Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10090147serious1Date Last Updated03/03/2015receiptdateformat102companynumbUS-BAYER-2014-055507occurcountryUSseriousnessother1duplicate1Date Received21/04/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age29Unit of Onset Ageyearspatientagegroup5Weight47.62SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionThrombosis

2)

reactionmeddraversionpt18.0ReactionPain

3)

reactionmeddraversionpt18.0ReactionMental disorder

4)

reactionmeddraversionpt18.0ReactionDeep vein thrombosis

5)

reactionmeddraversionpt18.0ReactionPulmonary embolism

6)

reactionmeddraversionpt18.0ReactionCerebrovascular accident

7)

reactionmeddraversionpt18.0ReactionAnxiety

8)

reactionmeddraversionpt18.0ReactionEmotional distress

9)

reactionmeddraversionpt18.0ReactionInjury

10)

reactionmeddraversionpt18.0ReactionDepression

Drug

1)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL DYSPHORIC DISORDERdrugstartdateformat602drugstartdate//2009drugenddateformat602drugenddate//2010

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

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)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL SYNDROMEdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

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

3)

drugcharacterization1medicinalproductOCELLAdrugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL DYSPHORIC DISORDERdrugstartdateformat602drugstartdate//2009drugenddateformat602drugenddate//2010

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameOCELLAGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersTEVA PHARMACEUTICALS USA, INC.product_ndc0555-9131Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 801185spl_id68b57216-cb7d-4a74-8ac9-4b2cc7b7d3cespl_set_id0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37Package NDC0555-9131-79, 0555-9131-67

4)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization1medicinalproductYASMINdrugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL DYSPHORIC DISORDERdrugstartdateformat602drugstartdate//2009drugenddateformat602drugenddate//2010

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_id0972cd1d-53a1-465e-b09c-5be40ef658cbspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

6)

drugcharacterization2medicinalproductCYMBALTAdrugdosagetextUNKdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_idb742d0a5-e67d-49ed-ba95-afe068f1d228spl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

7)

drugcharacterization2medicinalproductKLONOPINdrugdosagetextUNKdrugstartdateformat602drugstartdate//2006

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

8)

drugcharacterization1medicinalproductYASMINdrugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL SYNDROME

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_id0972cd1d-53a1-465e-b09c-5be40ef658cbspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

9)

drugcharacterization1medicinalproductOCELLAdrugdosageformFILM-COATED TABLETdrugindicationPREMENSTRUAL SYNDROME

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021098Brand NameOCELLAGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersTEVA PHARMACEUTICALS USA, INC.product_ndc0555-9131Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 801185spl_id68b57216-cb7d-4a74-8ac9-4b2cc7b7d3cespl_set_id0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37Package NDC0555-9131-79, 0555-9131-67

summary

narrativeincludeclinicalCASE EVENT DATE: 2010

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-055507

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use