Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00194Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10442496Date Received08/09/2014transmissiondate26/03/2015serious1Date Last Updated23/09/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age18Unit of Onset AgeyearsWeight86.2SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionDisturbance in attention

2)

reactionmeddraversionpt17.1ReactionFeeling abnormal

3)

reactionmeddraversionpt17.1ReactionAnger

4)

reactionmeddraversionpt17.1ReactionErectile dysfunction

5)

reactionmeddraversionpt17.1ReactionDry skin

6)

reactionmeddraversionpt17.1ReactionCrying

7)

reactionmeddraversionpt17.1ReactionPenile erythema

8)

reactionmeddraversionpt17.1ReactionDermatitis

9)

reactionmeddraversionpt17.1ReactionDysuria

10)

reactionmeddraversionpt17.1ReactionHeadache

11)

reactionmeddraversionpt17.1ReactionMood swings

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugbatchnumb7802.022drugauthorizationnumb078485drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate03/05/2014drugenddateformat602drugenddate//2014drugadditional2

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: 2014

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00194