Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00170Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10412925Date Received25/08/2014transmissiondate26/03/2015serious1Date Last Updated25/08/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age20Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionBack pain

2)

reactionmeddraversionpt17.1ReactionIrritability

3)

reactionmeddraversionpt17.1ReactionHeadache

4)

reactionmeddraversionpt17.1ReactionAbdominal pain upper

Drug

1)

drugcharacterization1medicinalproductABSORICAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNE CYSTICdrugstartdateformat610drugstartdate/05/2014drugenddateformat610drugenddate/07/2014

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugindicationACNE CYSTICdrugstartdateformat610drugstartdate/07/2014drugenddateformat102drugenddate11/08/2014

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: 201408

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00170