{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 22291 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "16158713", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20201104", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20190404", "receiptdateformat": "102", "receiptdate": "20190506", "fulfillexpeditecriteria": "1", "companynumb": "US-AMGEN-USASP2019050408", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "US-AMGEN-USASP2019050408" }, "primarysource": { "reportercountry": "US", "qualification": "1", "literaturereference": "JULIA, HARPER. 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"70756-618-25", "70756-619-85", "70756-619-05", "70756-619-10", "70756-619-25", "70756-620-86", "70756-620-25", "70756-620-10" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VOXELOTOR.", "drugstructuredosagenumb": "1500", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1500 MILLIGRAM, QD", "drugadministrationroute": "065", "drugindication": "SICKLE CELL ANAEMIA", "drugstartdateformat": "102", "drugstartdate": "20170717", "drugenddateformat": "102", "drugenddate": "20171218", "activesubstance": { "activesubstancename": "VOXELOTOR" }, "openfda": { "application_number": [ "NDA213137", "NDA216157" ], "brand_name": [ "OXBRYTA" ], "generic_name": [ "VOXELOTOR" ], "manufacturer_name": [ "Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc." ], "product_ndc": [ "72786-101", "72786-111", "72786-102" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VOXELOTOR" ], "rxcui": [ "2265683", "2265689", "2588070", "2588074", "2619427", "2619428" ], "spl_id": [ "e27a3e07-438e-49d3-aae3-095e9379c7b4" ], "spl_set_id": [ "3c557fac-29ec-483f-b691-8a935d4decc3" ], "package_ndc": [ "72786-101-01", "72786-111-02", "72786-111-03", "72786-102-02", "72786-102-03" ], "nui": [ "N0000194027", "N0000194028", "N0000182141" ], "pharm_class_epc": [ "Hemoglobin S Polymerization Inhibitor [EPC]" ], "pharm_class_moa": [ "Hemoglobin S Polymerization Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]" ], "unii": [ "3ZO554A4Q8" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VOXELOTOR.", "drugstructuredosagenumb": "1800", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1800 MILLIGRAM, QD", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20180104", "drugenddateformat": "102", "drugenddate": "20180111", "activesubstance": { "activesubstancename": "VOXELOTOR" }, "openfda": { "application_number": [ "NDA213137", "NDA216157" ], "brand_name": [ "OXBRYTA" ], "generic_name": [ "VOXELOTOR" ], "manufacturer_name": [ "Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc." ], "product_ndc": [ "72786-101", "72786-111", "72786-102" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VOXELOTOR" ], "rxcui": [ "2265683", "2265689", "2588070", "2588074", "2619427", "2619428" ], "spl_id": [ "e27a3e07-438e-49d3-aae3-095e9379c7b4" ], "spl_set_id": [ "3c557fac-29ec-483f-b691-8a935d4decc3" ], "package_ndc": [ "72786-101-01", "72786-111-02", "72786-111-03", "72786-102-02", "72786-102-03" ], "nui": [ "N0000194027", "N0000194028", "N0000182141" ], "pharm_class_epc": [ "Hemoglobin S Polymerization Inhibitor [EPC]" ], "pharm_class_moa": [ "Hemoglobin S Polymerization Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]" ], "unii": [ "3ZO554A4Q8" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VOXELOTOR.", "drugstructuredosagenumb": "900", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "900 MILLIGRAM, QD", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20180215", "drugenddateformat": "102", "drugenddate": "20180215", "activesubstance": { "activesubstancename": "VOXELOTOR" }, "openfda": { "application_number": [ "NDA213137", "NDA216157" ], "brand_name": [ "OXBRYTA" ], "generic_name": [ "VOXELOTOR" ], "manufacturer_name": [ "Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc." ], "product_ndc": [ "72786-101", "72786-111", "72786-102" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VOXELOTOR" ], "rxcui": [ "2265683", "2265689", "2588070", "2588074", "2619427", "2619428" ], "spl_id": [ "e27a3e07-438e-49d3-aae3-095e9379c7b4" ], "spl_set_id": [ "3c557fac-29ec-483f-b691-8a935d4decc3" ], "package_ndc": [ "72786-101-01", "72786-111-02", "72786-111-03", "72786-102-02", "72786-102-03" ], "nui": [ "N0000194027", "N0000194028", "N0000182141" ], "pharm_class_epc": [ "Hemoglobin S Polymerization Inhibitor [EPC]" ], "pharm_class_moa": [ "Hemoglobin S Polymerization Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]" ], "unii": [ "3ZO554A4Q8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JADENU", "drugstructuredosagenumb": "720", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "720 MILLIGRAM, QD", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "DEFERASIROX" }, "openfda": { "application_number": [ "NDA206910", "NDA207968" ], "brand_name": [ "JADENU" ], "generic_name": [ "DEFERASIROX" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0654", "0078-0655", "0078-0656", "0078-0727", "0078-0713", "0078-0720" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEFERASIROX" ], "rxcui": [ "1607784", "1607790", "1607792", "1607794", "1607796", "1607798", "1923822", "1923825", "1923826", "1923827", "1923828", "1923829" ], "spl_id": [ "028e6158-3b78-41dd-99a8-6acb582f7245" ], "spl_set_id": [ "fee89140-fff1-4443-9f42-24ac004fcda1" ], "package_ndc": [ "0078-0654-15", "0078-0655-15", "0078-0656-15", "0078-0727-19", "0078-0727-15", "0078-0713-19", "0078-0713-15", "0078-0720-19", "0078-0720-15" ], "nui": [ "N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138" ], "pharm_class_moa": [ "Iron Chelating Activity [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]" ], "pharm_class_epc": [ "Iron Chelator [EPC]" ], "unii": [ "V8G4MOF2V9" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2003" } } } ] }