Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00065Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10301343Date Received08/07/2014transmissiondate26/03/2015serious1Date Last Updated14/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age23Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionUnintended pregnancy

2)

reactionmeddraversionpt17.1ReactionAbortion spontaneous

3)

reactionmeddraversionpt17.1ReactionExposure during pregnancy

4)

reactionmeddraversionpt17.1ReactionNasopharyngitis

5)

reactionmeddraversionpt17.1ReactionVaginal haemorrhage

6)

reactionmeddraversionpt17.1ReactionTreatment noncompliance

7)

reactionmeddraversionpt17.1ReactionInappropriate schedule of drug administration

8)

reactionmeddraversionpt17.1ReactionDrug dose omission

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugstartdateformat102drugstartdate07/05/2014drugenddateformat102drugenddate22/06/2014

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

2)

drugcharacterization2medicinalproductUNSPECIFED ORAL CONTRACEPTIVE PILLS

summary

narrativeincludeclinicalCASE EVENT DATE: 20140616

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00065