Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11012440transmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received10/04/2015receiptdateformat102Date Last Updated10/04/2015fulfillexpeditecriteria2

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age24Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionIncorrect dose administered

2)

reactionmeddraversionpt18.0ReactionHallucination, visual

Drug

1)

drugcharacterization1medicinalproductTOPIRAMATE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, QHS/BEDTIME/ ORALdrugadministrationroute048drugindicationMIGRAINE PROPHYLAXIS

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application Number ANDA215414, ANDA078462, ANDA078235, ANDA079162, NDA020505, NDA020844, NDA205122, ... Brand NameTOPIRAMATE, TOPAMAX, EPRONTIA, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Camber Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Cadila Healthcare Li ... product_ndc 31722-181, 31722-182, 31722-183, 31722-184, 16571-705, 16571-706, 16571-707, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 18aa4aae-c619-4a0e-a69e-b8c5bd7466bc, 9bb758cd-a042-4d34-ae5a-42769a8e4a36, ecd7 ... spl_set_id cefbc5f4-ef5f-4732-ab96-a69a183f0b6b, 296c5387-1bf4-4137-87f2-2ebab4933e2c, 5701 ... Package NDC 31722-181-60, 31722-181-05, 31722-182-60, 31722-182-05, 31722-183-60, 31722-183- ... 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)

drugcharacterization1medicinalproductESZOPICLONE.drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, QHS/BEDTIME, ORALdrugadministrationroute048drugindicationSLEEP DISORDER THERAPYdrugstartdateformat102drugstartdate01/04/2015drugenddateformat102drugenddate02/04/2015

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

summary

narrativeincludeclinicalCASE EVENT DATE: 20150402