Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10133499serious1Date Last Updated28/04/2014receiptdateformat102seriousnessdeath1companynumbCA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-18692CNoccurcountryCAduplicate1Date Received28/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryCA

Primary Source

reportercountryCAqualification5

Patient

Onset Age79Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRenal failureOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductPRADAXAdrugauthorizationnumb022512drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

openFDA Info on Medication

Application NumberNDA022512Brand NamePRADAXAGeneric NameDABIGATRAN ETEXILATE MESYLATEManufacturersBoehringer Ingelheim Pharmaceuticals Inc.product_ndc0597-0108, 0597-0355, 0597-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDABIGATRAN ETEXILATE MESYLATERXCUI1037045, 1037049, 1037179, 1037181, 1723476, 1723478spl_idfdeb89cd-11fc-4393-8fe7-a497e11a9cc8spl_set_idba74e3cd-b06f-4145-b284-5fd6b84ff3c9Package NDC 0597-0108-54, 0597-0108-60, 0597-0355-09, 0597-0355-56, 0597-0355-53, 0597-0360- ... UNIISC7NUW5IIT

2)

drugcharacterization2medicinalproductMETFORMINdrugadministrationroute065

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

3)

drugcharacterization2medicinalproductSPIRIVAdrugadministrationroute065

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

4)

drugcharacterization2medicinalproductZOLOFTdrugadministrationroute065

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)

drugcharacterization2medicinalproductMETOPROLOLdrugadministrationroute065

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

6)

drugcharacterization2medicinalproductALLOPURINOLdrugadministrationroute065

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA071450, ANDA204467, NDA018832, NDA018877, NDA016084, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Sun Pharmaceutical Industries, ... product_ndc 67457-978, 16729-134, 16729-135, 53489-156, 53489-157, 23155-693, 23155-694, 059 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, 9010eb1b-3580-b221-e053-2995a90a3feb, a9f5 ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, fd8f ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

7)

drugcharacterization2medicinalproductAMITRIPTYLINEdrugadministrationroute065

Report Duplicate

duplicatesourceBOEHRINGER INGELHEIMduplicatenumbCA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-18692CN

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use