Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10141770serious1Date Last Updated11/09/2014receiptdateformat102companynumbFR-PFIZER INC-2014112387occurcountryFRduplicate1Date Received29/04/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

Onset Age58Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionDisorientationOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionHaemorrhageOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionBrain contusionOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionLoss of consciousnessOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionDrug interactionOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionAnaemiaOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.1ReactionAlcohol poisoningOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionWound haemorrhageOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.1ReactionFallOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionAscitesOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductBIPRETERAXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAY

activesubstance

activesubstancenameINDAPAMIDE\PERINDOPRIL

2)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAYdrugadministrationroute048actiondrug3drugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

3)

drugcharacterization2medicinalproductSTILNOXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAY (AT BEDTIME)drugdosageformTABLET

activesubstance

activesubstancenameZOLPIDEM TARTRATE

4)

drugcharacterization3medicinalproductKARDEGICdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAYdrugdosageformPOWDER FOR ORAL SOLUTIONdrugadministrationroute048drugindicationCEREBROVASCULAR ACCIDENTdrugstartdateformat602drugstartdate//2011drugenddateformat102drugenddate13/03/2014actiondrug1

activesubstance

activesubstancenameASPIRIN LYSINE

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourcePFIZERduplicatenumbFR-PFIZER INC-2014112387

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use