{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "5", "safetyreportid": "19865190", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20220424", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "1", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20210922", "receiptdateformat": "102", "receiptdate": "20220207", "fulfillexpeditecriteria": "1", "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-095203", "duplicate": "1", "reportduplicate": { "duplicatesource": "EXELIXIS", "duplicatenumb": "US-EXELIXIS-XL18421044159" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "53", "patientonsetageunit": "801", "patientweight": "69.3", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Posterior reversible encephalopathy syndrome", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CABOZANTINIB", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "9560", "drugcumulativedosageunit": "003", "drugdosagetext": "40 MILLIGRAM, QD", "drugadministrationroute": "048", "drugindication": "Renal cell carcinoma", "drugstartdateformat": "102", "drugstartdate": "20210114", "drugenddateformat": "102", "drugenddate": "20210927", "drugtreatmentduration": "257", "drugtreatmentdurationunit": "804", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CABOZANTINIB" }, "openfda": { "application_number": [ "NDA203756", "NDA208692" ], "brand_name": [ "COMETRIQ", "CABOMETYX" ], "generic_name": [ "CABOZANTINIB" ], "manufacturer_name": [ "Exelixis, Inc." ], "product_ndc": [ "42388-011", "42388-012", "42388-013", "42388-023", "42388-025", "42388-024" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1363273", "1363279", "1363281", "1363284", "1363312", "1363408", "1363409", "1363410", "1364580", "1364581", "1790161", "1790167", "1790169", "1790171", "1790173", "1790175" ], "spl_id": [ "03fee098-20c7-4a04-81a7-06fb7d8b1470", "e8cdcbdc-d863-4d48-af3e-a8926b9ab017" ], "spl_set_id": [ "1a0c3bea-c87b-4d25-bb44-5f0174da6b34", "3850cce2-6137-42e5-a792-d318c4a4b3b5" ], "package_ndc": [ "42388-011-14", "42388-012-14", "42388-013-14", "42388-023-26", "42388-023-46", "42388-023-36", "42388-023-37", "42388-023-57", "42388-025-26", "42388-025-46", "42388-025-37", "42388-025-57", "42388-024-26", "42388-024-46", "42388-024-37", "42388-024-57" ], "unii": [ "DR7ST46X58" ], "route": [ "ORAL" ], "substance_name": [ "CABOZANTINIB S-MALATE" ] } }, { "drugcharacterization": "1", "medicinalproduct": "NIVOLUMAB", "drugbatchnumb": "Unknown", "drugauthorizationnumb": "125554", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "007", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugcumulativedosagenumb": "33.479", "drugcumulativedosageunit": "007", "drugdosagetext": "3 MG/KG, Q3WEEKS, 4 DOSES", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": "Renal cell carcinoma", "drugstartdateformat": "102", "drugstartdate": "20210114", "drugenddateformat": "102", "drugenddate": "20210927", "drugtreatmentduration": "257", "drugtreatmentdurationunit": "804", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "openfda": { "application_number": [ "BLA125554" ], "brand_name": [ "OPDIVO" ], "generic_name": [ "NIVOLUMAB" ], "manufacturer_name": [ "E.R. 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JOSEPH LOW DOSE ASPIRIN", "CARDIASPIRIN PROTECT", "ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN", "MEDIQUE PRODUCTS ASPIRIN", "MEDI-FIRST ASPIRIN", "MEDI-FIRST PLUS ASPIRIN", "EQUALINE EFFERVESCENT PAIN RELIEVER", "ASPIRIN ENTERIC COATED LOW DOSE", "ADULT LOW STRENGTH ASPIRIN", "THOMPSON ASPIRIN", "LOW DOSE ASPIRIUN", "ULINE ASPIRIN" ], "generic_name": [ "ASPIRIN", "ASPIRIN 81 MG", "ASPIRIN 325 MG" ], "manufacturer_name": [ "Unifirst First Aid Corporation", "Health Pharma USA LLC", "Topco Associates, LLC", "Walgreen Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Advanced Rx LLC", "Chain Drug Marketing Association, Inc.", "Discount Drug Mart Inc", "STRATEGIC SOURCING SERVICES LLC", "L.N.K. International, Inc.", "Grocery Outlet", "Rising Pharma Holdings, Inc.", "HARRIS TEETER", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Trifecta Pharmaceuticals USA LLC", "Marc Glassman, Inc.", "Care One (Retail Business Services, LLC.)", "Geritrex LLC", "Cardinal Health 110, LLC. 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"53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022101", "NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATIVAN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "LORAZEPAM" }, "openfda": { "application_number": [ "NDA017794", "NDA018140" ], "brand_name": [ "ATIVAN" ], "generic_name": [ "LORAZEPAM" ], "manufacturer_name": [ "Bausch Health US LLC", "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0187-0063", "0187-0064", "0187-0065", "0641-6000", "0641-6003", "0641-6002", "0641-6001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "LORAZEPAM" ], "rxcui": [ "104719", "197900", "197901", "197902", "206821", "206828", "206819", "206820", "238100", "238101", "1665188", "1665190", "1665326", "1665327" ], "spl_id": [ "93bdf2de-1222-44a4-b4d5-2280f9ce58d8", "209b0091-c890-4f69-a693-d0594c2606fe" ], "spl_set_id": [ "89057c93-8155-4040-acec-64e877bd2b4c", "5fc0e987-61c9-40c4-b0d5-fcea07c8733e" ], "package_ndc": [ "0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALUMINUM HYDROXIDE\\MAGNESIUM TRISILICATE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ALUMINUM HYDROXIDE\\MAGNESIUM TRISILICATE" } }, { "drugcharacterization": "2", "medicinalproduct": "MORPHINE HYDROCHLORIDE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "MORPHINE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "REQUIP", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ROPINIROLE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "ADCIRCA", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "TADALAFIL" }, "openfda": { "application_number": [ "NDA022332" ], "brand_name": [ "ADCIRCA" ], "generic_name": [ "TADALAFIL" ], "manufacturer_name": [ "United Therapeutics Corporation" ], "product_ndc": [ "66302-467" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TADALAFIL" ], "rxcui": [ "849866", "2123194" ], "spl_id": [ "76c30323-0981-499c-b552-1a43f01c89c8" ], "spl_set_id": [ "ff61b237-be8e-461b-8114-78c52a8ad0ae" ], "package_ndc": [ "66302-467-60" ], "nui": [ "N0000175599", "N0000020026" ], "pharm_class_epc": [ "Phosphodiesterase 5 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 5 Inhibitors [MoA]" ], "unii": [ "742SXX0ICT" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20210909" } } } ] }