Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10051860serious1Date Last Updated26/02/2016receiptdateformat102authoritynumbSE-MPA-2014-002136companynumbSE-PFIZER INC-2014087964occurcountrySEseriousnessother1duplicate1Date Received02/04/2014seriousnesshospitalization1transmissiondate25/05/2016primarysourcecountrySE

Primary Source

reportercountrySEqualification1

Patient

Onset Age29Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt19.0ReactionElectrocardiogram ST segment elevationOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionToxicity to various agentsOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.0ReactionTroponin T increasedOutcomeUnknown

4)

reactionmeddraversionpt19.0ReactionPericarditisOutcomeUnknown

5)

reactionmeddraversionpt19.0ReactionChest painOutcomeRecovered/resolved

6)

reactionmeddraversionpt19.0ReactionPyrexiaOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.0ReactionOverdoseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductVIAGRAdrugauthorizationnumb020895drugdosagetextHIGHdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate02/02/2013drugenddateformat102drugenddate02/02/2013

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA020895Brand NameVIAGRAGeneric NameSILDENAFIL CITRATEManufacturersU.S. Pharmaceuticals, Pfizer Laboratories Div Pfizer Incproduct_ndc63539-421, 63539-422, 0069-4200, 0069-4210, 0069-4220Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSILDENAFIL CITRATERXCUI213270, 213271, 312950, 314229, 213269, 314228spl_id44077f94-92ff-4cd3-ae7d-3913bd41d97a, 825327ae-a572-4b15-b9dd-1221249a7ac8spl_set_id442a09ee-e7de-4d53-a32e-07c7530cdede, 0b0be196-0c62-461c-94f4-9a35339b4501Package NDC 63539-421-97, 63539-422-02, 63539-422-03, 0069-4200-30, 0069-4210-30, 0069-4210- ... UNIIBW9B0ZE037

2)

drugcharacterization2medicinalproductOMEPRAZOLdrugdosagetextUNK

activesubstance

activesubstancenameOMEPRAZOLE

3)

drugcharacterization2medicinalproductINOLAXOLdrugdosagetextUNK

4)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNK

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20130202

Report Duplicate

duplicatesourcePFIZERduplicatenumbSE-PFIZER INC-2014087964

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use