Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10142883primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate12/12/2014reporttype1serious1seriousnesshospitalization1seriousnessdisabling1receivedateformat102Date Received30/04/2014receiptdateformat102Date Last Updated08/05/2014fulfillexpeditecriteria2companynumbUS-BAYER-2014-062937duplicate1

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-062937

Primary Source

reportercountryUSqualification4

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPulmonary embolism

2)

reactionmeddraversionpt17.0ReactionDeep vein thrombosis

3)

reactionmeddraversionpt17.0ReactionIntracardiac thrombus

4)

reactionmeddraversionpt17.0ReactionInjury

5)

reactionmeddraversionpt17.0ReactionPain

6)

reactionmeddraversionpt17.0ReactionEmotional distress

7)

reactionmeddraversionpt17.0ReactionAnxiety

8)

reactionmeddraversionpt17.0ReactionFear of disease

9)

reactionmeddraversionpt17.0ReactionPain

Drug

1)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate09/02/2006drugenddateformat102drugenddate27/01/2007actiondrug1

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_ide83767a3-41e0-40b5-8c47-7b9912bb3b0fspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

2)

drugcharacterization1medicinalproductYAZdrugdosageformFILM-COATED TABLETdrugadministrationroute048

openFDA Info on Medication

Application NumberNDA021676Brand NameYAZGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-405Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 748856spl_id9184f52d-3cbf-4a4e-a153-0e2ea95e83f4spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03

3)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate09/02/2006drugenddateformat102drugenddate23/05/2006

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

4)

drugcharacterization2medicinalproductMULTIVITAMINdrugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate09/02/2006drugenddateformat102drugenddate23/05/2006