Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10195639serious1Date Last Updated05/06/2014receiptdateformat102companynumbUS-009507513-1405USA010266occurcountryUSseriousnessother1duplicate1Date Received27/05/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age76Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRenal failureOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionInsomniaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionTinnitusOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductZETIAdrugauthorizationnumb021445drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERCHOLESTEROLAEMIAdrugstartdateformat602drugstartdate//2012drugenddateformat102drugenddate12/05/2014actiondrug1

openFDA Info on Medication

Application NumberNDA021445Brand NameZETIAGeneric NameEZETIMIBEManufacturersMerck Sharp & Dohme Corp.product_ndc66582-414Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBERXCUI349556, 352304spl_id2215c0c2-5f8d-4025-92b4-20b80d64194bspl_set_ida773b0b2-d31c-4ff4-b9e8-1eb2d3a4d62aPackage NDC 66582-414-31, 66582-414-54, 66582-414-74, 66582-414-76, 66582-414-29, 66582-414- ... NUIN0000008553, N0000175911Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]Established Pharmacologic ClassDietary Cholesterol Absorption Inhibitor [EPC]UNIIEOR26LQQ24

2)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKactiondrug5

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)

drugcharacterization2medicinalproductPLAVIXdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_idcb770afe-b6de-469f-9d9c-3db134394d4d, 12eb3088-f30b-4bb5-aee0-113114b5a08cspl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1405USA010266

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use