Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10044554serious1Date Last Updated28/03/2014seriousnesslifethreatening1receiptdateformat102seriousnessdeath1companynumbFR-PFIZER INC-2014087459occurcountryFRduplicate1Date Received28/03/2014transmissiondate02/10/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

Onset Age76Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionHyperthyroidismOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionCardiac failureOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionCoronary artery stenosisOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCORDARONEdrugauthorizationnumb018972drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat610drugstartdate/12/2013drugenddateformat102drugenddate09/01/2014actiondrug1

2)

drugcharacterization2medicinalproductBISOCEdrugdosagetextUNK

3)

drugcharacterization2medicinalproductCIFLOXdrugdosagetextUNK

4)

drugcharacterization2medicinalproductKARDEGICdrugdosagetextUNK

5)

drugcharacterization2medicinalproductTAHORdrugdosagetextUNK

6)

drugcharacterization2medicinalproductLASILIXdrugdosagetextUNK

7)

drugcharacterization2medicinalproductALDACTONEdrugdosagetextUNK

openFDA Info on Medication

Application NumberNDA012151Brand NameALDACTONEGeneric NameSPIRONOLACTONEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1001, 0025-1041, 0025-1031Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 200817, 200820, 200825, 313096spl_idba392fd1-82d0-4a79-a555-72ab9837d283spl_set_id0fed2822-3a03-4b64-9857-c682fcd462bcPackage NDC0025-1001-31, 0025-1041-31, 0025-1031-31NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

8)

drugcharacterization2medicinalproductDOLIPRANEdrugdosagetextUNK

9)

drugcharacterization2medicinalproductACUPANdrugdosagetextUNK

10)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNK

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

11)

drugcharacterization2medicinalproductSERESTAdrugdosagetextUNK

Report Duplicate

duplicatesourcePFIZERduplicatenumbFR-PFIZER INC-2014087459

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use