Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10449713Date Received11/09/2014seriousnesshospitalization1transmissiondate26/03/2015serious1Date Last Updated11/09/2014seriousnesslifethreatening1primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age44Unit of Onset AgeyearsWeight72.58SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionPoisoning

2)

reactionmeddraversionpt17.1ReactionDepression

3)

reactionmeddraversionpt17.1ReactionMental impairment

4)

reactionmeddraversionpt17.1ReactionFacial nerve disorder

5)

reactionmeddraversionpt17.1ReactionMigraine

6)

reactionmeddraversionpt17.1ReactionHeadache

7)

reactionmeddraversionpt17.1ReactionBipolar disorder

8)

reactionmeddraversionpt17.1ReactionMuscle disorder

9)

reactionmeddraversionpt17.1ReactionAnxiety

10)

reactionmeddraversionpt17.1ReactionHead injury

11)

reactionmeddraversionpt17.1ReactionSuicidal ideation

12)

reactionmeddraversionpt17.1ReactionBurning sensation

13)

reactionmeddraversionpt17.1ReactionPain

14)

reactionmeddraversionpt17.1ReactionImpaired work ability

Drug

1)

drugcharacterization1medicinalproductACCUTANEdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationACNE

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: 20140818