{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"0472-0235-16", "65219-042-21", "65219-042-71", "65219-044-21", "65219-044-71", "65219-046-21", "65219-046-71" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "44YRR34555" ] } }, { "drugcharacterization": "1", "medicinalproduct": "YAZ", "drugbatchnumb": "BS00CH9", "drugauthorizationnumb": "021676", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "CONTRACEPTION", "drugstartdateformat": "602", "drugstartdate": "2007", "drugenddateformat": "602", "drugenddate": "2011", "activesubstance": { "activesubstancename": "DROSPIRENONE\\ETHINYL ESTRADIOL" }, "openfda": { "application_number": [ "NDA021676" ], "brand_name": [ "YAZ" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-405" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "630734", "748797", "748798", "748856" ], "spl_id": [ "4f14f9c9-411b-48b0-a3d3-cac639cdfb8b" ], "spl_set_id": [ "065f33e4-b587-4e66-b896-ca9ab7b7c876" ], "package_ndc": [ "50419-405-03" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201110" } } }, { "safetyreportversion": "1", "safetyreportid": "10005355", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "US-UCBSA-114540", "duplicate": "1", "reportduplicate": { "duplicatesource": "UCB", "duplicatenumb": "US-UCBSA-114540" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "0", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Death", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LEVETIRACETAM", "drugauthorizationnumb": "021872", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugdosagetext": "LOADING DOSE", "drugdosageform": "INJECTION", "drugadministrationroute": "042", "drugindication": "CONVULSION PROPHYLAXIS", "openfda": { "application_number": [ "ANDA217878", "ANDA205130", "NDA204417", "ANDA219562", "ANDA090515", "ANDA201157", "ANDA078904", "ANDA209781", "NDA021872", "ANDA091399", "ANDA078858", "ANDA078106", "ANDA078582", "ANDA079063", "ANDA203052", "ANDA078234", "ANDA078774", "ANDA215980", "ANDA206880", "ANDA090876", "ANDA090981", "ANDA078154", "ANDA090025", "ANDA215069", "ANDA091261", "ANDA202958", "ANDA207160", "ANDA202869", "ANDA213532", "ANDA076920", "NDA202543", "NDA207958", "ANDA090263", "ANDA091338", "ANDA212688", 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"0115-9942-01", "70771-1514-3", "70771-1514-9", "70771-1514-5", "70771-1514-2", "70771-1514-4", "70771-1515-3", "70771-1515-9", "70771-1515-5", "70771-1515-2", "70771-1515-4", "70771-1516-3", "70771-1516-9", "70771-1516-5", "70771-1516-2", "70771-1516-4", "70771-1517-3", "70771-1517-9", "70771-1517-5", "70771-1517-2", "70771-1517-4", "70771-1518-3", "70771-1518-9", "70771-1518-5", "70771-1518-2", "70771-1518-4", "70771-1519-3", "70771-1519-9", "70771-1519-5", "70771-1519-2", "70771-1519-4", "16571-785-01", "16571-786-01" ], "nui": [ "N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191" ], "pharm_class_epc": [ "Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_moa": [ "Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]" ], "unii": [ "U3H27498KS" ] } } ] } } ] }