Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086852serious1Date Last Updated19/12/2018receiptdateformat102companynumbUS-TEVA-476809USAoccurcountryUSseriousnessother1duplicate1Date Received18/04/2014transmissiondate04/02/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age27Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionMaternal exposure during pregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionUnintended pregnancyOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugstartdateformat102drugstartdate05/04/2007actiondrug1drugadditional1

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

2)

drugcharacterization2medicinalproductMACROBIDdrugindicationURINARY TRACT INFECTION

activesubstance

activesubstancenameNITROFURANTOIN\NITROFURANTOIN MONOHYDRATE

openFDA Info on Medication

Application NumberNDA020064Brand NameMACROBIDGeneric NameNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEManufacturersAlmatica Pharma Inc.product_ndc52427-285Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNITROFURANTOIN, NITROFURANTOIN MONOHYDRATERXCUI539712, 1648755spl_id0ccd1a07-3321-8416-53f4-3552e68e402dspl_set_id8f270a9f-12a1-44d4-bc7e-873613555801Package NDC52427-285-01NUIN0000175494, M0014892Established Pharmacologic ClassNitrofuran Antibacterial [EPC]Chemical StructureNitrofurans [CS]UNII927AH8112L, E1QI2CQQ1I

3)

drugcharacterization2medicinalproductBIRTH CONTROL PILLS

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

4)

drugcharacterization1medicinalproductCLARAVISdrugstartdateformat102drugstartdate22/10/2010actiondrug1drugadditional1

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

5)

drugcharacterization1medicinalproductCLARAVISdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext3.3333 MILLIGRAM DAILY;drugstartdateformat102drugstartdate17/05/2013drugenddateformat102drugenddate04/04/2014actiondrug1drugadditional1

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

6)

drugcharacterization1medicinalproductCLARAVISdrugstartdateformat102drugstartdate14/01/2012actiondrug1drugadditional1

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: 20140324

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-476809USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use