Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10416133Date Received27/08/2014seriousnesshospitalization1transmissiondate26/03/2015serious1Date Last Updated27/08/2014seriousnesslifethreatening1primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age27Unit of Onset AgeyearsWeight79.38SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionWeight decreased

2)

reactionmeddraversionpt17.1ReactionPolyuria

3)

reactionmeddraversionpt17.1ReactionAcne

4)

reactionmeddraversionpt17.1ReactionArthritis

5)

reactionmeddraversionpt17.1ReactionBreath odour

6)

reactionmeddraversionpt17.1ReactionAnxiety

7)

reactionmeddraversionpt17.1ReactionLibido decreased

8)

reactionmeddraversionpt17.1ReactionAlopecia

9)

reactionmeddraversionpt17.1ReactionDisturbance in attention

10)

reactionmeddraversionpt17.1ReactionArthropathy

11)

reactionmeddraversionpt17.1ReactionFeeling abnormal

12)

reactionmeddraversionpt17.1ReactionBlood glucose increased

13)

reactionmeddraversionpt17.1ReactionErectile dysfunction

14)

reactionmeddraversionpt17.1ReactionDepressed mood

Drug

1)

drugcharacterization1medicinalproductACCUTANEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 PILL ONCE DAILY TAKEN BY MOUTHdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate31/12/2009drugenddateformat102drugenddate30/06/2010drugadditional2

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: 20110218