Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10374257serious1Date Last Updated10/10/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0042330occurcountryUSseriousnessother1duplicate1Date Received11/08/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age26Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionSelective abortionOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionDrug dose omission

3)

reactionmeddraversionpt18.0ReactionInappropriate schedule of drug administration

4)

reactionmeddraversionpt18.0ReactionExposure during pregnancyOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionPregnancy on oral contraceptive

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/03/2014drugenddateformat102drugenddate19/07/2014

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductORTHO TRI CYCLEN LOdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2013

activesubstance

activesubstancenameETHINYL ESTRADIOL\NORGESTIMATE

summary

narrativeincludeclinicalCASE EVENT DATE: 20140903

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0042330

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use