Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10067486serious1Date Last Updated09/04/2014receiptdateformat102companynumbCA-JNJFOC-20140319257occurcountryCAduplicate1Date Received09/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryCA

Primary Source

reportercountryCAqualification3

Patient

Onset Age16Unit of Onset AgeyearsWeight57SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDepressionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductREMICADEdrugauthorizationnumb103772drugstructuredosagenumb300drugstructuredosageunit003drugdosageformLyophilized Powderdrugadministrationroute042drugindicationCROHN^S DISEASEdrugstartdateformat602drugstartdate//2008actiondrug4drugrecurreadministration2

openFDA Info on Medication

Application NumberBLA103772Brand NameREMICADEGeneric NameINFLIXIMABManufacturersJanssen Biotech, Inc.product_ndc57894-030Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsINFLIXIMABRXCUI213361, 310994spl_idba599d34-1a9a-47db-8414-8e7cfcb5d49dspl_set_ida0a046c1-056d-45a9-bfd9-13b47c24f257Package NDC57894-030-01NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNIIB72HH48FLU

2)

drugcharacterization2medicinalproductMACROBID (NITROFURANTOIN)drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute048drugstartdateformat102drugstartdate05/03/2014drugenddateformat102drugenddate12/03/2014

3)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUnspecifieddrugadministrationroute048drugstartdateformat102drugstartdate01/03/2014

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductBIRTH CONTROL PILLdrugdosageformUnspecifieddrugadministrationroute065

Report Duplicate

duplicatesourceJANSSENduplicatenumbCA-JNJFOC-20140319257

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use