Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10420681Date Received29/08/2014transmissiondate26/03/2015serious1Date Last Updated29/08/2014primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age41Unit of Onset AgeyearsWeight65.77SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionDry skin

2)

reactionmeddraversionpt17.1ReactionBehcet^s syndrome

3)

reactionmeddraversionpt17.1ReactionAbdominal pain upper

4)

reactionmeddraversionpt17.1ReactionHaematochezia

5)

reactionmeddraversionpt17.1ReactionEpistaxis

6)

reactionmeddraversionpt17.1ReactionIrritable bowel syndrome

Drug

1)

drugcharacterization1medicinalproductACCUTANEdrugauthorizationnumb018662drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 A DAY ONCE DAILY TAKEN BY MOUTHdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate01/07/1989drugenddateformat102drugenddate25/12/1989drugadditional2

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20130416