Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00029Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10258241Date Received23/06/2014transmissiondate26/03/2015serious1Date Last Updated21/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age17Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionDry skin

2)

reactionmeddraversionpt17.1ReactionLip dry

3)

reactionmeddraversionpt17.1ReactionMood altered

4)

reactionmeddraversionpt17.1ReactionDry eye

5)

reactionmeddraversionpt17.1ReactionOral herpes

6)

reactionmeddraversionpt17.1ReactionDepression

7)

reactionmeddraversionpt17.1ReactionAnger

8)

reactionmeddraversionpt17.1ReactionDepressed mood

9)

reactionmeddraversionpt17.1ReactionScreaming

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationACNEdrugstartdateformat102drugstartdate04/11/2013drugenddateformat102drugenddate24/04/2014

activesubstance

activesubstancenameISOTRETINOIN

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140523

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00029