Report

Version of Safety Report ID2Safety Report ID10159401primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate26/03/2015reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received08/05/2014receiptdateformat102Date Last Updated29/09/2014fulfillexpeditecriteria1companynumbUS-BAYER-2014-065345duplicate1

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-065345

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age39Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionRenal infarct

2)

reactionmeddraversionpt17.1ReactionCerebral infarction

3)

reactionmeddraversionpt17.1ReactionAcute myocardial infarction

4)

reactionmeddraversionpt17.1ReactionInjury

5)

reactionmeddraversionpt17.1ReactionPain

Drug

1)

drugcharacterization1medicinalproductYAZdrugauthorizationnumb021676drugdosageformFILM-COATED TABLETdrugindicationACNE

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_id9184f52d-3cbf-4a4e-a153-0e2ea95e83f4spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03

2)

drugcharacterization1medicinalproductOCELLAdrugdosageformFILM-COATED TABLETdrugindicationACNE

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_id8913c148-8b7f-42ed-8e6a-744f1d568c3espl_set_id0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37Package NDC0555-9131-79, 0555-9131-67

3)

drugcharacterization2medicinalproductKLONOPIN

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductMETHYLPREDNISOLONEdrugstructuredosagenumb4drugstructuredosageunit003drugdosagetext4 MG, UNK

activesubstance

activesubstancenameMETHYLPREDNISOLONE

openFDA Info on Medication

Application Number NDA011153, ANDA209097, ANDA040189, ANDA040194, ANDA204072, ANDA212262, ANDA04018 ... Brand NameMEDROL, METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATEGeneric NameMETHYLPREDNISOLONEManufacturers Pharmacia and Upjohn Company LLC, Lupin Pharmaceuticals, Inc., BluePoint Laborat ... product_ndc 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 68180-685, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATERXCUI 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, ... spl_id 8f9c2163-1d7f-4e6e-bbe5-d758de474744, c71a649a-a46d-4e69-81b8-f65e77a4c48b, 6135 ... spl_set_id 39d5270b-d957-4821-93d6-501b7b9f02d4, c5cbcea1-2200-4fc0-a49a-35edd9434873, a91f ... Package NDC 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023, LEC9GKY20K

5)

drugcharacterization2medicinalproductALPRAZOLAM.drugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext0.5 MG, UNKdrugstartdateformat102drugstartdate14/10/2004drugenddateformat102drugenddate07/05/2006

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

6)

drugcharacterization2medicinalproductKETEK PAKdrugstructuredosagenumb400drugstructuredosageunit003drugdosagetext400 MG, UNK

7)

drugcharacterization2medicinalproductCOUMADINdrugindicationRENAL INFARCT

activesubstance

activesubstancenameWARFARIN SODIUM

openFDA Info on Medication

8)

drugcharacterization2medicinalproductRISPERDAL

activesubstance

activesubstancenameRISPERIDONE

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONERXCUI 104781, 104782, 104783, 104784, 199387, 211489, 262077, 262222, 312828, 312829, ... spl_idebac424e-3ee1-4b30-9bc5-739c8eb7f87fspl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

9)

drugcharacterization2medicinalproductLEXAPRO

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

10)

drugcharacterization2medicinalproductABILIFYdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

11)

drugcharacterization2medicinalproductPERPHENAZINE.drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, UNKdrugstartdateformat102drugstartdate27/10/2004drugenddateformat102drugenddate01/07/2005

activesubstance

activesubstancenamePERPHENAZINE

openFDA Info on Medication

Application NumberANDA040226, ANDA089685, ANDA205973, ANDA205232, ANDA205056, ANDA207582Brand NamePERPHENAZINEGeneric NamePERPHENAZINEManufacturers Par Pharmaceutical, Inc., Sandoz Inc, Wilshire Pharmaceuticals, Inc., Zydus Phar ... product_ndc 0603-5060, 0603-5061, 0603-5062, 0603-5063, 0781-8046, 0781-8047, 0781-8048, 078 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPERPHENAZINERXCUI198075, 198076, 198077, 198078spl_id ffd424c8-0c99-4036-9a10-53fd15cce72e, 5dd6b06f-cc54-4370-8665-f428049ffe2e, a59a ... spl_set_id 5fbfe9da-26e8-4705-98f3-42acd3d7b439, fc32500c-cc42-4f85-9cee-88f983fcbc16, 5e45 ... Package NDC 0603-5060-21, 0603-5060-28, 0603-5061-21, 0603-5061-28, 0603-5062-21, 0603-5062- ... NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIFTA7XXY4EZ

12)

drugcharacterization2medicinalproductGUAIFENEX PSEdrugdosagetext600/120

13)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG, UNK

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

14)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugstartdateformat102drugstartdate15/10/2004drugenddateformat102drugenddate07/05/2006

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

15)

drugcharacterization1medicinalproductYASMINdrugdosageformFILM-COATED TABLETdrugindicationACNE

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_ide83767a3-41e0-40b5-8c47-7b9912bb3b0fspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

16)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNKdrugstartdateformat102drugstartdate10/05/2005drugenddateformat102drugenddate04/03/2006

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_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_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

17)

drugcharacterization2medicinalproductLAMICTAL

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751, N0000187061, N0000000191Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Organic Cation Transporter 2 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor ... UNIIU3H27498KS

18)

drugcharacterization2medicinalproductADVAIR HFAdrugdosagetext500/50 DISKUSdrugstartdateformat102drugstartdate29/03/2005drugenddateformat102drugenddate03/05/2005

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id717071a8-e206-47f6-8e3f-c395d532ebd3spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNII6EW8Q962A5, O2GMZ0LF5W

summary

narrativeincludeclinicalCASE EVENT DATE: 20050716

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

1)

2)

3)

4)

5)

Drug

1)

activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

openFDA Info on Medication

9)

activesubstance

openFDA Info on Medication

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

openFDA Info on Medication

12)

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

activesubstance

openFDA Info on Medication

16)

activesubstance

openFDA Info on Medication

17)

activesubstance

openFDA Info on Medication

18)

activesubstance

openFDA Info on Medication

summary

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