Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-TEVA-388302USAoccurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10152416Date Received05/05/2014transmissiondate12/12/2014serious2Date Last Updated05/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionLiver function test abnormalOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb40drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate21/11/2012drugenddateformat102drugenddate15/02/2013actiondrug1drugrecurreadministration2

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization1medicinalproductMOTRIN

openFDA Info on Medication

Application NumberNDA020603, ANDA079113Brand NameMOTRIN INFANTS, MOTRIN PMGeneric NameIBUPROFEN, IBUPROFEN AND DIPHENHYDRAMINE CITRATEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-198, 50580-563Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN, DIPHENHYDRAMINE CITRATERXCUI204442, 854762, 895664, 895666spl_id3cdbe8dc-eb86-4c5f-8e5c-8bdd8a81b593, 6f68d6ba-ca5c-46d2-9b6e-f096cce12929spl_set_idc57f6ded-c0bd-45ae-823a-4c02ce334d98, 55403f19-58ae-450b-8a7b-0bc544088f20Package NDC 50580-198-50, 50580-198-51, 50580-198-52, 50580-563-20, 50580-563-40, 50580-563- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, 4OD433S209

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-388302USA