Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00018Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10276176Date Received01/07/2014transmissiondate26/03/2015serious1Date Last Updated21/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age27Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDecreased appetite

2)

reactionmeddraversionpt17.1ReactionDepressed mood

3)

reactionmeddraversionpt17.1ReactionFeelings of worthlessness

4)

reactionmeddraversionpt17.1ReactionDiarrhoea

5)

reactionmeddraversionpt17.1ReactionAggression

6)

reactionmeddraversionpt17.1ReactionSomnolence

7)

reactionmeddraversionpt17.1ReactionVomiting

8)

reactionmeddraversionpt17.1ReactionHeadache

9)

reactionmeddraversionpt17.1ReactionCrying

10)

reactionmeddraversionpt17.1ReactionMental disorder

11)

reactionmeddraversionpt17.1ReactionHostility

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, 1X/DAY, ORALdrugadministrationroute048drugindicationACNE CYSTICdrugstartdateformat102drugstartdate21/05/2014drugenddateformat102drugenddate29/05/2014drugadditional1

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)

drugcharacterization2medicinalproductUNSPECIFIED ORAL CONTRACEPTIVES

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

summary

narrativeincludeclinicalCASE EVENT DATE: 20140529

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00018