{ "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": "1", "safetyreportid": "21107022", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20221027", "reporttype": "1", "serious": "2", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20220720", "receiptdateformat": "102", "receiptdate": "20220720", "fulfillexpeditecriteria": "2", "companynumb": "US-JAZZ-2022-US-015562", "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "EPIDIOLEX", "drugstructuredosagenumb": "2.2", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "12", "drugintervaldosagedefinition": "805", "drugdosagetext": "2.2 MILLILITRE, BID WITH FOOD", "drugdosageform": "Oral solution", "drugindication": "Lennox-Gastaut syndrome", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "CANNABIDIOL" }, "openfda": { "application_number": [ "NDA210365" ], "brand_name": [ "EPIDIOLEX" ], "generic_name": [ "CANNABIDIOL" ], "manufacturer_name": [ "Jazz Pharmaceuticals, Inc." ], "product_ndc": [ "70127-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CANNABIDIOL" ], "rxcui": [ "2058900", "2058906" ], "spl_id": [ "1eb7ac65-8df5-4a4a-9156-802cfaa92b06" ], "spl_set_id": [ "8bf27097-4870-43fb-94f0-f3d0871d1eec" ], "package_ndc": [ "70127-100-01", "70127-100-10", "70127-100-06", "70127-100-60" ], "nui": [ "M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]" ], "unii": [ "19GBJ60SN5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ONFI", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "CLOBAZAM" }, "openfda": { "application_number": [ "NDA203993", "NDA202067" ], "brand_name": [ "ONFI" ], "generic_name": [ "CLOBAZAM" ], "manufacturer_name": [ "Lundbeck Pharmaceuticals LLC" ], "product_ndc": [ "67386-313", "67386-314", "67386-315" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CLOBAZAM" ], "rxcui": [ "199450", "246172", "1191056", "1191058", "1366192", "1366196" ], "spl_id": [ "68dbe31c-2dbe-49ad-8b2e-2cf1b8521167" ], "spl_set_id": [ "de03bd69-2dca-459c-93b4-541fd3e9571c" ], "package_ndc": [ "67386-314-01", "67386-315-01", "67386-313-21" ], "nui": [ "N0000175694", "M0002356", "N0000182137", "N0000185506" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]" ], "unii": [ "2MRO291B4U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "KEPPRA", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "openfda": { "application_number": [ "NDA021872", "NDA021505", "NDA021035", "NDA022285" ], "brand_name": [ "KEPPRA", "KEPPRA XR" ], "generic_name": [ "LEVETIRACETAM" ], "manufacturer_name": [ "UCB, Inc." ], "product_ndc": [ "50474-002", "50474-001", "50474-594", "50474-595", "50474-596", "50474-597", "50474-598", "50474-599" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "LEVETIRACETAM" ], "rxcui": [ "647121", "647123", "261335", "261336", "284391", "311288", "311289", "311290", "387003", "403884", "404595", "630807", "807832", "807834", "846378", "847673" ], "spl_id": [ "38cabb23-4e04-9a05-e063-6394a90a2a94", "4974b225-87ca-610e-e063-6294a90ad20a", "38534148-3717-03b3-e063-6394a90a0f1e" ], "spl_set_id": [ "c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e", "3ca9df05-a506-4ec8-a4fe-320f1219ab21", "2919e43b-69a8-434c-a2d2-1f3ecd7554c0" ], "package_ndc": [ "50474-002-63", "50474-594-40", "50474-595-40", "50474-596-40", "50474-597-66", "50474-001-48", "50474-599-66", "50474-598-66" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "44YRR34555" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALBUTEROL", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "ALBUTEROL" }, "openfda": { "application_number": [ "ANDA219409", "ANDA213657", "ANDA208804", "ANDA207046", "ANDA214531", "ANDA208884" ], "brand_name": [ "ALBUTEROL" ], "generic_name": [ "ALBUTEROL SULFATE", "ALBUTEROL" ], "manufacturer_name": [ "Cipla USA Inc.", "Aurobindo Pharma Limited", "Amneal Pharmaceuticals NY LLC", "Rising Pharma Holdings, Inc.", "Mylan Pharmaceuticals Inc.", "Zydus Pharmaceuticals USA Inc.", "Zydus Lifesciences Limited" ], "product_ndc": [ "69097-021", "59651-333", "59651-334", "69238-1344", "69238-1345", "64980-442", "64980-443", "0378-7057", "0378-7058", "70710-1061", "70710-1062", "70771-1511", "70771-1512" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)", "ORAL" ], "substance_name": [ "ALBUTEROL SULFATE" ], "rxcui": [ "2123076", "197316", "197318", "351136", "351137" ], "spl_id": [ "7d4c1e96-c05f-4ffc-80b6-988986a061bc", "f89dffb1-5c4b-48aa-90b4-74043fc9b690", "efcb5cab-b9c0-4ef9-84fc-5f321c13a0ed", "f3d2f709-6e2e-4c25-8069-52661dc76e2d", "6e4e9eff-5117-47b1-a43f-58a45cd90457", "1d5b3219-efd5-4842-9b6e-2ea1874d0d4d", "f4ea29a0-b1df-4ca8-9438-1f0300eb6d9d" ], "spl_set_id": [ "fd0389e0-3713-42e0-8ef2-3bb97676fded", "ff9b287b-e4a4-4c12-ad2f-6b7d55b20dc6", "230d66fc-f62c-42a6-adb3-0a0f879c8ad4", "40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c", "9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6", "c3fa0068-fd12-45de-818e-e929fb45ba05", "a4709eea-e4a2-46e2-850f-1e6afca01893" ], "package_ndc": [ "69097-021-60", "59651-333-01", "59651-333-05", "59651-334-01", "59651-334-05", "69238-1344-1", "69238-1344-5", "69238-1345-1", "69238-1345-5", "64980-442-01", "64980-442-50", "64980-443-01", "64980-443-50", "0378-7057-98", "0378-7057-52", "0378-7058-98", "0378-7058-52", "70710-1061-1", "70710-1062-1", "70710-1062-5", "70771-1511-1", "70771-1512-1", "70771-1512-5" ], "unii": [ "021SEF3731" ] } } ] } } ] }