{ "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": "16616052", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20191004", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20190723", "receiptdateformat": "102", "receiptdate": "20190723", "fulfillexpeditecriteria": "2", "reportduplicate": { "duplicatesource": "FDA-CTU" }, "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "20", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Seizure" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Condition aggravated" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "PHENOBARBITAL 64.8MG", "activesubstance": { "activesubstancename": "PHENOBARBITAL" } }, { "drugcharacterization": "1", "medicinalproduct": "EPIDIOLEX", "drugbatchnumb": "N/A", "drugstructuredosagenumb": "3.5", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "033", "drugindication": "LENNOX-GASTAUT SYNDROME", "drugstartdateformat": "102", "drugstartdate": "20190607", "drugadditional": "1", "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": "KEPPRA", "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": "SINGULAIR", "activesubstance": { "activesubstancename": "MONTELUKAST SODIUM" }, "openfda": { "application_number": [ "NDA020830", "NDA021409", "NDA020829" ], "brand_name": [ "SINGULAIR" ], "generic_name": [ "MONTELUKAST SODIUM" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-170", "78206-171", "78206-173", "78206-172" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MONTELUKAST SODIUM" ], "rxcui": [ "153892", "153893", "200224", "242438", "261367", "311759", "351246", "404406" ], "spl_id": [ "57a12189-3bb3-4a5d-b5fe-fc57db87c134" ], "spl_set_id": [ "482dcc92-b47f-4ea6-854a-f5ac2aea7842" ], "package_ndc": [ "78206-171-01", "78206-170-01", "78206-173-01", "78206-172-01", "78206-172-02" ], "unii": [ "U1O3J18SFL" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LAMICTAL", "activesubstance": { "activesubstancename": "LAMOTRIGINE" }, "openfda": { "application_number": [ "NDA020764", "NDA020241", "NDA022251", "NDA022115" ], "brand_name": [ "LAMICTAL", "LAMICTAL ODT", "LAMICTAL XR" ], "generic_name": [ "LAMOTRIGINE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0526", "0173-0633", "0173-0642", "0173-0643", "0173-0644", "0173-0699", "0173-0527", "0173-0772", "0173-0774", "0173-0776", "0173-0777", "0173-0594", "0173-0779", "0173-0780", "0173-0778", "0173-0817", "0173-0754", "0173-0755", "0173-0756", "0173-0757", "0173-0758", "0173-0760", "0173-0759", "0173-0761", "0173-0781" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LAMOTRIGINE" ], "rxcui": [ "103968", "105018", "105019", "108782", "198427", "198428", "198429", "198430", "201239", "201240", "206201", "252478", "252479", "282401", "311264", "311265", "349010", "542426", "751139", "751563", "753451", "795772", "795774", "795778", "849049", "849050", "849051", "849052", "851748", "851749", "851750", "851751", "851752", "851753", "850087", "850091", "900145", "900156", "900157", "900164", "900165", "900169", "900865", "900866", "900890", "900891", "900983", "900984", "1098608", "1098610", "1146690", "1146692" ], "spl_id": [ "076c76e0-4a5e-491b-ba85-de2dd757b436", "d0cca76f-809f-4db8-a468-619a217debc1" ], "spl_set_id": [ "d7e3572d-56fe-4727-2bb4-013ccca22678", "3e2c9a35-6a39-41d7-ad84-3c0bb8894b09" ], "package_ndc": [ "0173-0633-02", "0173-0633-10", "0173-0642-55", "0173-0643-60", "0173-0644-60", "0173-0699-02", "0173-0699-00", "0173-0526-00", "0173-0527-00", "0173-0772-02", "0173-0774-02", "0173-0776-02", "0173-0777-02", "0173-0594-02", "0173-0779-00", "0173-0780-00", "0173-0778-00", "0173-0817-28", "0173-0754-00", "0173-0755-00", "0173-0756-00", "0173-0757-00", "0173-0758-00", "0173-0760-00", "0173-0759-00", "0173-0761-00", "0173-0781-00" ], "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CLARITIN", "activesubstance": { "activesubstancename": "LORATADINE" }, "openfda": { "application_number": [ "NDA020704", "NDA020641", "ANDA075209", "NDA019658", "ANDA210033", "NDA021891", "NDA021993" ], "brand_name": [ "CLARITIN REDITABS", "CLARITIN ALLERGY", "CLARITIN" ], "generic_name": [ "LORATADINE", "LORATADINE TABLET" ], "manufacturer_name": [ "Bayer Healthcare LLC.", "Bayer HealthCare LLC.", "Lil' Drug Store Products, Inc.", "Bayer HealthCare LLC" ], "product_ndc": [ "11523-4329", "11523-7157", "11523-0101", "11523-0007", "66715-9742", "11523-6655", "11523-0800", "11523-1527", "11523-7237", "11523-7160", "11523-4359", "11523-0104", "11523-4328", "11523-4331", "11523-7202", "11523-4330" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LORATADINE" ], "rxcui": [ "311373", "744830", "692783", "755476", "206805", "311372", "665078", "668469", "672558", "904026" ], "spl_id": [ "4536fe84-5b46-ca4c-e063-6394a90ad03a", "4526da60-c33b-fb4a-e063-6294a90a8692", "4526b265-4250-3e71-e063-6294a90a21a8", "2a92670f-80b4-abdb-e063-6294a90a6342", "4523713e-42b4-1ee9-e063-6394a90abb7d", "4526e2eb-ee8d-3ac4-e063-6394a90a133f", "4536cd82-d67c-56be-e063-6294a90a7775", "4526d753-7999-0ec3-e063-6294a90a270f", "453703bf-d4b7-d090-e063-6394a90a7ebf", "45371bc6-b83d-a96d-e063-6294a90a7c40", "45370735-3f9c-a7f8-e063-6294a90aa0c6" ], "spl_set_id": [ "b681ea25-d00b-4c8a-8054-cc6f983ce337", "19afd658-8c67-af44-e063-6394a90abada", "acf2d393-53d7-062f-e053-2995a90a0d60", "f0e77162-c601-1a0f-e053-2a95a90ab714", "ac32d6f9-f553-4d5c-ad36-575af5ea56de", "dc65f7ec-bb83-7b29-e053-2995a90a99de", "660ac9df-f1b1-4c89-94dd-9fae0a013f3c", "f3b9c643-a605-7702-e053-2995a90a6130", "37732ca2-b454-4215-91a2-c62e0f7a56af", "7dc04b48-f053-4e4b-a493-9e8286d2a791", "20938e05-bc3e-51aa-e054-00144ff88e88" ], "package_ndc": [ "11523-7157-2", "11523-7157-3", "11523-7157-4", "11523-7157-7", "11523-7157-8", "11523-7157-9", "11523-4329-1", "11523-4329-2", "11523-0101-1", "11523-0101-2", "11523-0101-3", "11523-0007-1", "11523-0007-2", "11523-0007-3", "11523-0007-7", "11523-0007-4", "11523-0007-5", "11523-0007-8", "11523-0007-9", "11523-0007-6", "66715-9742-1", "66715-9742-2", "11523-6655-1", "11523-6655-2", "11523-6655-3", "11523-6655-4", "11523-6655-6", "11523-6655-7", "11523-6655-9", "11523-6655-8", "11523-6655-5", "11523-0800-1", "11523-0800-2", "11523-7237-1", "11523-7237-3", "11523-7237-5", "11523-7237-6", "11523-7237-7", "11523-7237-8", "11523-7237-9", "11523-7160-1", "11523-7160-2", "11523-7160-3", "11523-7160-5", "11523-7160-6", "11523-7160-7", "11523-7160-9", "11523-7160-8", "11523-1527-1", "11523-1527-2", "11523-4359-1", "11523-4359-2", "11523-4359-3", "11523-4359-4", "11523-4359-5", "11523-4359-6", "11523-4359-8", "11523-4359-9", "11523-4359-7", "11523-0104-1", "11523-0104-2", "11523-0104-3", "11523-0104-4", "11523-0104-5", "11523-0104-6", "11523-4328-1", "11523-4328-2", "11523-4328-3", "11523-4328-5", "11523-4328-4", "11523-4328-7", "11523-4328-9", "11523-4328-6", "11523-4331-1", "11523-4331-2", "11523-4331-6", "11523-7202-1", "11523-7202-3", "11523-4330-1", "11523-4330-3", "11523-4330-4" ], "unii": [ "7AJO3BO7QN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LORAZEPAM 0.5MG", "activesubstance": { "activesubstancename": "LORAZEPAM" } }, { "drugcharacterization": "2", "medicinalproduct": "MIRALAX", "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "openfda": { "application_number": [ "NDA022015" ], "brand_name": [ "MIRALAX" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "11523-4357", "11523-7268", "11523-7234", "11523-7341" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193", "876195" ], "spl_id": [ "51040c1b-71bf-bb83-e063-6294a90aca4e" ], "spl_set_id": [ "d69ce3d4-7ca4-4fe3-b49e-6655e48d6963" ], "package_ndc": [ "11523-7268-3", "11523-7268-8", "11523-7268-7", "11523-7268-4", "11523-7268-9", "11523-7268-5", "11523-7234-1", "11523-7234-2", "11523-7234-3", "11523-7234-4", "11523-7234-5", "11523-7234-6", "11523-7234-9", "11523-7341-1", "11523-7341-2", "11523-4357-1", "11523-4357-3", "11523-4357-5", "11523-4357-2" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20190715" } } } ] }