Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10056022serious1Date Last Updated03/04/2014receiptdateformat102companynumbIT-JNJFOC-20140317321occurcountryITduplicate1Date Received03/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age44Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAgitationOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTOPIRAMATEdrugauthorizationnumb020505drugstructuredosagenumb10drugstructuredosageunit032drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1drugrecurreadministration2

openFDA Info on Medication

Application Number ANDA079162, ANDA078235, NDA020505, NDA020844, NDA205122, ANDA078877, ANDA207382, ... Brand NameTOPIRAMATE, TOPAMAX, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Golden State Medical Supply, Inc., Cadila Healthcare Limited, Cipla USA Inc., Zy ... product_ndc 60429-769, 60429-770, 60429-771, 60429-772, 65841-647, 65841-648, 65841-649, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 7b3298bf-7f7e-d7d0-e053-2a91aa0ab74b, ecd79705-832b-42c4-be26-82d93432cf7c, 6885 ... spl_set_id 5c44de38-a291-471d-8335-abc65e04387d, 57016639-89fe-43ad-89c4-5e7a756dddec, 4087 ... Package NDC 60429-769-60, 60429-769-05, 60429-769-10, 60429-770-60, 60429-770-05, 60429-770- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

2)

drugcharacterization1medicinalproductSERTRALINEdrugstructuredosagenumb10drugstructuredosageunit032drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1

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)

drugcharacterization1medicinalproductALPRAZOLAMdrugstructuredosagenumb10drugstructuredosageunit032drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

Report Duplicate

duplicatesourceJANSSENduplicatenumbIT-JNJFOC-20140317321

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use