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

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
Drug
summary

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

Adverse Event Report