Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10090420serious1Date Last Updated28/07/2014receiptdateformat102companynumbUS-BAYER-2014-057995occurcountryUSduplicate1Date Received21/04/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age46Unit of Onset Ageyearspatientagegroup5Weight86.17SexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionPulmonary embolism

2)

reactionmeddraversionpt17.1ReactionInjury

Drug

1)

drugcharacterization2medicinalproductCEPHALEXIN.drugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate14/04/2005drugenddateformat102drugenddate03/06/2009

activesubstance

activesubstancenameCEPHALEXIN

openFDA Info on Medication

Application Number ANDA065253, ANDA090836, ANDA065152, NDA050405, ANDA065444, ANDA065234, ANDA06533 ... Brand NameCEPHALEXIN, KEFLEXGeneric NameCEPHALEXINManufacturers AMELLA PHARMA, LLC, Cronus Pharma LLC, AvPAK, Pharma-C, Inc., Fera Pharmaceutica ... product_ndc 72287-310, 69043-008, 69043-009, 50268-151, 50268-152, 69778-930, 69778-931, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCEPHALEXINRXCUI 309114, 309112, 637173, 309110, 309113, 645617, 212306, 212339, 637175, 197454, ... spl_id 9ceaceed-1674-4e6d-8baf-44c4693549b3, a4e861e2-5803-4c4a-a962-92f5755e1ab5, 9c95 ... spl_set_id 602fae70-3b8a-4f09-8db1-41fef4a2ecd7, a4e861e2-5803-4c4a-a962-92f5755e1ab5, 5975 ... Package NDC 72287-310-01, 69043-008-01, 69043-008-05, 69043-009-01, 69043-009-05, 50268-152- ... UNIIOBN7UDS42Y

2)

drugcharacterization2medicinalproductPREVACIDdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb30780drugcumulativedosageunit003drugdosagetext30 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate09/09/2002drugenddateformat102drugenddate30/06/2005

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application NumberNDA020406, NDA022327Brand NamePREVACID, PREVACID 24 HRGeneric NameLANSOPRAZOLEManufacturers Takeda Pharmaceuticals America, Inc., GlaxoSmithKline Consumer Healthcare Holdin ... product_ndc64764-046, 64764-541, 64764-543, 64764-544, 0067-6286Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI206205, 206206, 311277, 351260, 351261, 596843, 596918, 866152spl_ide9cb8e8b-589a-4d5d-9615-4bbd8dda0033, f2b830fb-0c23-494a-9d4c-76748dd7e1c6spl_set_id71ba78cb-7e46-43eb-9425-fa130f537f84, fd4629d5-b876-4ae9-bb32-c3560ad416a9Package NDC 64764-541-30, 64764-541-19, 64764-541-11, 64764-541-05, 64764-046-13, 64764-046- ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

3)

drugcharacterization2medicinalproductPROCHLORPERAZINE.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugstartdateformat102drugstartdate04/04/2005drugenddateformat102drugenddate26/04/2010

activesubstance

activesubstancenamePROCHLORPERAZINE

openFDA Info on Medication

Application NumberANDA040058, ANDA040246Brand NamePROCHLORPERAZINE, COMPROGeneric NamePROCHLORPERAZINEManufacturersCosette Pharmaceuticals, Inc., Paddock Laboratories, LLCproduct_ndc0713-0135, 0574-7226Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsPROCHLORPERAZINERXCUI198159, 284254spl_idca1e6e40-c2e6-46a6-ad10-6a881d91e1e3, 9fece974-eb12-49e0-8975-97b0b9a1b27cspl_set_id9595346e-76e5-e155-341b-ffaaafb885ab, ea381bc5-0957-4c91-826a-0ff680cebaccPackage NDC0713-0135-12, 0713-0135-10, 0574-7226-12NUIN0000175746, M0016525Established Pharmacologic ClassPhenothiazine [EPC]Chemical StructurePhenothiazines [CS]UNIIYHP6YLT61T

4)

drugcharacterization1medicinalproductCOUMADINdrugindicationPULMONARY EMBOLISM

activesubstance

activesubstancenameWARFARIN SODIUM

openFDA Info on Medication

5)

drugcharacterization2medicinalproductMEPERIDINEdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate04/04/2005

activesubstance

activesubstancenameMEPERIDINE

6)

drugcharacterization2medicinalproductZOLOFT

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

7)

drugcharacterization2medicinalproductACETAMINOPHEN + COD. PHOSP.drugdosagetextUNKdrugadministrationroute048drugstartdateformat102drugstartdate04/04/2005

8)

drugcharacterization2medicinalproductCYCLOBENZAPRINEdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate19/04/2005

activesubstance

activesubstancenameCYCLOBENZAPRINE

openFDA Info on Medication

Application NumberANDA090478, ANDA071611Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEGeneric NameCYCLOBENZAPRINE, CYCLOBENZAPRINE HYDROCHLORIDEManufacturersCipla USA Inc., Rising Health, LLCproduct_ndc69097-845, 69097-846, 57237-266Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828320, 828348, 828299spl_idfb272847-c855-4abb-b9dd-0d7a4b92bef0, 09330886-13f8-44cc-98d2-883f3e0514b4spl_set_id575a31fb-04c5-4001-88a7-c33adbacc6a8, b12fb4ea-182e-462b-b6ed-cfd2f6bb71e8Package NDC69097-845-07, 69097-845-15, 69097-846-07, 69097-846-15, 57237-266-01UNII0VE05JYS2P

9)

drugcharacterization2medicinalproductATIVAN

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

10)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosageformFILM-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

11)

drugcharacterization2medicinalproductDIAZEPAM.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QD AS NEEDEDdrugadministrationroute048drugstartdateformat102drugstartdate01/04/2005

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

12)

drugcharacterization2medicinalproductMETRONIDAZOLE.drugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, UNKdrugadministrationroute048drugstartdateformat102drugstartdate26/04/2005

activesubstance

activesubstancenameMETRONIDAZOLE

openFDA Info on Medication

Application Number ANDA077264, ANDA077549, ANDA070772, NDA020208, NDA018657, ANDA070027, ANDA070033 ... Brand Name METRONIDAZOLE, ROSADAN, FLAGYL, METRONIDAZOLE 500 MG, METRONIDAZOLE TOPICAL GEL, ... Generic NameMETRONIDAZOLEManufacturers Sandoz Inc., Cosette Pharmaceuticals, Inc., AMICI PHARMACEUTICALS LLC, Oceanside ... product_ndc 0781-7077, 0713-0757, 69292-208, 68682-455, 0338-1055, 50111-333, 50111-334, 516 ... Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAVENOUSActive IngredientsMETRONIDAZOLERXCUI 142046, 311678, 311681, 311683, 314106, 311679, 199055, 1148398, 207287, 207290, ... spl_id a00b814a-ba5f-4af8-b50d-fa231339148b, 7c04e645-f7ea-4931-9451-05bd8d55bece, 3fe7 ... spl_set_id 0030514f-879d-416d-b422-24b67e334b36, 5a7065b2-e729-46d5-8da5-865dc1ea58f7, 9f1f ... Package NDC 0781-7077-87, 0713-0757-37, 69292-208-01, 69292-208-50, 68682-455-70, 0338-1055- ... NUIN0000175435, M0014907Established Pharmacologic ClassNitroimidazole Antimicrobial [EPC]Chemical StructureNitroimidazoles [CS]UNII140QMO216E

13)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugindicationHORMONE THERAPYdrugstartdateformat102drugstartdate01/04/2003drugenddateformat602drugenddate//2005

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

14)

drugcharacterization2medicinalproductCIPROFLOXACIN.

activesubstance

activesubstancenameCIPROFLOXACIN

openFDA Info on Medication

Application Number NDA207986, ANDA076555, ANDA075817, ANDA076912, ANDA078252, ANDA078024, NDA021918 ... Brand NameOTIPRIO, CIPROFLOXACIN, CIPROFLOXACIN OTIC, CETRAXAL, CIPROGeneric NameCIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN TABLETSManufacturers Otonomy, Inc., Akorn Inc., Mylan Pharmaceuticals Inc., Taro Pharmaceuticals U.S. ... product_ndc 69251-201, 17478-714, 0378-7098, 51672-4085, 51672-4086, 51672-4087, 25021-114, ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRATYMPANIC, OPHTHALMIC, ORAL, INTRAVENOUS, AURICULAR (OTIC)Active IngredientsCIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEspl_id 44d2ab10-db38-11ea-8b6e-0800200c9a66, db2c7634-1640-48ed-aead-ec5669ef86b7, 047b ... spl_set_id 8365e37a-0b35-497c-aab4-f25053378154, 3e9a6174-962b-400e-8ca7-4a6c32c60a5d, a9a6 ... Package NDC 69251-201-01, 17478-714-25, 17478-714-10, 17478-714-11, 0378-7098-01, 51672-4085 ... NUIN0000175937, M0023650Established Pharmacologic ClassQuinolone Antimicrobial [EPC]Chemical StructureQuinolones [CS]UNII5E8K9I0O4U, 4BA73M5E37RXCUI 309307, 309309, 197511, 197512, 1665210, 1665212, 1665227, 1665229, 848956, 1993 ...

summary

narrativeincludeclinicalCASE EVENT DATE: 20050630

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2014-057995

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use