Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10020929serious1Date Last Updated19/03/2014receiptdateformat102companynumbIL-JNJFOC-20140307429occurcountryILseriousnessother1duplicate1Date Received19/03/2014transmissiondate02/10/2014primarysourcecountryIL

Primary Source

reportercountryILqualification1

Patient

Onset Age37Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionManiaOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionForeign bodyOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionAbdominal painOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTOPIRAMATEdrugauthorizationnumb020505drugdosageformUnspecifieddrugadministrationroute048drugindicationDISTURBANCE IN SOCIAL BEHAVIOURactiondrug5drugrecurreadministration3

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)

drugcharacterization1medicinalproductRISPERIDONEdrugauthorizationnumb020272drugdosageformUnspecifieddrugadministrationroute065drugindicationDISTURBANCE IN SOCIAL BEHAVIOURactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077328, ANDA202386, ANDA076904, NDA020588, ANDA078116, ANDA079088, ANDA07851 ... Brand NameRISPERIDONE, PERSERIS, RISPERDAL, RISPERDAL M-TAB, RISPERDAL CONSTAGeneric NameRISPERIDONEManufacturers Dr. Reddy's Laboratories Limited, Lannett Company, Inc., Hikma Pharmaceuticals U ... product_ndc 55111-207, 55111-208, 55111-209, 55111-470, 55111-471, 54838-563, 0054-0063, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUSActive IngredientsRISPERIDONERXCUI 401953, 401954, 403825, 616698, 616705, 199387, 312828, 312829, 312830, 312831, ... spl_id 9293825e-f154-ffc9-20b0-5846d813b7ec, 95f6336f-cac0-40b5-a7ad-29df965445a1, af95 ... spl_set_id c00809e1-e632-f246-97d9-73e1f9804587, 1219dff4-0320-4530-b1ad-b6ecdac376cf, cd74 ... Package NDC 55111-207-81, 55111-207-78, 55111-207-79, 55111-208-81, 55111-208-78, 55111-208- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

3)

drugcharacterization1medicinalproductSERTRALINEdrugdosageformUnspecifieddrugadministrationroute065drugindicationDISTURBANCE IN SOCIAL BEHAVIOURactiondrug5

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

4)

drugcharacterization1medicinalproductCLOTIAPINEdrugdosageformUnspecifieddrugadministrationroute065drugindicationDISTURBANCE IN SOCIAL BEHAVIOURactiondrug5

Report Duplicate

duplicatesourceJANSSENduplicatenumbIL-JNJFOC-20140307429

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use