Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1003476Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10206210Date Received27/05/2014transmissiondate28/05/2015serious1Date Last Updated20/10/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age22Unit of Onset AgeyearsWeight58.9SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionLymphadenopathy

2)

reactionmeddraversionpt18.0ReactionEye disorder

3)

reactionmeddraversionpt18.0ReactionAnal fissure

4)

reactionmeddraversionpt18.0ReactionConjunctival irritation

5)

reactionmeddraversionpt18.0ReactionNeoplasm

6)

reactionmeddraversionpt18.0ReactionPainful defaecation

7)

reactionmeddraversionpt18.0ReactionDry eye

8)

reactionmeddraversionpt18.0ReactionHaematochezia

9)

reactionmeddraversionpt18.0ReactionEyelid irritation

10)

reactionmeddraversionpt18.0ReactionConstipation

11)

reactionmeddraversionpt18.0ReactionMood altered

12)

reactionmeddraversionpt18.0ReactionHeadache

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate18/11/2013

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

2)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugenddateformat102drugenddate11/04/2014

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: 201402

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1003476