Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10061311serious1Date Last Updated07/04/2014receiptdateformat102companynumbGB-RANBAXY-2014RR-79613occurcountryGBduplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Onset Age75Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductASPIRINdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

2)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077977drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductAMLODIPINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

4)

drugcharacterization2medicinalproductCITALOPRAMdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, ANDA077534, ANDA077042, ANDA077031, ANDA077289, ANDA0770 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., West-Ward Pharmaceuticals Corp, Cipla USA Inc., M ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 69097-822, 69097-823, 69097-824, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDERXCUI200371, 283672, 309314, 309313, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 23d9ce12-cfe2-4026-a3dd-6e177a9affb7, 24f9 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 0580 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36

5)

drugcharacterization2medicinalproductMEBEVERINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

Report Duplicate

duplicatesourceRANBAXYduplicatenumbGB-RANBAXY-2014RR-79613

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use