Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-TEVA-488712USAoccurcountryCOVersion of Safety Report ID5receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10244215Date Received18/06/2014transmissiondate04/02/2019serious1Date Last Updated20/12/2018

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age24Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionMaternal exposure during pregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionVaginal haemorrhageOutcomeUnknown

3)

reactionmeddraversionpt21.1ReactionUnintended pregnancyOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductBIRTH CONTROL PILLS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

2)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext 20 MILLIGRAM DAILY; 1 WEEK OUT OF THE MONTH (20MG PER DAY) AROUND HER MENSTRUAL ... drugadministrationroute048drugindicationACNEdrugstartdateformat602drugstartdate//2005actiondrug1drugadditional1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20140418

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-488712USA