case # 7816001

Case Type EXPEDITED (15-DAY)

Health Professional Y

Manufacturer Control # BE-CELGENEUS-013C5013-11021332 Dosage Text 10 Milligram .18 milligram/kilogram 2 milligram/kilogram

Age 78 YR

Sex Male

Country BEL

Preferred Term TRANSITIONAL CELL CARCINOMA

Product LENALIDOMIDE MELPHALAN HYDROCHLORIDE PREDNISONE

Role Route S S S ORAL ORAL ORAL

Duration 3 YEAR 225 DAY 225 DAY

Manufacturer CELGENE

Date - Time: 02-05-2013 11:11:44 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8191076 FDA Received Date04-Jan-2012 Case # 8191076 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # FR-PFIZER INC-2011244366 Dosage Text 200 mg, 2x/day UNK UNK UNK UNK UNK UNKNOWN Age 60 YR Sex Male Country FRA

Preferred Term ACTINIC KERATOSIS PHOTOSENSITIVITY REACTION

Product VFEND PREDNISONE NEORAL GLEEVEC SPIRIVA VALACYCLOVIR HYDROCHLORIDE CALCIUM CARBONATE CEFPODOXIME PROXETIL

Role Route S S S C C C C C Outcomes HO Role Route S S S S S S C C ORAL ORAL ORAL ORAL

Duration 86 DAY 207 DAY 1.2 YEAR

Manufacturer PFIZER

8320897 FDA Received Date04-Jan-2012 Preferred Term SUBILEUS ABDOMINAL PAIN ARTHRALGIA

Case # 8320897

Case Type EXPEDITED (15-DAY) Product TASIGNA ONCOVIN

Health Professional Y

Manufacturer Control # PHHY2012FR000475 Dosage Text 2 DF, BID

Age 31 YR Duration

Sex Female

Country FRA

Manufacturer

CYCLOPHOSPHAMIDE VINCRISTINE SULFATE PREDNISONE DEXAMETHASONE ZOLPIDEM KEPPRA

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8321007 FDA Received Date04-Jan-2012 Preferred Term DEEP VEIN THROMBOSIS Case # 8321007 Case Type EXPEDITED (15-DAY) Product PREDNISONE PREDNISONE MYCOPHENOLATE SODIUM MYCOPHENOLATE SODIUM TACROLIMUS Health Professional N Outcomes HO,OT Role Route S S S S C ORAL ORAL ORAL ORAL ORAL Manufacturer Control # PHHO2011BR021779 Dosage Text 7.5 mg, QD 5 mg, QD 720 mg, BID 1080 mg, QD 2 mg, BID Manufacturer Control # PHHO2011US00479 Dosage Text 7.5 mg, BID 5 mg, QD 1000 mg, BID 3 mg AM, 4 mg PM 3 mg, BID Age 46 YR Duration Sex Female Country USA Age 53 YR Duration 137 DAY Sex Male Country BRA Manufacturer

8321012 FDA Received Date04-Jan-2012 Preferred Term COLITIS GASTROENTERITIS DIARRHOEA

Case # 8321012

Case Type EXPEDITED (15-DAY) Product

Health Professional N

Outcomes HO Role Route S S S S S ORAL ORAL ORAL ORAL ORAL

Manufacturer

PREDNISONE PREDNISONE MYCOPHENOLATE MOFETIL PROGRAF PROGRAF

Date - Time: 02-05-2013 11:11:44 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8321813 FDA Received Date04-Jan-2012 Case # 8321813 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # BRABBOTT-11P-020-08872 30-00 Dosage Text Duration Age Sex Unknown Country BRA

Preferred Term INFECTION HEART RATE INCREASED ARRHYTHMIA BLOOD PRESSURE INCREASED TREMOR FUNGAL INFECTION OROPHARYNGEAL PAIN SOMNOLENCE ASTHENIA ORAL CANDIDIASIS GAIT DISTURBANCE IMMUNODEFICIENCY COUGH DRUG PRESCRIBING ERROR

Product SYNTHROID SYNTHROID VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE UNSPECIFIED INGREDIENT METICORTEN METICORTEN METICORTEN BENZALKONIUM CHLORIDE \SODIUM CHLORIDE DIOVAN OMEPRAZOLE KAINIC ACID\SANTONIN

Role Route S S S S S S S S S C C C NASAL

Manufacturer

8322486 FDA Received Date04-Jan-2012 Preferred Term SKIN ULCER

Case # 8322486

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes HO,OT Role Route S S S S SUBCUTANEOUS

Manufacturer Control # 2011AP003011 Dosage Text 5 MG;QD 25 MG;SC;QW

Age 67 YR Duration

Sex Male

Country CAN Manufacturer

DICLOFENAC SODIUM PREDNISONE METHOTREXATE ABATACEPT

SMALL INTESTINAL OBSTRUCTION BONE MARROW FAILURE OSTEOPENIA DRUG INTERACTION

8439293 FDA Received Date04-Jan-2012

Case # 8439293

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # 2011HGS-002668

Age 70 YR

Sex Female

Country USA

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8439293Preferred Term GASTRITIS EROSIVE GASTROOESOPHAGEAL REFLUX DISEASE OESOPHAGITIS ULCERATIVE OESOPHAGEAL ULCER HAEMORRHAGE Product BENLYSTA CELLCEPT PREDNISONE EXFORGE (AMLODIPINE W/ VALSARTAN) (AMLODIPINE, VALSARTAN) ZETIA PAIXL (PAROXETINE HYDROCHLORIDE) (PAROXETINE HYDROCHLORIDE) FLEXERIL (CYCLOBENZAPRINE HYDROCHLORIDE) (CYCLOBENZAPRINE HYDROCHLORIDE) NEXIUM FISH OIL (FISH OIL) (FISH OIL) MULTIVITAMIN (MULTIVITAMINS) (ERGOCALCIFEROL, ASCORBIC ACID, FOLIC ACID, THIAMINE HYDROCHLORIDE, RET CALCIUM WITH VITAMIN D (CALCIUM WITH VITAMIN D) (ERGOCALCIFEROL, CALCIUM PHOSPHATE, CALCIUM SODIUM L VITAMIN C (ASCORBIC ACID) (ASCORBIC ACID) FIORICET W/ CODEINE (FIORICET W/ CODEINE) (CODEINE PHOSPHATE, CAFFEINE, BUTALBITAL, PARACETAMOL) CARAFATE (SUCRALFATE) (SUCRALFATE) Role Route S S S C INTRAVENOUS DRIP ORAL ORAL Dosage Text 1 IN 28 D, INTRAVENOUS DRIP 2500 MG, 1 IN 1 D, ORAL 1 IN 1 D, ORAL Duration Manufacturer

OESOPHAGEAL PAIN

C C

C

C C C

C

C C

C

Date - Time: 02-05-2013 11:11:44 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8439293Preferred Term Product PRILOSEC (OMEPRAZOLE) (OMEPRAZOLE) Role Route C Dosage Text Duration Manufacturer

7898269 FDA Received Date05-Jan-2012 Preferred Term LYMPHADENOPATHY

Case # 7898269

Case Type EXPEDITED (15-DAY) Product AVASTIN

Health Professional Y

Outcomes HO Role Route S INTRAVENOUS

Manufacturer Control # CO-ROCHE-770572 Dosage Text DATE OF LAST DOSE PRIOR TO SAE: 28 MAY 2010; FORM: LIQUID FREQUENCY:ONE DOSES FORM: INFUSION (FROM PROTOCOL) ROUTE TAKEN (FROM PROTOCOL) ROUTE TAKEN (FROM PROTOCOL) ROUTE TAKEN FROM PROTOCOL DAY 1-5; EVERY 21 DAYS

Age 49 YR Duration

Sex Female

Country COL

Manufacturer

RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE PREDNISONE VERAPAMIL HYDROCHLORIDE ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE TRAMADOL HYDROCHLORIDE METOCLOPRAMIDE OMEPRAZOLE

S S S S S C C C C C C

INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 18 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8087513 FDA Received Date05-Jan-2012 Preferred Term Peripheral artery thrombosis PERIPHERAL ISCHAEMIA HAEMATOMA VOMITING Case # 8087513 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT PREDNISONE Health Professional Y Outcomes HO,DS,OT Role Route S S S Manufacturer Control # 2011SP015421 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

8286324 FDA Received Date05-Jan-2012

Case # 8286324

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes DE,HO

Manufacturer Control # KRGLAXOSMITHKLINEB0754710B Dosage Text 4MG Per day 200MG Per day 60MG Per day 80MG Per day 800MG Twice per day

Age 74 YR

Sex Unknown

Country KOR

Preferred Term ASTHENIA

Product MELPHALAN HYDROCHLORIDE THALIDOMIDE PREDNISONE ASPIRIN DIOVAN AMARYL GLIATILIN DIPYRONE

Role Route S S S C C C C C Health Professional Y UNKNOWN ORAL UNKNOWN ORAL ORAL ORAL ORAL ORAL

Duration 43 DAY 43 DAY

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE

8299503 FDA Received Date05-Jan-2012

Case # 8299503

Case Type EXPEDITED (15-DAY)

Outcomes HO

Manufacturer Control # IT-GLAXOSMITHKLINEB0770122A Dosage Text 50MG per day 50MG per day 10MG per day

Age 79 YR

Sex Female

Country ITA

Preferred Term ATRIAL FIBRILLATION ASTHENIA DYSPNOEA EXERTIONAL PULMONARY HYPERTENSION

Product PREDNISONE THALIDOMIDE ALKERAN ASPIRIN ZOMETA OMEPRAZOLE

Role Route S S C C C C ORAL ORAL ORAL

Duration 4 DAY 19 DAY 4 DAY

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 19 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8301899 FDA Received Date05-Jan-2012 Case # 8301899 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # USJNJFOC-20111206402 Dosage Text Age 28 YR Sex Male Country USA

Preferred Term WEIGHT DECREASED FAECAL INCONTINENCE HAEMATOCHEZIA DEFAECATION URGENCY INFECTION COLITIS ULCERATIVE

Product SIMPONI CIPROFLOXACIN PREDNISONE PREDNISONE ASACOL CALCIUM ACETATE IRON

Role Route S S S S C C C Health Professional Y Outcomes DE ORAL ORAL ORAL SUBCUTANEOUS

Duration

Manufacturer

8322120 FDA Received Date05-Jan-2012

Case # 8322120

Case Type EXPEDITED (15-DAY)

Manufacturer Control # US-PAR PHARMACEUTICAL, INC-2011SCPR003631 Dosage Text UNK, Unknown UNK, Unknown UNK, Unknown

Age 58 YR

Sex Female

Country USA

Preferred Term DEATH COMPLETED SUICIDE CARDIO-RESPIRATORY ARREST

Product ALPRAZOLAM OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN PREDNISONE

Role Route S S S ORAL ORAL ORAL

Duration

Manufacturer PAR

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 20 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8322121 FDA Received Date05-Jan-2012 Case # 8322121 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # US-PAR PHARMACEUTICAL, INC-2011SCPR003632 Dosage Text UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown UNK, Unknown Manufacturer Control # ES-MILLENNIUM PHARMACEUTICALS, INC.-2011-06738 Dosage Text Duration Age Sex Unknown Country ESP Age 59 YR Sex Female Country USA

Preferred Term DEATH COMPLETED SUICIDE

Product ALPRAZOLAM HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARBAMAZEPINE ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE PREDNISONE OMEPRAZOLE

Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Duration

Manufacturer PAR

8322649 FDA Received Date05-Jan-2012

Case # 8322649

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Preferred Term PANCYTOPENIA

Product VELCADE DOXORUBICIN HYDROCHLORIDE MELPHALAN HYDROCHLORIDE PREDNISONE THALIDOMIDE CYCLOPHOSPHAMIDE DEXAMETHASONE

Role Route S S S S S S S

Manufacturer MILLENNIUM

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 21 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8322651 FDA Received Date05-Jan-2012 Case # 8322651 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # ES-MILLENNIUM PHARMACEUTICALS, INC.-2011-06730 Dosage Text Duration Age Sex Unknown Country ESP

Preferred Term PANCYTOPENIA

Product VELCADE MELPHALAN HYDROCHLORIDE PREDNISONE

Role Route S S S Outcomes

Manufacturer MILLENNIUM

8323594 FDA Received Date05-Jan-2012

Case # 8323594

Case Type NON-EXPEDITED

Health Professional Y

Manufacturer Control # USABBOTT-11P-163-07176 55-00

Age 65 YR

Sex Female

Country USA

Preferred Term BLOOD PRESSURE FLUCTUATION PALPITATIONS DRUG INTERACTION EAR DISORDER

Product SYNTHROID PREDNISONE ZYRTEC

Role Route S S S ORAL ORAL ORAL

Dosage Text Every morning 1 on Saturday and 1 on Sunday Twice daily as needed

Duration

Manufacturer

8330306 FDA Received Date05-Jan-2012 Preferred Term CARDIAC FAILURE THROMBOCYTOPENIA

Case # 8330306

Case Type DIRECT Product

Health Professional Y

Outcomes HO Role Route S S S S S

Manufacturer Control #

Age 77 YR

Sex Female

Country USA

Dosage Text 5445 MG 363 MG 1500 MG 2870 MG 10 MG

Duration

Manufacturer

CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE PREDNISONE RITUXIMAB VINCRISTINE SULFATE

NEUROPATHY PERIPHERAL

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 22 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8333120 FDA Received Date05-Jan-2012 Preferred Term MUIR-TORRE SYNDROME REFUSAL OF TREATMENT BY PATIENT Case # 8333120 Case Type EXPEDITED (15-DAY) Product MYCOPHENOLATE MOFETIL PREDNISONE Case Type EXPEDITED (15-DAY) Product ENALAPRIL MALEATE HYDROCODONE BITARTRATE & ACETAMINOPHEN CARBAMAZEPINE ATENOLOL HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE ALPRAZOLAM PREDNISONE OMEPRAZOLE Health Professional Y Health Professional Y Outcomes OT Role Route S S Outcomes DE Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # MYCO20110020 Dosage Text UNK,UNK,UNKNOWN UNK,UNK,UNKNOWN Manufacturer Control # DSA_48647_2011 Dosage Text DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL Manufacturer Control # 2011P1009134 Dosage Text Duration Age Sex Female Country USA Age 59 YR Duration Sex Female Country USA Age 52 YR Duration Sex Male Country USA Manufacturer

8342015 FDA Received Date05-Jan-2012 Preferred Term COMPLETED SUICIDE

Case # 8342015

Manufacturer

8437196 FDA Received Date05-Jan-2012 Preferred Term CONVULSION

Case # 8437196

Case Type NON-EXPEDITED Product

Health Professional N

Outcomes OT Role Route S Outcomes OT Role Route S

Manufacturer

PREDNISONE Case # 8437203 Case Type NON-EXPEDITED Product PREDNISONE Health Professional N

8437203 FDA Received Date05-Jan-2012 Preferred Term

Manufacturer Control # 2011P1009112 Dosage Text

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL DISTENSION PAIN WEIGHT INCREASED

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 23 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8450911 FDA Received Date05-Jan-2012 Preferred Term PSYCHOTIC DISORDER Case # 8450911 Case Type NON-EXPEDITED Product PREDNISONE Case Type EXPEDITED (15-DAY) Product CITALOPRAM HYDROBROMIDE VALPROATE SODIUM URAPIDIL KAYEXALATE PREDNISONE CALCIUM CARBONATE RENAGEL Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes HO Role Route S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # 1000024171 Dosage Text ORAL 1000 MG (1000 MG 1 IN 1 D), ORAL 90 MG (90 MG, 1 IN 1 D), ORAL 6.4286 G (45 GM, 1 IN 1 WK) 30 MG (30 MG, 1 IN 1 D), ORAL ORAL 1 DOSAGE FORM (1 DOSAGE FORMS, 1 IN 1 D), ORAL 3.3333 MICROGRAM (100 MCG, 1 IN 1 M) SUBCUTANEOUS SUBCUTANEOUS Age 53 YR Duration Sex Male Country DNK Manufacturer Manufacturer Control # 2011P1009125 Dosage Text Duration Age Sex Male Country USA Manufacturer

8171566 FDA Received Date06-Jan-2012 Preferred Term THROMBOCYTOPENIA ANAEMIA RENAL IMPAIRMENT

Case # 8171566

ARANESP CALCIPARINE

S S

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 24 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8232358 FDA Received Date06-Jan-2012 Case # 8232358 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # FR-CELGENEUS-056C5013-11102969 Dosage Text 100 Milligram 12 Milligram 110 Milligram 100 Milligram 40000 IU (International Unit) 1600 Milligram 100 Milligram 30 milliliter 100 Milligram Manufacturer Control # DK-ROCHE-794082 Dosage Text LAST DOSE PRIOR SAE: 18 JULY 2011. LAST DOSE PRIOR TO SAE: 03 AUGUST 2011 DISCONTINUED PERMANENTLY LAST DOSE PRIOR SAE: 22 JULY 2011 LAST DOSE PRIOR TO SAE: 07 AUGUST 2011 DISCONTINUED PERMANENTLY LAST DOSE PRIOR SAE: 18 JULY 2011 Age 61 YR Duration Sex Male Country DNK Manufacturer Age 80 YR Sex Female Country FRA

Preferred Term REFRACTORY ANAEMIA WITH RINGED SIDEROBLASTS

Product THALIDOMIDE MELPHALAN HYDROCHLORIDE PREDNISONE ALLOPURINOL EPREX CLODRONATE DISODIUM LEVOTHYROXINE SODIUM DUPHALAC TRAMADOL HYDROCHLORIDE

Role Route S S S C C C C C C ORAL UNKNOWN UNKNOWN ORAL SUBCUTANEOUS ORAL ORAL ORAL ORAL

Duration 1.4 YEAR 1.3 YEAR 1.3 YEAR

Manufacturer

8255622 FDA Received Date06-Jan-2012 Preferred Term DIARRHOEA

Case # 8255622

Case Type EXPEDITED (15-DAY) Product RITUXIMAB RITUXIMAB RITUXIMAB

Health Professional

Outcomes HO Role Route S S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL ORAL INTRAVENOUS

FEBRILE NEUTROPENIA STOMATITIS WEIGHT DECREASED HYPOKALAEMIA HYPOMAGNESAEMIA ORAL CANDIDIASIS

PREDNISONE PREDNISONE PREDNISONE CYCLOPHOSPHAMIDE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 25 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8255622Preferred Term Product CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE FILGRASTIM FILGRASTIM FILGRASTIM Role Route S S S S S S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS Dosage Text LAST DOSE PRIOR TO SAE: 03 AUGUST 2011 DISCONTINUED PERMANENTLY LAST DOSE PRIOR SAE: 18 JULY 2011 LAST DOSE PRIOR TO SAE: 03 AUGUST 2011 DISCONTINUED PERMANENTLY LAST DOSE PRIOR SAE: 18 JULY 2011 LAST DOSE PRIOR TO SAE: 03 AUGUST 2011 DISCONTINUED PERMANENTLY LAST DOSE PRIOR SAE: 20 JULY 2011 LAST DOSE PRIOR TO SAE: 04 AUGUST 2011 DISCONTINUED PERMANENTLY Duration Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 26 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8259660 FDA Received Date06-Jan-2012 Case # 8259660 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # FR-GLAXOSMITHKLINEB0764063A Dosage Text 18MG per day 2.6MG per day 120MG per day Age 61 YR Sex Male Country FRA

Preferred Term BONE PAIN INFECTION

Product MELPHALAN VELCADE PREDNISONE POLYETHYLENE GLYCOLS METFORMIN HYDROCHLORIDE INSULIN HUMAN NOS FUROSEMIDE EXTENCILLINE ACETAMINOPHEN DEXAMETHASONE

Role Route S S S C C C C C C C Outcomes HO,OT ORAL INTRAVENOUS ORAL ORAL ORAL SUBCUTANEOUS INTRAVENOUS INTRAMUSCULAR

Duration 12 DAY 12 DAY 12 DAY 4 DAY

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE

2 DAY GLAXOSMITHKLINE 80MG Monthly Manufacturer Control # FRWATSON-2011-21220 Dosage Text Age 39 YR Sex Female GLAXOSMITHKLINE Country FRA

8291008 FDA Received Date06-Jan-2012

Case # 8291008

Case Type EXPEDITED (15-DAY)

Health Professional Y

Preferred Term DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE BASEDOW'S DISEASE

Product TRAMADOL HYDROCHLORIDE CEFTRIAXONE PREDNISONE PREDNISONE PREDNISONE

Role Route S S S S S UNKNOWN ORAL ORAL OTHER

Duration

Manufacturer WATSON

1 mg/kg, daily 10 mg, daily (3 months after1mg/kg/day) IV bolus prednisone followed by oral prednisone 30 mg/ dayx10 months

WATSON WATSON WATSON

VANCOMYCIN HYDROCHLORIDE GENTAMICIN SULFATE NEFOPAM

S S S

UNKNOWN UNKNOWN UNKNOWN

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 27 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8303274 FDA Received Date06-Jan-2012 Case # 8303274 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-BRISTOL-MYERS SQUIBB COMPANY-16273427 Dosage Text No of courses: 18 No of courses: 18 Number of courses: 18 05Nov2011-18Aug2011 18Aug2011-ongoing Age 65 YR Sex Male Country USA

Preferred Term SQUAMOUS CELL CARCINOMA OF SKIN ATRIAL FIBRILLATION

Product DASATINIB PLACEBO PREDNISONE

Role Route S S S ORAL ORAL ORAL

Duration

Manufacturer

DEXAMETHASONE DOCETAXEL ZOMETA LUPRON HYDROCHLOROTHIAZIDE VITAMINS NOS CALCIUM CARBONATE MOTRIN PERCOCET INFLUENZA VIRUS VACCINE NOS

S S C C C C C C C C

INTRAVENOUS

8315665 FDA Received Date06-Jan-2012 Preferred Term

Case # 8315665

Case Type EXPEDITED (15-DAY) Product RITUXIMAB

Health Professional

Outcomes OT Role Route S S S S S

Manufacturer Control # FR-ROCHE-1024557 Dosage Text

Age

Sex Unknown

Country FRA

Duration

Manufacturer

CYTOKINE RELEASE SYNDROME CHILLS INFUSION RELATED REACTION

CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE PREDNISONE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 28 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8324994 FDA Received Date06-Jan-2012 Preferred Term LIP SWELLING URTICARIA Case # 8324994 Case Type DIRECT Product PREDNISONE Health Professional N Outcomes OT Role Route S ORAL Dosage Text 2 tablets Manufacturer Control # Age 54 YR Duration Sex Male Country USA Manufacturer

8325079 FDA Received Date06-Jan-2012

Case # 8325079

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes LT,OT

Manufacturer Control # US-PFIZER INC-2012003760 Dosage Text UNK UNK 350 mg, daily 60 mg, UNK 200 mg, daily 5 mg, daily 2.5 mg, weekly 20 mg, UNK 1 mg, daily 800 mg, daily 100 ug, UNK 10 mg, as needed

Age

Sex Female

Country USA

Preferred Term NEOPLASM MALIGNANT SPINAL CORD INJURY EXOSTOSIS BONE DENSITY DECREASED MUSCLE SPASMS DRUG INTOLERANCE

Product CHANTIX PREDNISONE CARISOPRODOL CYMBALTA PLAQUENIL LEUCOVORIN CALCIUM METHOTREXATE SIMVASTATIN FOLIC ACID GABAPENTIN LEVOTHYROXINE LEVOTHYROXINE METHADONE

Role Route S S S C C C C C C C C C C

Duration

Manufacturer PFIZER

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 29 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8325422 FDA Received Date06-Jan-2012 Preferred Term CEREBRAL ISCHAEMIA BRONCHOPULMONARY ASPERGILLOSIS ASPERGILLOSIS SUBCUTANEOUS NODULE PLEURAL EFFUSION PYREXIA ASTHENIA ERYTHEMA PAIN Case # 8325422 Case Type EXPEDITED (15-DAY) Product PREDNISONE TACROLIMUS TACROLIMUS SIROLIMUS INSULIN NOS AMPHOTERICIN B Health Professional Y Outcomes DE,OT Role Route S S S S C C INTRAVENOUS 5 mg/kg, UNK Manufacturer Control # PHHY2012PT000794 Dosage Text 7.5 mg/day 4 mg/day 1.5 mg/day 1 mg/day Age 67 YR Duration Sex Female Country PRT

Manufacturer

8325431 FDA Received Date06-Jan-2012

Case # 8325431

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # FRWATSON-2011-22619 Dosage Text 5 mg 100 mg daily

Age 71 YR

Sex Female

Country FRA

Preferred Term LEUKOENCEPHALOPATHY JC VIRUS INFECTION CEREBRAL ISCHAEMIA COMA DIARRHOEA EPISTAXIS FALL FEMUR FRACTURE NEUTROPENIA PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY RENAL FAILURE RHINITIS SCLERITIS VASCULITIS CEREBRAL

Product PREDNISONE AZATHIOPRINE

Role Route S S

Duration

Manufacturer WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 30 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8325596 FDA Received Date06-Jan-2012 Case # 8325596 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # USMYLANLABS-2011S1021 833 Role Route S S S Dosage Text Age 60 YR Sex Female Country USA

Preferred Term BLOOD CREATINE PHOSPHOKINASE INCREASED FATIGUE ASTHENIA GAIT DISTURBANCE

Product AZATHIOPRINE METHOTREXATE PREDNISONE

Duration

Manufacturer MYLAN BIONICHE

8325810 FDA Received Date06-Jan-2012

Case # 8325810

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes LT

Manufacturer Control # FR-GLAXOSMITHKLINEB0772183A

Age 19 YR

Sex Male

Country FRA

Preferred Term THROMBOTIC MICROANGIOPATHY

Product VALACYCLOVIR HYDROCHLORIDE PROGRAF NIPENT PREDNISONE BACTRIM LEUCOVORIN CALCIUM AMITRIPTYLINE HYDROCHLORIDE NEORAL CELLCEPT

Role Route S S S S S S S C C ORAL ORAL INTRAVENOUS ORAL ORAL ORAL ORAL

Dosage Text

Duration

Manufacturer GLAXOSMITHKLINE

2MG Twice per day

183 DAY 35 DAY 1.9 YEAR 1.9 YEAR 288 DAY GLAXOSMITHKLINE GLAXOSMITHKLINE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 31 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8325857 FDA Received Date06-Jan-2012 Case # 8325857 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # USABBOTT-11P-163-08882 85-00 Dosage Text Ingestion Ingestion Ingestion Ingestion Ingestion Ingestion Ingestion Ingestion Ingestion Manufacturer Control # US-ROXANE LABORATORIES, INC.-2011-RO-01789RO Role Route S ORAL Dosage Text Duration Age Sex Male Country USA Age 59 YR Sex Female Country USA

Preferred Term COMPLETED SUICIDE

Product HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARBAMAZEPINE ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE ALPRAZOLAM PREDNISONE OMEPRAZOLE

Role Route S S S S S S S S S Outcomes

Duration

Manufacturer

8326214 FDA Received Date07-Jan-2012

Case # 8326214

Case Type NON-EXPEDITED

Health Professional N

Preferred Term PAIN IN EXTREMITY MUSCULAR WEAKNESS

Product PREDNISONE

Manufacturer ROXANE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 32 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8326217 FDA Received Date07-Jan-2012 Case # 8326217 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-ROXANE LABORATORIES, INC.-2011-RO-01813RO Role Route S S C C C C C Health Professional Y Outcomes HO Role Route S S S S S S S C C C C C C C INTRAVENOUS ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL INTRAVENOUS INTRAVENOUS Manufacturer Control # PHHY2011US104572 Dosage Text 4 mg, every 4 weeks 25 mg, 25 mg, 150 mg 149 mg, 1 in 3 week 10 mg Daily 10 mg Daily 22.5 mg, Every 3 months 0.3 mg, 5 mg, 0-0-1 1 U, 1 tab 30 GTT 2U 1 DAY Age 74 YR Duration Sex Male Country USA Manufacturer ORAL ORAL Dosage Text 10 mg 5 mg 2 mg 6 mg 40 mg 10 mg Duration Age Sex Male Country USA

Preferred Term RIB FRACTURE

Product PREDNISONE PREDNISONE LOVAZA COUMADIN NEXIUM GLUCOTROL FOLIC ACID

Manufacturer ROXANE ROXANE

8326241 FDA Received Date08-Jan-2012 Preferred Term ABSCESS JAW PAIN IN JAW LYMPHADENOPATHY

Case # 8326241

Case Type EXPEDITED (15-DAY) Product ZOMETA

LENALIDOMIDE LENALIDOMIDE DOCETAXEL DOCETAXEL PREDNISONE PREDNISONE ELIGARD MOXONIDINE RAMIPRIL SELEN DICLOFENAC SODIUM NOVALGIN BLOOD AND RELATED PRODUCTS

CONNECTIVE TISSUE INFLAMMATION OSTEOSARCOMA METASTATIC

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 33 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8268094 FDA Received Date09-Jan-2012 Case # 8268094 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # DKJNJFOC-20111111101 Dosage Text Age 65 YR Sex Male Country DNK

Preferred Term DEEP VEIN THROMBOSIS LUNG INFECTION

Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE RITUXIMAB PREDNISONE CYCLOPHOSPHAMIDE VINCRISTINE SULFATE VINCRISTINE SULFATE NEUPOGEN VINBLASTINE SULFATE MORPHINE OXYCODONE HYDROCHLORIDE PANTOPRAZOLE METOPROLOL SUCCINATE

Role Route S S S S S S S S S S C C C C INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS SUBCUTANEOUS INTRAVENOUS UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Duration

Manufacturer

8326556 FDA Received Date09-Jan-2012

Case # 8326556

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # BE-AMGENBELSP2012000554 Dosage Text 6 mg, UNK 613 mg, UNK 500 mg, UNK 1245 mg, UNK 31 mg, UNK 1 mg, UNK

Age 32 YR

Sex Female

Country BEL

Preferred Term FEBRILE NEUTROPENIA

Product NEUPOGEN RITUXIMAB PREDNISONE CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE

Role Route S S S S S S SUBCUTANEOUS INTRAVENOUS ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS

Duration

Manufacturer AMGEN

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 34 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8327015 FDA Received Date09-Jan-2012 Case # 8327015 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE Manufacturer Control # USJNJFOC-20120101873 Dosage Text Age 58 YR Sex Female Country USA

Preferred Term COMPLETED SUICIDE TOXICITY TO VARIOUS AGENTS

Product OXYCODONE AND ACETAMINOPHEN PREDNISONE ALPRAZOLAM

Role Route S S S ORAL ORAL ORAL

Duration

Manufacturer

8327553 FDA Received Date09-Jan-2012

Case # 8327553

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # NZ-GLAXOSMITHKLINEB0699340A Dosage Text 8MG Unknown 100MG per day 140MG Unknown 2.5MG Per day 95MG Twice per day 2.5MG Per day 95MG per day Manufacturer Control # US-ENDO PHARMACEUTICALS INC.-PRED20120001

Age 81 YR

Sex Male

Country NZL

Preferred Term DIARRHOEA NEUTROPENIA

Product MELPHALAN THALIDOMIDE PREDNISONE WARFARIN SODIUM BENDROFLUAZIDE METOPROLOL TARTRATE BENDROFLUAZIDE METOPROLOL TARTRATE

Role Route S S S C C C C C UNKNOWN ORAL UNKNOWN ORAL ORAL ORAL ORAL ORAL

Duration 44 DAY 44 DAY

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE

8327651 FDA Received Date09-Jan-2012

Case # 8327651

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes

Age 74 YR

Sex Male

Country USA

Preferred Term DYSPNOEA ANAEMIA MUSCULAR WEAKNESS

Product PREDNISONE RAMUCIRUMAB MITOXANTRONE LUPRON ASPIRIN

Role Route S S S C C ORAL

Dosage Text UNKNOWN

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 35 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8327669 FDA Received Date09-Jan-2012 Case # 8327669 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # US-ENDO PHARMACEUTICALS INC.-PRED20110170 Dosage Text UNKNOWN Age 67 YR Sex Male Country USA

Preferred Term OSTEONECROSIS OF JAW

Product PREDNISONE MITOXANTRONE RAMUCIRUMAB ZOLEDRONIC ACID LEXAPRO PAXIL BENICAR LOPRESSOR

Role Route S S S S C C C C UNKNOWN UNKNOWN UNKNOWN UNKNOWN ORAL

Duration

Manufacturer

UNKNOWN UNKNOWN UNKNOWN UNKNOWN Manufacturer Control # IT-PFIZER INC-2012001196 Dosage Text 15 mg/m2, on day 1 1 mg/m2, on day 1 300 mg/m2, on day 1 40 mg/m2, for 5 days every 3 weeks for 6 cycles 375 mg/m2, on day 2 of each cycle Manufacturer Control # USWATSON-2011-22726 Dosage Text UNK UNK Age 72 YR Sex Female Country USA Age 12 YR Sex Male Country ITA

8327692 FDA Received Date09-Jan-2012

Case # 8327692

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Preferred Term NEOPLASM MALIGNANT HEPATOBLASTOMA

Product DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE CYCLOPHOSPHAMIDE PREDNISONE

Role Route S S S S

Duration

Manufacturer PFIZER

RITUXIMAB

S Health Professional Y Outcomes OT

8327936 FDA Received Date09-Jan-2012

Case # 8327936

Case Type EXPEDITED (15-DAY)

Preferred Term FEMUR FRACTURE IMPAIRED HEALING

Product ALENDRONATE SODIUM PREDNISONE

Role Route S S

Duration 10 YEAR 16 YEAR

Manufacturer WATSON WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 36 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8327939 FDA Received Date09-Jan-2012 Case # 8327939 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USWATSON-2011-22728 Dosage Text UNK UNK Manufacturer Control # USWATSON-2011-22727 Dosage Text UNK UNK Manufacturer Control # USWATSON-2011-22725 Dosage Text UNK UNK Age 38 YR Sex Female Country USA

Preferred Term FEMUR FRACTURE IMPAIRED HEALING

Product ALENDRONATE SODIUM PREDNISONE Case # 8327941 Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S S Outcomes OT

Duration 3 YEAR 20 YEAR Age 77 YR Sex

Manufacturer WATSON WATSON Country USA

8327941 FDA Received Date09-Jan-2012

Female

Preferred Term FEMUR FRACTURE IMPAIRED HEALING

Product ALENDRONATE SODIUM PREDNISONE Case # 8327942 Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S S Outcomes OT

Duration 9 YEAR 10 YEAR Age 76 YR Sex

Manufacturer WATSON WATSON Country USA

8327942 FDA Received Date09-Jan-2012

Female

Preferred Term FEMUR FRACTURE IMPAIRED HEALING

Product ALENDRONATE SODIUM PREDNISONE

Role Route S S

Duration 11 YEAR 14 YEAR

Manufacturer WATSON WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 37 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8340063 FDA Received Date09-Jan-2012 Preferred Term THROMBOTIC MICROANGIOPATHY Case # 8340063 Case Type EXPEDITED (15-DAY) Product PENTOSTATIN Health Professional Y Outcomes LT Role Route S INTRAVENOUS Manufacturer Control # 1150231 Dosage Text 3 MG/M 2 MILLIGRAM (S)/SQ. METER 4 MG/M 2 MILLIGRAM(S)/SQ. METER 2 MG MILLIGRAM(S), 1 DAY, ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # Age 80 YR Dosage Text 1080 MG 56 MG 288 MG 900 MG 540 MG 2.4 MG Duration Sex Female Country USA 183 DAY Age 19 YR Duration Sex Male Country FRA Manufacturer

CONVULSION FALL HEAD INJURY HAEMORRHAGE INTRACRANIAL

PROGRAF PREDNISONE VALACYCLOVIR HYDROCHLORIDE BACTRIM LEUCOVORIN CALCIUM AMITRIPTYLINE HYDROCHLORIDE

S S S S S S

ORAL ORAL ORAL ORAL ORAL ORAL

8343459 FDA Received Date09-Jan-2012 Preferred Term ASTHENIA NEUTROPENIA THROMBOCYTOPENIA

Case # 8343459

Case Type DIRECT Product

Health Professional

Outcomes HO Role Route S S S S S S

Manufacturer

CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE ETOPOSIDE PREDNISONE RITUXIMAB VINCRISTINE SULFATE

MUCOSAL INFLAMMATION CULTURE URINE POSITIVE ESCHERICHIA TEST POSITIVE HYPOKALAEMIA HYPOPHAGIA

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 38 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7818550 FDA Received Date10-Jan-2012 Preferred Term CUSHINGOID VIRAL INFECTION RENAL HYPERTROPHY CHOLELITHIASIS Case # 7818550 Case Type EXPEDITED (15-DAY) Product VOLTAREN HUMIRA METHOTREXATE PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN PREDNISONE PERINDOPRIL HYDROCORTISONE HYDROCORTISONE TRAMADOL HYDROCHLORIDE Health Professional Y Outcomes HO,OT Role Route S S S S SUBCUTANEOUS ORAL ORAL Manufacturer Control # PHHY2011FR10795 Dosage Text UNK 1 DF, BIW 15 mg, per week UNK Age 35 YR Duration Sex Female Country FRA

Manufacturer

AUTOIMMUNE HEPATITIS Hepatitis HEPATOMEGALY HEPATIC STEATOSIS CHRONIC HEPATITIS COUGH HEPATIC FIBROSIS INFLAMMATION

S C C C C

10 mg, UNK UNK 10 mg, per day 60 mg daily UNK 2 YEAR

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 39 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8055550 FDA Received Date10-Jan-2012 Preferred Term PULMONARY OEDEMA FAECALOMA ESCHERICHIA SEPSIS URINARY TRACT INFECTION POLYNEUROPATHY CONSTIPATION DIAPHRAGMATIC PARALYSIS PNEUMONIA Case # 8055550 Case Type EXPEDITED (15-DAY) Product VELCADE LENALIDOMIDE PREDNISONE METHYLPREDNISOLONE ASAFLOW GASTROGRAFIN ASPIRIN CORDARONE CALCIUM CARBONATE CYANOCOBALAMIN\PYRIDOXINE \THIAMINE OMEPRAZOLE SODIUM PICOSULFATE METILDIGOXIN LORAZEPAM BLOOD CELLS, PACKED HUMAN LASIX ACETYLCYSTEINE Health Professional Y Outcomes DE,HO,OT Role Route S S S S C C C C C C C C C C C C C Outcomes HO Manufacturer Control # DK-AMGENDNKSP2011054187 Dosage Text 6 mg, UNK 1800 mg, UNK 750 mg, UNK 120 mg, UNK 2 mg, UNK ORAL 100 mg, UNK 5 DAY 5 DAY Age 62 YR Sex Male Country DNK INTRAVENOUS ORAL UNKNOWN ORAL Manufacturer Control # BE-MPIJNJ-2010-02783 Dosage Text 1.8 mg/m2, Cyclic 5 mg, UNK 160 mg, UNK 64 mg, Cyclic 80 mg, UNK UNK 4 DAY Duration 45 DAY 45 DAY Age Sex Unknown Country BEL

Manufacturer MILLENNIUM

8198599 FDA Received Date10-Jan-2012

Case # 8198599

Case Type EXPEDITED (15-DAY)

Health Professional Y

Preferred Term SKIN INFECTION

Product NEUPOGEN CYCLOPHOSPHAMIDE RITUXIMAB DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE PREDNISONE

Role Route S S S S S S SUBCUTANEOUS

Duration

Manufacturer AMGEN

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 40 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8305454 FDA Received Date10-Jan-2012 Case # 8305454 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,LT Manufacturer Control # FR-CELGENEUS-056C5013-11122141 Dosage Text 75 5 10 Milligram 122 DAY Age 64 YR Sex Male Country FRA

Preferred Term DEHYDRATION DIARRHOEA FEBRILE NEUTROPENIA HYPOTENSION

Product LENALIDOMIDE DOCETAXEL DOCETAXEL PREDNISONE BISOPROLOL FUMARATE ALLOPURINOL DIGOXIN ACETAMINOPHEN TAMSULOSIN HYDROCHLORIDE SINTROM FUROSEMIDE ACTONEL HEPARIN

Role Route S S S S C C C C C C C C C Health Professional Y ORAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Duration 108 DAY

Manufacturer CELGENE

500 Milligram

8320086 FDA Received Date10-Jan-2012

Case # 8320086

Case Type EXPEDITED (15-DAY)

Outcomes OT

Manufacturer Control # USWATSON-2011-22580 Dosage Text 60 mg daily

Age 36 YR

Sex Male

Country USA

Preferred Term HYPERAMMONAEMIC ENCEPHALOPATHY

Product PREDNISONE

Role Route S ORAL

Duration

Manufacturer WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 41 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8328299 FDA Received Date10-Jan-2012 Case # 8328299 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # DEJNJFOC-20120101595 Dosage Text 2 cycle 1 cycle 3 cycle 1 cycle 2 cycle 1 cycle 2 cycle 1 cycle 2 cycle 2 cycle 1 cycle Age 23 YR Sex Unknown Country DEU

Preferred Term SYNCOPE DYSPNOEA

Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NEULASTA NEULASTA NEULASTA GEMCITABINE GEMCITABINE VINBLASTINE SULFATE VINBLASTINE SULFATE PREDNISONE PREDNISONE METOCLOPRAMIDE HYDROCHLORIDE GRANISETRON HYDROCHLORIDE

Role Route S S S S S S S S S S S C C INTRAVENOUS INTRAVENOUS SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL UNKNOWN UNKNOWN

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 42 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8328300 FDA Received Date10-Jan-2012 Case # 8328300 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # NLJNJFOC-20120101588 Dosage Text Age 35 YR Sex Male Country NLD

Preferred Term TONSILLITIS

Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NEUPOGEN NEUPOGEN RITUXIMAB RITUXIMAB PREDNISONE PREDNISONE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE VINBLASTINE SULFATE VINBLASTINE SULFATE

Role Route S S S S S S S S S S S S INTRAVENOUS INTRAVENOUS SUBCUTANEOUS SUBCUTANEOUS INTRAVENOUS ORAL ORAL ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS

Duration

Manufacturer

8328532 FDA Received Date10-Jan-2012

Case # 8328532

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # NL-AMGENNLDSP2012001050 Dosage Text 6 mg, UNK 700 mg, UNK 1400 mg, UNK 94 mg, UNK 2 mg, UNK 100 mg, UNK

Age 70 YR

Sex Female

Country NLD

Preferred Term PNEUMONIA

Product NEUPOGEN RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE PREDNISONE

Role Route S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL

Duration

Manufacturer AMGEN

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 43 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8329100 FDA Received Date10-Jan-2012 Case # 8329100 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # US-ARROW GEN-2011-23198 Dosage Text UNK UNK UNK Manufacturer Control # USWATSON-2011-23200 Dosage Text UNK UNK Manufacturer Control # FRASTRAZENECA-2012SE 01421 Dosage Text 160/4.5 UG PER DOSE, TWO INHALATIONS EACH MORNING AND ONE INHALATION EACH EVENING 5 YEAR 8 YEAR Age 75 YR Sex Female Age 51 YR Sex Female Country USA

Preferred Term STRESS FRACTURE IMPAIRED HEALING

Product ALORA ALENDRONATE SODIUM PREDNISONE

Role Route S S S Outcomes HO,OT

Duration

Manufacturer WATSON WATSON WATSON Country USA

8329267 FDA Received Date10-Jan-2012

Case # 8329267

Case Type EXPEDITED (15-DAY)

Health Professional Y

Preferred Term FEMUR FRACTURE IMPAIRED HEALING

Product ALENDRONATE SODIUM PREDNISONE Case # 8329645 Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S S Outcomes DE,OT ORAL

Duration 10 YEAR 11 YEAR Age 63 YR Sex

Manufacturer WATSON WATSON Country FRA

8329645 FDA Received Date10-Jan-2012

Female

Preferred Term CARDIAC ARREST

Product SYMBICORT

Role Route S INHALATION

Duration

Manufacturer ASTRAZENECA

RESPIRATORY DISORDER

PREDNISONE NASACORT VENTOLIN EBASTINE DESLORATADINE

S C C C C

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 44 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8335571 FDA Received Date10-Jan-2012 Preferred Term DIZZINESS Case # 8335571 Case Type DIRECT Product PREDNISONE Health Professional N Outcomes OT Role Route S ORAL Dosage Text 4 PILLS 1 TIME A DAY ORAL TOOK 7 DAYS WAS GO DOWN 1 PILL EVERY 7 DAYS Manufacturer Control # Age 51 YR Duration 7 DAY Sex Female Country USA

Manufacturer

CHILLS FLUSHING HEADACHE LOCAL SWELLING NERVOUSNESS PALPITATIONS PHARYNGEAL OEDEMA SWELLING FACE

8281633 FDA Received Date11-Jan-2012

Case # 8281633

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # DK-AMGENDNKSP2011064935 Dosage Text 6 mg, qd 750 mg, UNK 11500 mg, qd 100 mg, qd 2 mg, qd 100 mg, qd

Age 42 YR

Sex Male

Country DNK

Preferred Term UPPER RESPIRATORY TRACT INFECTION

Product NEUPOGEN RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE VINCRISTINE SULFATE PREDNISONE VALACYCLOVIR HYDROCHLORIDE SULFAMETHOXAZOLE AND TRIMETHOPRIM

Role Route S S S S S S C C SUBCUTANEOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL

Duration

Manufacturer AMGEN

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 45 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8295051 FDA Received Date11-Jan-2012 Case # 8295051 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # DK-PFIZER INC-2011301679 Dosage Text 100 mg, 1x/day 6 mg, 1x/day 750 mg, UNK 11500 mg, 1x/day 2 mg, 1x/day 100 mg, 1x/day Manufacturer Control # FRABBOTT-12P-056-08891 31-00 Dosage Text Age 26 YR Sex Female Country FRA Age 42 YR Sex Male Country DNK

Preferred Term UPPER RESPIRATORY TRACT INFECTION

Product DOXORUBICIN HYDROCHLORIDE NEUPOGEN RITUXIMAB CYCLOPHOSPHAMIDE VINCRISTINE SULFATE PREDNISONE

Role Route S S S S S S INTRAVENOUS SUBCUTANEOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL

Duration

Manufacturer PFIZER

8329759 FDA Received Date11-Jan-2012

Case # 8329759

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Preferred Term DRUG ERUPTION PSORIASIS PRURITUS

Product HUMIRA PREDNISONE

Role Route S S SUBCUTANEOUS ORAL

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 46 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8330098 FDA Received Date11-Jan-2012 Case # 8330098 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # FRWATSON-2011-22620 Dosage Text 1 dosage form, daily 5 mg, tid 10 mg, daily 1 mg, daily Age 93 YR Sex Female Country FRA

Preferred Term DIABETES MELLITUS

Product LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE PREDNISONE RABEPRAZOLE SODIUM LORAZEPAM TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN POTASSIUM CHLORIDE FLUINDIONE ASPIRIN

Role Route S S C C C C C C Health Professional Y Outcomes HO,DS,LT,OT ORAL ORAL UNKNOWN UNKNOWN

Duration

Manufacturer WATSON

75 mg, daily Manufacturer Control # US-ROXANE LABORATORIES, INC.-2012-RO-00454RO Dosage Text 60 mg 5 mg 800 mg 40 mg 80 mg Age 78 YR Sex Male Country USA

8330156 FDA Received Date11-Jan-2012

Case # 8330156

Case Type EXPEDITED (15-DAY)

Preferred Term GASTRIC HAEMORRHAGE HYPERKALAEMIA ATRIAL FIBRILLATION THROMBOSIS

Product PREDNISONE PREDNISONE SORAFENIB LOVENOX LOVENOX

Role Route S S S C C ORAL ORAL ORAL SUBCUTANEOUS SUBCUTANEOUS

Duration

Manufacturer ROXANE ROXANE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 47 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8330349 FDA Received Date11-Jan-2012 Case # 8330349 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # USWATSON-2012-00347 Dosage Text UNK Age 42 YR Sex Female Country USA

Preferred Term FOOT FRACTURE

Product ALENDRONATE SODIUM UNSPECIFIED INGREDIENT ESTRADIOL PREDNISONE CHOLECALCIFEROL

Role Route S S S S S Outcomes OT

Duration 3 YEAR

Manufacturer WATSON WATSON WATSON

8330350 FDA Received Date11-Jan-2012

Case # 8330350

Case Type EXPEDITED (15-DAY)

Health Professional Y

Manufacturer Control # USWATSON-2012-00343 Dosage Text UNK

Age 35 YR

Sex Female

Country USA

Preferred Term FOOT FRACTURE RIB FRACTURE

Product ALENDRONATE SODIUM UNSPECIFIED INGREDIENT CHOLECALCIFEROL PREDNISONE ESTROGEN NOS

Role Route S S S S S

Duration 4 YEAR

Manufacturer WATSON

WATSON

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 48 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8330587 FDA Received Date11-Jan-2012 Preferred Term COMPLETED SUICIDE Case # 8330587 Case Type EXPEDITED (15-DAY) Product HYDROCODONE BITARTRATE AND ACETAMINOPHEN ALPRAZOLAM OMEPRAZOLE CARBAMAZEPINE ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE PREDNISONE Health Professional Y Outcomes DE Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # FR-ROCHE-1028792 Dosage Text Age 85 YR Duration Sex Female Country FRA Manufacturer Control # US-UCBSA-048940 Dosage Text Age 59 YR Duration Sex Female Country USA

Manufacturer

8331244 FDA Received Date11-Jan-2012 Preferred Term

Case # 8331244

Case Type EXPEDITED (15-DAY) Product CELLCEPT

Health Professional Y

Outcomes HO Role Route S S S S S C C C ORAL ORAL

Manufacturer

RECTAL HAEMORRHAGE MELAENA ANAEMIA

PREDNISONE CITALOPRAM NEXIUM NEXIUM CALCIUM CARBONATE CALCIUM CARBONATE DIGOXIN

half dose form daily

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 49 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8331520 FDA Received Date11-Jan-2012 Preferred Term WOUND DEHISCENCE INCISION SITE HAEMORRHAGE Case # 8331520 Case Type EXPEDITED (15-DAY) Product PREDNISONE MYCOPHENOLATE MOFETIL PROGRAF INSULIN NOS LANTUS Health Professional Y Outcomes HO,OT Role Route S S C C C Health Professional Outcomes DE,HO,OT Role Route S S S S S S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL ORAL Given on Days 2-14 60mg x 6 days and 30mg x 7 days (Given on days 2 to 14) UNK tablet, Days 2-14 100 mg, Days 1&15 Manufacturer Control # US-ROCHE-GNE245520 Dosage Text Given on Days 1 & 15 Given on Days 1 & 15 Given on Days 1 & 15 Given on Days 1 & 15 Given on Days 1 & 15 Given on Days 1 & 15 Given on days 1 & 15 100 mg, Days 1&15 Age 50 YR Duration 16 DAY 16 DAY 16 DAY 16 DAY 16 DAY 10 DAY 10 DAY 10 DAY Sex Female Country USA ORAL 1000 mg, BID Manufacturer Control # PHHO2010US13126 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

8331534 FDA Received Date11-Jan-2012 Preferred Term

Case # 8331534

Case Type EXPEDITED (15-DAY) Product RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB RITUXIMAB

Manufacturer

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY OROPHARYNGEAL CANCER STAGE UNSPECIFIED STAPHYLOCOCCAL INFECTION PYREXIA DYSPHAGIA CATHETER SITE INFECTION PHARYNGEAL INFLAMMATION VENOUS THROMBOSIS LIMB PNEUMONIA BACTERIAL ACUTE SINUSITIS BACTERAEMIA

METHYLPREDNISOLONE METHYLPREDNISOLONE METHYLPREDNISOLONE PREDNISONE PREDNISONE PREDNISONE

PREDNISONE PREDNISONE PREDNISONE CARBOPLATIN CETUXIMAB ARMODAFINIL

S S S S S C

ORAL ORAL

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 50 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8331534Preferred Term Product ACYCLOVIR ACYCLOVIR VIGAMOX VIGAMOX DOXYCYCLINE DOXYCYCLINE CHOLECALCIFEROL ESTRATEST SYNTHROID METHOTREXATE METHOTREXATE FOLIC ACID FOLIC ACID DARVOCET CLINDAMYCIN HYDROCHLORIDE INVANZ LOTRISONE LOVENOX RANITIDINE PROVIGIL CYMBALTA ESTROGEN NOS LEVOTHYROXINE SODIUM FLUCONAZOLE LODINE RADIATION THERAPY LEVAQUIN ACETAMINOPHEN DECADRON REGLAN NEXIUM Role Route C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C 5 YEAR 5 YEAR ORAL ORAL 400 mg, UNK Dosage Text Duration Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 51 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8331534Preferred Term Product OXYCONTIN Role Route C Health Professional Outcomes HO Product CYCLOPHOSPHAMIDE DOXORUBICIN HYDROCHLORIDE ETOPOSIDE PREDNISONE RITUXIMAB VINCRISTINE SULFATE Role Route S S S S S S Dosage Text 2462 MG 32.8 MG 164 MG 1360 MG 855 MG .912 MG Manufacturer Control # Age 61 YR Duration Sex Male Country USA Manufacturer Dosage Text Duration Manufacturer

8338418 FDA Received Date11-Jan-2012 Preferred Term COUGH

Case # 8338418

Case Type DIRECT

OROPHARYNGEAL PAIN ANAEMIA PNEUMONIA LUNG INFILTRATION WHITE BLOOD CELL COUNT INCREASED PLATELET COUNT DECREASED

8353241 FDA Received Date11-Jan-2012 Preferred Term POISONING COMPLETED SUICIDE

Case # 8353241

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes DE Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Manufacturer Control # VAL_00677_2012 Dosage Text (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL)

Age 59 YR Duration

Sex Female

Country USA

Manufacturer

CARBAMAZEPINE HYDROCODONE BITARTRATE AND ACETAMINOPHEN ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE ALPRAZOLAM PREDNISONE OMEPRAZOLE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 52 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8355230 FDA Received Date11-Jan-2012 Preferred Term POISONING COMPLETED SUICIDE Case # 8355230 Case Type EXPEDITED (15-DAY) Product ATENOLOL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARBAMAZEPINE ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE ALPRAZOLAM PREDNISONE OMEPRAZOLE Health Professional Y Outcomes DE Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # NSR_00360_2012 Dosage Text (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) (DF ORAL) Manufacturer Control # RU-SANOFIAVENTIS-2011SA03686 2 Dosage Text Age 73 YR Sex Male Country RUS Age 59 YR Duration Sex Female Country USA

Manufacturer

7990304 FDA Received Date12-Jan-2012

Case # 7990304

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes DE

Preferred Term PNEUMONIA

Product DOCETAXEL DOCETAXEL UNSPECIFIED INGREDIENT UNSPECIFIED INGREDIENT PREDNISONE PREDNISONE ASPIRIN

Role Route S S S S S S C INTRAVENOUS DRIP INTRAVENOUS DRIP ORAL ORAL UNKNOWN UNKNOWN ORAL

Duration 44 DAY 44 DAY 57 DAY 57 DAY 57 DAY 57 DAY

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 53 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8236400 FDA Received Date12-Jan-2012 Case # 8236400 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE,OT Manufacturer Control # US-PFIZER INC-2011261687 Dosage Text 37.5 mg, daily 2 weeks on/ 1 week off 1000 mg, 1x/day 5 mg, 2x/day 650 mg, every 4 hours, as needed 10 mg, daily 40 mg, daily 2.5 ml, every 6 hours 1.25 mg, every 6 hours 750 mg, daily 8 mg, every 8 hours, as needed 5 mg, every 4 hours, as needed 3.375 g, every 6 hours ORAL ORAL 2 tablets, 2x/day, as needed 0.4 mg, daily Manufacturer Control # USABBOTT-11P-163-08820 34-00 Dosage Text Age 44 YR Sex Male Country USA 94 DAY 94 DAY Age 75 YR Sex Male Country USA

Preferred Term PNEUMONIA

Product SUNITINIB MALATE ABIRATERONE ACETATE PREDNISONE ACETAMINOPHEN ATORVASTATIN LOVENOX IPRATROPIUM BROMIDE LEVOSALBUTAMOL LEVOFLOXACIN ZOFRAN ZOFRAN OXYCODONE ZOSYN SENOKOT TAMSULOSIN HYDROCHLORIDE

Role Route S S S C C C C C C C C C C C C ORAL ORAL ORAL ORAL ORAL ORAL SUBCUTANEOUS INHALATION INHALATION INTRAVENOUS INTRAVENOUS

Duration

Manufacturer PFIZER

8284069 FDA Received Date12-Jan-2012

Case # 8284069

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes DE

Preferred Term SEPTIC SHOCK PNEUMONIA BACTERIAL

Product HUMIRA METHOTREXATE PREDNISONE

Role Route S S S SUBCUTANEOUS

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 54 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8284961 FDA Received Date12-Jan-2012 Case # 8284961 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # FR-BRISTOL-MYERS SQUIBB COMPANY-16272734 Dosage Text Route:02 Age 71 YR Sex Male Country FRA

Preferred Term PNEUMONIA RESPIRATORY DISTRESS MULTI-ORGAN FAILURE

Product BELATACEPT CELLCEPT PREDNISONE PLAVIX IRBESARTAN

Role Route S S S C C

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 55 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8331457 FDA Received Date12-Jan-2012 Case # 8331457 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # FRABBOTT-12P-056-08900 97-00 Dosage Text Age 80 YR Sex Male Country FRA

Preferred Term FEMUR FRACTURE FALL DRUG INEFFECTIVE BONE DENSITY INCREASED

Product HUMIRA HUMIRA BONIVA PREDNISONE PREDNISONE ACTONEL ACTONEL PANTOPRAZOLE SODIUM NEXIUM SOTALOL HYDROCHLORIDE METHOTREXATE METHOTREXATE ARAVA

Role Route S S S S S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Duration

Manufacturer

From 24-Jun to sep not stated and 20mg/d since Sep-2008.

ACTEMRA DOXAZOSIN MESYLATE ACECLOFENAC ACETAMINOPHEN PANTOPRAZOLE TRAMADOL HYDROCHLORIDE CALCIUM CARBONATE

S S S S S S C ORAL ORAL ORAL ORAL ORAL

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 56 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8333927 FDA Received Date12-Jan-2012 Case # 8333927 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE,OT Manufacturer Control # IT-GENZYMECAMP-1002067 Dosage Text UNK UNK UNK UNK UNK UNK UNK UNK Manufacturer Control # IT-GENZYMECAMP-1002068 Dosage Text UNK 30 mg, once weekly for 18 weeks 12 10 mg every two weeks UNK UNK UNK UNK Duration Age Sex Unknown Country ITA Duration Age Sex Unknown Country ITA

Preferred Term SEPSIS GUILLAIN-BARRE SYNDROME

Product FLUDARA CAMPATH CHLORAMBUCIL CYCLOPHOSPHAMIDE ADRIAMYCIN VINCRISTINE SULFATE PREDNISONE RITUXIMAB

Role Route S S S S S S S S Health Professional Y UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Manufacturer GENZYME GENZYME

8334219 FDA Received Date12-Jan-2012

Case # 8334219

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term GUILLAIN-BARRE SYNDROME

Product FLUDARA CAMPATH CAMPATH CHLORAMBUCIL CYCLOPHOSPHAMIDE PREDNISONE VINCRISTINE SULFATE

Role Route S S S S S S S UNKNOWN SUBCUTANEOUS SUBCUTANEOUS UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Manufacturer GENZYME GENZYME GENZYME

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 57 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8334232 FDA Received Date12-Jan-2012 Preferred Term COMPLETED SUICIDE Case # 8334232 Case Type EXPEDITED (15-DAY) Product ALPRAZOLAM OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN PREDNISONE Health Professional Y Outcomes DE Role Route S S S ORAL ORAL ORAL Manufacturer Control # PHHY2012CA001339 Dosage Text 50 mg, QD Age 25 YR Duration Sex Male Country CAN Manufacturer Manufacturer Control # US-UCBSA-049087 Dosage Text Age 58 YR Duration Sex Female Country USA

Manufacturer

8334934 FDA Received Date12-Jan-2012 Preferred Term LIPOMA

Case # 8334934

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes OT Role Route S

PREDNISONE

MUSCULAR WEAKNESS PAIN IN EXTREMITY

8334936 FDA Received Date12-Jan-2012 Preferred Term JUVENILE ARTHRITIS

Case # 8334936

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes HO Role Route S S S S S S S S C C SUBCUTANEOUS ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL

Manufacturer Control # PHHO2011US07905 Dosage Text 1 mg, QD 5 mg, QD 4 mg, QD 3 mg, QD 2 mg, QD 1 mg, QD 10 mg, QD 41 mg/kg, UNK 20 mg, QD 25 mg, TID

Age 9 YR Duration 50 DAY 7 DAY 7 DAY 7 DAY 7 DAY

Sex Male

Country USA Manufacturer

PREDNISONE PREDNISONE PREDNISONE PREDNISONE PREDNISONE PREDNISONE PREDNISONE ILARIS METHOTREXATE INDOCIN

1.2 YEAR

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 58 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8335048 FDA Received Date12-Jan-2012 Preferred Term BLADDER TRANSITIONAL CELL CARCINOMA BLADDER SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED BLADDER ADENOCARCINOMA STAGE UNSPECIFIED RENAL CELL CARCINOMA MALIGNANT NEOPLASM OF RENAL PELVIS RENAL CANCER URETERIC CANCER Case # 8335048 Case Type EXPEDITED (15-DAY) Product CELLCEPT PREDNISONE AZATHIOPRINE CYCLOSPORINE Health Professional Y Outcomes DE Role Route S S S S Manufacturer Control # CN-ROCHE-1028712 Dosage Text Duration Age Sex Unknown Country CHN

Manufacturer

8353514 FDA Received Date12-Jan-2012 Preferred Term POISONING CARDIAC ARREST

Case # 8353514

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes DE Role Route S S S ORAL ORAL ORAL

Manufacturer Control # IMP_05656_2012 Dosage Text DF ORAL DF ORAL DF ORAL

Age 58 YR Duration

Sex Female

Country USA

Manufacturer

ALPRAZOLAM OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN PREDNISONE

RESPIRATORY ARREST COMPLETED SUICIDE

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 59 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8353555 FDA Received Date12-Jan-2012 Preferred Term POISONING COMPLETED SUICIDE Case # 8353555 Case Type EXPEDITED (15-DAY) Product ALPRAZOLAM HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARBAMAZEPINE ATENOLOL ENALAPRIL MALEATE HYDROXYCHLOROQUINE SULFATE BUSPIRONE HYDROCHLORIDE PREDNISONE OMEPRAZOLE Health Professional Y Outcomes DE Role Route S S S S S S S S S ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Manufacturer Control # IMP_05658_2012 Dosage Text DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL DF ORAL Manufacturer Control # DSA_48609_2011 Dosage Text 5 MG, QD, ORAL 7.5 MG QD, EVERY 24 HOURS ORAL 500 MG, TID, EVEREY 8 HOURS, ORAL Age 30 YR Duration Sex Female Country MEX Age 59 YR Duration Sex Female Country USA

Manufacturer

8354273 FDA Received Date12-Jan-2012 Preferred Term PREGNANCY

Case # 8354273

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes OT Role Route S S S C ORAL ORAL ORAL

Manufacturer

ENALAPRIL MALEATE PREDNISONE METHYLDOPA CYCLOPHOSPHAMIDE

MATERNAL EXPOSURE DURING PREGNANCY CAESAREAN SECTION PREMATURE DELIVERY AORTIC DISORDER RENOVASCULAR HYPERTENSION

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 60 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8242387 FDA Received Date13-Jan-2012 Case # 8242387 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # USJNJFOC-20090506533 Dosage Text Age 39 YR Sex Male Country USA

Preferred Term TENDON RUPTURE TENDONITIS POST-TRAUMATIC STRESS DISORDER

Product LEVAQUIN LEVAQUIN LEVAQUIN PREDNISONE

Role Route S S S S UNKNOWN UNKNOWN UNKNOWN UNKNOWN

Duration

Manufacturer

8258381 FDA Received Date13-Jan-2012

Case # 8258381

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # DK-PFIZER INC-2011286256 Dosage Text 85 mg, UNK 85 mg, UNK 85 mg, UNK 6 mg, UNK 6 mg, UNK 6 mg, UNK 650 mg, UNK 650 mg, UNK 650 mg, UNK 100 mg, UNK 100 mg, UNK 100 mg, UNK 1275 mg, UNK 1275 mg, UNK 1275 mg, UNK 2 mg, UNK 2 mg, UNK 2 mg, UNK

Age 61 YR

Sex Male

Country DNK

Preferred Term WEIGHT DECREASED FEBRILE NEUTROPENIA STOMATITIS DIARRHOEA

Product DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE NEUPOGEN NEUPOGEN NEUPOGEN RITUXIMAB RITUXIMAB RITUXIMAB PREDNISONE PREDNISONE PREDNISONE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE SULFATE

Role Route S S S S S S S S S S S S S S S S S S INTRAVENOUS INTRAVENOUS INTRAVENOUS SUBCUTANEOUS SUBCUTANEOUS SUBCUTANEOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS ORAL ORAL ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS

Duration

Manufacturer PFIZER PFIZER

1 DAY

PFIZER

1 DAY

5 DAY

1 DAY

1 DAY

8270598Date - Time: 02-05-2013 11:11:44 AM EST Note: If the field is blank, there is no data Page: 61 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8270598FDA Received Date 13-Jan-2012 Preferred Term HAEMATEMESIS CARDIOVASCULAR INSUFFICIENCY Case # 8270598 Case Type EXPEDITED (15-DAY) Product TORSEMIDE MARCUMAR Health Professional Y Outcomes DE Role Route S S ORAL ORAL Manufacturer Control # 2011110060 Dosage Text 100-150 MG/D, ORAL 1 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 AS REQUIRED) (1 IN 1 AS REQUIRED), ORAL WITH INCREASING DOSE 0.125 MG DAILY (0.125 MG, 1 IN 1 D), ORAL, 0.25 MG (0.25 MG, 1 IN 1 D), ORAL, 0 10 MG (10 MG, 1 IN 1 D), ORAL, 7.5 MG (7.5 MG, 1 IN 1 D), ORAL WITH INCREASING DOSE TO 35 MG DAILY (25 MG, 1 IN 1 D), ORAL, 35 MG (35 MG, 1 IN 1 D), ORAL 10 MG (5 MG, IN THE EVENING), ORAL 1 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 D), ORAL 2 DOSAGE FORMS (1 DOSAGE FORMS, 2 IN 1 D), ORAL 0.5 MG (0.5 MG, 1 IN 1 AS REQUIRED), ORAL 5 MG (5 MG, 1 IN 1 AS REQUIRED), INTRAVENOUS (NOT OTHERWISE SPECIFIED) Age 86 YR Duration Sex Female Country CHE

Manufacturer

HAEMOGLOBIN DECREASED

DIGOXIN

S

ORAL

RECTAL HAEMORRHAGE

PREDNISONE

S

ORAL

GASTRITIS

SEROQUEL

S

ORAL

MULTI-ORGAN DISORDER CHOLESTASIS

QUETIAPINE FUMARATE POTASSIUM BICARBONATE \POTASSIUM CITRATE POTASSIUM CHLORIDE

S S

ORAL ORAL

HYPERBILIRUBINAEMIA

S

ORAL

HYPOALBUMINAEMIA THROMBOCYTOPENIA

KONAKION KONAKION

S S

ORAL INTRAVENOUS

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 62 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8270598Preferred Term GASTROINTESTINAL HAEMORRHAGE Product JANUVIA CONCOR (BISOPROLOL FUARATE) HALDOL ACETAMINOPHEN NOVALGIN (METAMIZOLE SODIUM) PARAGOL (PHENOLPHTHALEIN, PARRAFIN, LIQUID) PROCTOGLYVENOL (LIDOCAINE HYDROCHLORIDE, TRIBENOSIDE) FUROSEMIDE RAMIPRIL Role Route C C C C C C C Dosage Text Duration Manufacturer

C C

8335410 FDA Received Date13-Jan-2012

Case # 8335410

Case Type NON-EXPEDITED

Health Professional N

Outcomes HO,OT

Manufacturer Control # USJNJFOC-20101200658 Dosage Text

Age

Sex Female

Country USA

Preferred Term ROTATOR CUFF SYNDROME TRIGGER FINGER

Product LEVAQUIN LEVAQUIN PREDNISONE

Role Route S S S ORAL ORAL UNKNOWN

Duration

Manufacturer

Date - Time: 02-05-2013 11:11:44 AM EST

Note: If the field is blank, there is no data

Page: 63 of 2,627

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8336320 FDA Received Date13-Jan-2012 Case # 8336320 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # FR-BRISTOL-MYERS SQUIBB COMPANY-16328973 Dosage Text from D1 to D3,Course 1,Course 2 on 12Dec11