Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10183859primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnesslifethreatening1seriousnesshospitalization1receivedateformat102Date Received20/05/2014receiptdateformat102Date Last Updated10/07/2014fulfillexpeditecriteria2companynumbUS-BAYER-2014-074235duplicate1

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-074235

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age51Unit of Onset Ageyearspatientagegroup5Weight72.56SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionAbdominal pain

2)

reactionmeddraversionpt17.1ReactionAnhedonia

3)

reactionmeddraversionpt17.1ReactionUterine perforation

4)

reactionmeddraversionpt17.1ReactionGeneral physical health deterioration

5)

reactionmeddraversionpt17.1ReactionDepression

6)

reactionmeddraversionpt17.1ReactionInjury

7)

reactionmeddraversionpt17.1ReactionAnxiety

8)

reactionmeddraversionpt17.1ReactionInfection

9)

reactionmeddraversionpt17.1ReactionEmotional distress

Drug

1)

drugcharacterization1medicinalproductMIRENAdrugbatchnumb71062Adrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformIntrauterine delivery systemdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate27/09/2007drugenddateformat102drugenddate14/07/2010actiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id21ce3b07-0588-4ac3-915b-d1c238d756easpl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

2)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, DAILYdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat602drugstartdate//2001

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

3)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

4)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MG, DAILYdrugadministrationroute048

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 857dd673-6ba8-485c-b96b-14291666b852, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

5)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb.125drugstructuredosageunit003drugdosagetext0.125 MG, UNKdrugadministrationroute048drugindicationTHYROIDECTOMYdrugstartdateformat602drugstartdate//1974

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

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_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_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

6)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, Q HSdrugadministrationroute048

activesubstance

activesubstancenameESZOPICLONE

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

7)

drugcharacterization1medicinalproductMIRENAdrugauthorizationnumb021225drugdosageformIntrauterine delivery systemdrugindicationMENORRHAGIAactiondrug1

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id21ce3b07-0588-4ac3-915b-d1c238d756easpl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

summary

narrativeincludeclinicalCASE EVENT DATE: 201007