Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-PFIZER INC-2014085684occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10042023Date Received27/03/2014transmissiondate02/10/2014serious2Date Last Updated27/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age65Unit of Onset AgeyearsWeight98SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionHyperhidrosisOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, 1X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationDEPRESSIONactiondrug1

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

2)

drugcharacterization2medicinalproductINSULINdrugdosagetextUNKdrugindicationDIABETES MELLITUS

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014085684