Adverse Event Report

Report

reporttype1receiptdateformat102Version of Safety Report ID1receivedateformat102seriousnessother1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10412529Date Received26/08/2014transmissiondate26/03/2015serious1Date Last Updated26/08/2014primarysourcecountryUSseriousnessdisabling1

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age33Unit of Onset AgeyearsWeight65.77SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDisturbance in attention

2)

reactionmeddraversionpt17.1ReactionMood altered

3)

reactionmeddraversionpt17.1ReactionPersonality change

4)

reactionmeddraversionpt17.1ReactionEmotional disorder

5)

reactionmeddraversionpt17.1ReactionSuicidal ideation

6)

reactionmeddraversionpt17.1ReactionDepression

7)

reactionmeddraversionpt17.1ReactionAggression

8)

reactionmeddraversionpt17.1ReactionIrritability

9)

reactionmeddraversionpt17.1ReactionAbnormal behaviour

10)

reactionmeddraversionpt17.1ReactionFeelings of worthlessness

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 PILLS, ONCE DAILY, TAKEN BY MOUTHdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate01/05/2014drugenddateformat102drugenddate23/07/2014drugadditional1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140723