Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1002631Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10067398Date Received07/04/2014transmissiondate12/12/2014serious1Date Last Updated12/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age23Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionFatigue

2)

reactionmeddraversionpt17.0ReactionLip dry

3)

reactionmeddraversionpt17.0ReactionMyalgia

4)

reactionmeddraversionpt17.0ReactionArthralgia

5)

reactionmeddraversionpt17.0ReactionHeadache

6)

reactionmeddraversionpt17.0ReactionMood altered

7)

reactionmeddraversionpt17.0ReactionDepression

8)

reactionmeddraversionpt17.0ReactionWeight decreased

9)

reactionmeddraversionpt17.0ReactionNight blindness

10)

reactionmeddraversionpt17.0ReactionVisual impairment

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate09/12/2013drugenddateformat102drugenddate21/03/2014

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)

drugcharacterization2medicinalproductORTHO TRI-CYCLEN LO

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1002631