Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10248318serious1Date Last Updated23/06/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0041178occurcountryUSseriousnessother1duplicate1Date Received20/06/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age57Unit of Onset AgeyearsWeight50.8SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionAbnormal behaviourOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionHypertensionOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionElectrocardiogram abnormalOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb20drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate30/05/2014drugenddateformat102drugenddate30/05/2014actiondrug1drugrecurreadministration3

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

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0041178

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use