Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10079825serious1Date Last Updated15/04/2014receiptdateformat102companynumbUS-UCBSA-117749occurcountryUSduplicate1Date Received15/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSerotonin syndromeOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductKEPPRAdrugauthorizationnumb021035drugdosagetextDOSE UNKNOWNactiondrug5

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

2)

drugcharacterization1medicinalproductZOLOFTdrugdosagetextDOSE UNKNOWNactiondrug5

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)

drugcharacterization1medicinalproductNUEDEXTAdrugdosagetextDOS UNKNOWNactiondrug5

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)

drugcharacterization1medicinalproductZOFRANdrugdosagetextDOSE UNKNOWNactiondrug5

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

5)

drugcharacterization1medicinalproductFENTANYLdrugdosagetextDOSE UNKNOWNactiondrug5

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]

Report Duplicate

duplicatesourceUCBduplicatenumbUS-UCBSA-117749

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use