Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10066166serious1Date Last Updated08/04/2014receiptdateformat102companynumbPHHY2014IT038926occurcountryITduplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification3

Patient

Onset Age44Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAgitationOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionConfusional stateOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTOPIRAMATEdrugstructuredosagenumb10drugstructuredosageunit032drugdosagetext10 DF, ONCE/SINGLEdrugdosageformTABLETdrugadministrationroute048drugindicationDRUG ABUSEdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductLORAZEPAMdrugauthorizationnumb071193drugstructuredosagenumb10drugstructuredosageunit032drugdosagetext10 DF, ONCE/SINGLEdrugdosageformTABLETdrugadministrationroute048drugindicationDRUG ABUSEdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, West-Ward Pharmaceuticals Corp., Auro ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 763028, 763029spl_id decb713d-bc45-4bf5-8f61-c0e2f23051b0, eb500b8e-b94e-4900-bc8a-8217fc718704, e1fa ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-10, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

3)

drugcharacterization1medicinalproductSERTRALINEdrugstructuredosagenumb10drugstructuredosageunit032drugdosagetext10 DF, ONCE/SINGLEdrugadministrationroute048drugindicationDRUG ABUSEdrugstartdateformat102drugstartdate15/02/2014drugenddateformat102drugenddate15/02/2014actiondrug1drugrecurreadministration3

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

Report Duplicate

duplicatesourceSANDOZduplicatenumbPHHY2014IT038926

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use