Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10090275serious1Date Last Updated21/04/2014receiptdateformat102companynumbUS-TEVA-476735USAoccurcountryUSseriousnessother1duplicate1Date Received21/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age18Unit of Onset AgeyearsSexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MILLIGRAM DAILY;drugindicationACNEdrugstartdateformat602drugstartdate//2014actiondrug1

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

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-476735USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use