Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10196441serious1Date Last Updated27/05/2014receiptdateformat102companynumbUS-BAYER-2014-076890occurcountryUSduplicate1Date Received27/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age34Unit of Onset AgeyearsWeight93.88SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeep vein thrombosis

2)

reactionmeddraversionpt17.0ReactionPost thrombotic syndrome

3)

reactionmeddraversionpt17.0ReactionPain in extremity

Drug

1)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationACNEdrugstartdateformat102drugstartdate01/09/2009drugenddateformat102drugenddate29/12/2009actiondrug1

openFDA Info on Medication

Application NumberNDA021676Brand NameYAZGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-405Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 748856spl_idc138e16e-20a7-4893-9ff0-29f930446b38spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03

2)

drugcharacterization2medicinalproductSYNTHROIDdrugindicationHYPOTHYROIDISM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

3)

drugcharacterization2medicinalproductACCUTANEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate01/10/2009

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

4)

drugcharacterization2medicinalproductBIOTIN

openFDA Info on Medication

Brand NameHAIRJOY EYEBROW SIGNATURE, HAIRJOY EYELASH SIGNATUREGeneric NameBIOTINManufacturersHAIRJOYproduct_ndc69384-090, 69384-080Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsBIOTINspl_ide3180639-1e79-4ccd-be0d-119f17386386, 6159acee-5315-4e8f-b37b-88b4244c3cf8spl_set_ideb0813ab-dea6-4b13-b517-8e1ad1861c5d, ca42d0a4-b9f8-48b9-bd4c-8c669e31e772Package NDC69384-090-01, 69384-090-02, 69384-080-01, 69384-080-02UNII6SO6U10H04

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-076890

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use