Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10032909serious1Date Last Updated21/04/2014receiptdateformat102seriousnessdeath1companynumbUS-PFIZER INC-2014083492occurcountryUSseriousnessother1duplicate1Date Received24/03/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionHepatic failureOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKdrugenddateformat602drugenddate//2013actiondrug1

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

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014083492

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use