{ "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": "18792418", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20210419", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20210127", "receiptdateformat": "102", "receiptdate": "20210127", "fulfillexpeditecriteria": "1", "companynumb": "US-GW PHARMA-202101USGW00138", "duplicate": "1", "reportduplicate": { "duplicatesource": "GW PHARMA", "duplicatenumb": "US-GW PHARMA-202101USGW00138" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "23.1", "reactionmeddrapt": "Device lead damage", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "LEVETIRACETAM.", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "openfda": { "application_number": [ "ANDA217878", "ANDA205130", "NDA204417", "ANDA219562", "ANDA090515", "ANDA201157", "ANDA078904", "ANDA209781", "NDA021872", "ANDA091399", "ANDA078858", "ANDA078106", "ANDA078582", "ANDA079063", "ANDA203052", "ANDA078234", "ANDA078774", "ANDA215980", "ANDA206880", "ANDA090876", "ANDA090981", "ANDA078154", "ANDA090025", "ANDA215069", "ANDA091261", "ANDA202958", "ANDA207160", "ANDA202869", "ANDA213532", "ANDA076920", "NDA202543", "NDA207958", "ANDA090263", "ANDA208458", "ANDA091338", "ANDA212688", "ANDA208619", "ANDA078993", "ANDA090767", "ANDA079120", "ANDA090992", "ANDA209705", "ANDA214815", "NDA021505", "NDA021035", "ANDA211954", "ANDA209474", "ANDA216375", "ANDA091485", "ANDA214757", "ANDA091491", "ANDA079042", "ANDA203468", "NDA022285", "ANDA218080", "ANDA203308", "ANDA090079", "ANDA204312", "ANDA076919", "ANDA090261", "ANDA217059", "ANDA078976" ], "brand_name": [ "LEVETIRACETAM", "LEVETIRACETAM ER", "ELEPSIA XR 1000 MG", "ELEPSIA XR 1500 MG", "KEPPRA", "ROWEEPRA", "LEVETIRACETAM IN SODIUM CHLORIDE", "LEVETIRACETAM SOLUTION", "SPRITAM", "LEVETIRACETAM EXTENDED-RELEASE", "KEPPRA XR" ], "generic_name": [ "LEVETIRACETAM", "LEVETIRACETAM IN SODIUM CHLORIDE", "LEVETIRACETAM ORAL", "LEVETIRACETAM INJECTION" ], "manufacturer_name": [ "Granules Pharmaceuticals Inc.", "Westminster Pharmaceuticals, LLC", "TRIPOINT THERAPEUTICS, LLC", "Somerset Therapeutics, LLC", "NorthStar RxLLC", "Major Pharmaceuticals", "Dr. Reddy's Laboratories Limited", "Method Pharmaceuticals, LLC", "UCB, Inc.", "Lupin Pharmaceuticals, Inc.", "Torrent Pharmaceuticals Limited", "Prinston Pharmaceutical Inc.", "Patrin Pharma, Inc.", "Aurobindo Pharma Limited", "Camber Pharmaceuticals, Inc.", "Exelan Pharmaceuticals, Inc.", "Sun Pharmaceutical Industries, Inc.", "OWP Pharmaceuticals, Inc.", "Novadoz Pharmaceuticals LLC", "Solco Healthcare US, LLC", "Dr.Reddy's Laboratories Inc", "Natco Pharma USA LLC", "Fresenius Kabi USA, LLC", "Civica, Inc.", "NorthStar Rx LLC", "Caplin Steriles Limited", "ScieGen Pharmaceuticals, Inc.", "Sagent Pharmaceuticals", "BluePoint Laboratories", "Apotex Corp.", "Eugia US LLC", "Hospira, Inc.", "Nexus Pharmaceuticals LLC", "WG Critical Care, LLC", "Prasco Laboratories", "Chartwell RX, LLC", "Baxter Healthcare Corporation", "Gland Pharma Limited", "Aprecia Pharmaceuticals, LLC", "ScieGen Pharmaceuticals, Inc", "Chartwell Governmental & Specialty RX, LLC.", "Omnivium Pharmaceuticals LLC", "Hp Halden Pharma AS", "Precision Dose, Inc.", "XLCare Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC", "Bionpharma Inc.", "B. 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"62756-259-04", "62756-260-01", "62756-260-02", "62756-260-03", "62756-260-04", "62756-260-05", "76282-228-01", "76282-227-01", "76282-226-01", "29300-428-01", "29300-428-05", "29300-429-01", "29300-429-05", "29300-430-01", "29300-430-05", "68001-242-00", "68001-243-00", "68001-244-00", "68001-244-03", "69097-861-07", "69097-861-12", "68462-128-01", "68462-128-05", "68462-129-01", "68462-129-05", "68462-130-01", "68462-130-05" ], "nui": [ "N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503" ], "pharm_class_epc": [ "Anti-epileptic Agent [EPC]" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_cs": [ "Sulfonamides [CS]" ], "pharm_class_moa": [ "Carbonic Anhydrase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "459384H98V" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VIMPAT", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "LACOSAMIDE" }, "openfda": { "application_number": [ "NDA022254", "NDA022253", "NDA022255" ], "brand_name": [ "VIMPAT" ], "generic_name": [ "LACOSAMIDE" ], "manufacturer_name": [ "UCB, Inc." ], "product_ndc": [ "0131-1810", "0131-2477", "0131-2478", "0131-2479", "0131-2480", "0131-5410" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "LACOSAMIDE" ], "rxcui": [ "809974", "809984", "809987", "809990", "809992", "809994", "809996", "809998", "810000", "810002", "993856", "995156" ], "spl_id": [ "51a12988-3e4b-c52b-e063-6394a90a7415" ], "spl_set_id": [ "9e79b42c-38a3-4b2c-a196-a5a1948250e2" ], "package_ndc": [ "0131-2477-35", "0131-2477-60", "0131-2477-99", "0131-2478-35", "0131-2478-60", "0131-2478-99", "0131-2479-35", "0131-2479-60", "0131-2479-99", "0131-2480-35", "0131-2480-60", "0131-2480-99", "0131-1810-67", "0131-5410-70", "0131-5410-71", "0131-5410-72" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "563KS2PQY5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20201215" } } } ] }