Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1001767Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10047856Date Received11/03/2014transmissiondate02/10/2014serious1Date Last Updated11/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age16Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionDepression

2)

reactionmeddraversionpt17.0ReactionMood altered

3)

reactionmeddraversionpt17.0ReactionAggression

4)

reactionmeddraversionpt17.0ReactionCrying

5)

reactionmeddraversionpt17.0ReactionDecreased appetite

6)

reactionmeddraversionpt17.0ReactionHypersomnia

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationACNE CYSTICdrugstartdateformat102drugstartdate04/12/2013drugadditional1

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1001767