Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10058191serious1Date Last Updated04/04/2014receiptdateformat102companynumbUS-PFIZER INC-2014095308occurcountryUSseriousnessother1duplicate1Date Received04/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age63Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSerotonin syndromeOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKactiondrug5

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)

drugcharacterization1medicinalproductFENTANYLdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA022569, ANDA202097, ANDA077449, NDA021947, NDA202788, NDA019813, ANDA076258Brand NameLAZANDA, FENTANYL SYSTEM, FENTANYL, FENTORA, SUBSYS, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, Alvogen, Apotex Corp., Cephalon, Inc., Insys T ... product_ndc 71500-110, 71500-140, 71500-130, 47781-423, 47781-424, 47781-426, 47781-427, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, TRANSDERMAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 197696, 245134, 245135, 24 ... spl_id 9f5c9d6b-1f8a-0f2e-e053-2a95a90a1458, b9f82be8-5426-7518-e053-2995a90abd81, 4696 ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, 242759ef-cb6d-4e3e-9f8d-5e31efa1f289, 0ff7 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 47781-423-47, 47781-424-47, 47781-426- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

3)

drugcharacterization1medicinalproductNUEDEXTAdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA021879Brand NameNUEDEXTAGeneric NameDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEManufacturersAvanir Pharmaceuticals, Inc.product_ndc64597-301Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATERXCUI1040054, 1040058spl_id6ad080f6-a98f-424d-9c2c-5f9867e6fa9aspl_set_id484e0918-3442-49dc-8ccf-177f1f3ee9f3Package NDC64597-301-13, 64597-301-60UNII9D2RTI9KYH, J13S2394HE

4)

drugcharacterization1medicinalproductKEPPRAdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA021872, NDA021505, NDA021035, NDA022285Brand NameKEPPRA, KEPPRA XRGeneric NameLEVETIRACETAMManufacturersUCB, Inc.product_ndc 50474-002, 50474-001, 50474-594, 50474-595, 50474-596, 50474-597, 50474-598, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsLEVETIRACETAMRXCUI 647121, 647123, 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, ... spl_id 4a48c061-40c9-41d9-be30-e9521c3e03b5, f5f32bff-c998-43b5-920c-02f3fea3b46b, d6d8 ... spl_set_id c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e, 3ca9df05-a506-4ec8-a4fe-320f1219ab21, 2919 ... Package NDC 50474-002-63, 50474-594-40, 50474-595-40, 50474-596-40, 50474-597-66, 50474-001- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

5)

drugcharacterization1medicinalproductZOFRANdrugdosagetextUNKactiondrug5

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014095308

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use