Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-TEVA-519049USAoccurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10611870Date Received26/11/2014transmissiondate20/07/2015serious2Date Last Updated12/02/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age41Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionDry skinOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionDry eyeOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionVomitingOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionPhotosensitivity reactionOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionDiarrhoeaOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionAbdominal painOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionMood alteredOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionAppetite disorderOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionLip dryOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionGastrointestinal disorderOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionContusionOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionNauseaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb40drugstructuredosageunit003drugdosageformCAPSULEactiondrug1

activesubstance

activesubstancenameISOTRETINOIN

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-519049USA