{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-01-27", "results": { "skip": 0, "limit": 1, "total": 78284 } }, "results": [ { "safetyreportversion": "8", "safetyreportid": "10188271", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20210419", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessdisabling": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140522", "receiptdateformat": "102", "receiptdate": "20210302", "fulfillexpeditecriteria": "1", "companynumb": "US-SA-2014SA035764", "duplicate": "1", "reportduplicate": { "duplicatesource": "SANOFI AVENTIS", "duplicatenumb": "US-SA-2014SA035764" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": 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"spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LANTUS SOLOSTAR", "drugbatchnumb": "3F613A", "drugauthorizationnumb": "021081", "drugstructuredosagenumb": "78", "drugstructuredosageunit": "025", "drugdosagetext": "78 IU", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "065", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "1991", "actiondrug": "3", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS SOLOSTAR" ], "generic_name": [ "INSULIN GLARGINE" ], 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"activesubstancename": "SEMAGLUTIDE" }, "openfda": { "application_number": [ "NDA209637", "NDA213051" ], "brand_name": [ "OZEMPIC" ], "generic_name": [ "SEMAGLUTIDE", "ORAL SEMAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk" ], "product_ndc": [ "0169-4130", "0169-4136", "0169-4132", "0169-4772", "0169-4181", "0169-1704", "0169-1715", "0169-1709", "0169-4303", "0169-4307", "0169-4314", "0169-4815", "0169-4804", "0169-4809" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "ORAL" ], "substance_name": [ "SEMAGLUTIDE" ], "rxcui": [ "1991306", "1991311", "1991316", "1991317", "2398841", "2398842", "2599362", "2599365", "2619152", "2619154", "2200644", "2200650", "2200652", "2200654", "2200656", "2200658", "2707547", "2707549", "2707551", "2707553", "2707555", "2707557", "2736944", "2736946", "2736948" ], "spl_id": [ "341dc8b9-9576-48a7-b8d8-c583c67b7007", "dfe441cd-c20f-452b-a8a5-3a6017b6b006" ], "spl_set_id": [ "adec4fd2-6858-4c99-91d4-531f5f2a2d79", "27f15fac-7d98-4114-a2ec-92494a91da98" ], "package_ndc": [ "0169-4136-11", "0169-4136-02", "0169-4132-90", "0169-4132-97", "0169-4132-11", "0169-4132-12", "0169-4130-01", "0169-4130-13", "0169-4772-11", "0169-4772-12", "0169-4772-90", "0169-4772-97", "0169-4181-03", "0169-4181-13", "0169-4181-90", "0169-4181-97", "0169-1715-30", "0169-1715-90", "0169-1704-30", "0169-1709-30", "0169-4303-01", "0169-4303-13", "0169-4303-90", "0169-4303-93", "0169-4303-30", "0169-4303-99", "0169-4307-01", "0169-4307-13", "0169-4307-30", "0169-4314-01", "0169-4314-13", "0169-4314-30", "0169-4815-30", "0169-4815-90", "0169-4804-30", "0169-4809-30" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "53AXN4NNHX" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2011" } } } ] }