Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID13242414serious1Date Last Updated16/02/2017receiptdateformat102authoritynumbUS-FDA-363257occurcountryUSseriousnessother1Date Received16/02/2017seriousnesshospitalization1transmissiondate28/04/2017primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification5

Patient

Onset Age29Unit of Onset AgeyearsWeight58.5SexMale

Reaction

1)

reactionmeddraversionpt19.1ReactionDepression

2)

reactionmeddraversionpt19.1ReactionSuicidal ideation

3)

reactionmeddraversionpt19.1ReactionInflammatory bowel disease

4)

reactionmeddraversionpt19.1ReactionCrohn^s disease

5)

reactionmeddraversionpt19.1ReactionVision blurred

6)

reactionmeddraversionpt19.1ReactionChronic fatigue syndrome

7)

reactionmeddraversionpt19.1ReactionMood swings

8)

reactionmeddraversionpt19.1ReactionIrritability

9)

reactionmeddraversionpt19.1ReactionAnxiety

Drug

1)

drugcharacterization1medicinalproductACCUTANEdrugauthorizationnumb99drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate08/02/2007drugenddateformat102drugenddate01/07/2007drugadditional2

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: 20070208

Report Duplicate

duplicatesourceFDA-CTU

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use