{ "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": "16439989", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20190711", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20190617", "receiptdateformat": "102", "receiptdate": "20190617", "fulfillexpeditecriteria": "1", "companynumb": "CA-ELI_LILLY_AND_COMPANY-CA201906004412", "duplicate": "1", "reportduplicate": { "duplicatesource": "ELI LILLY AND CO", "duplicatenumb": "CA-ELI_LILLY_AND_COMPANY-CA201906004412" }, "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "50", "patientonsetageunit": "801", "patientweight": "79", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Cognitive disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Fibromyalgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Somatic symptom disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Sacroiliitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Mood altered", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "APO-GABAPENTIN", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "GABAPENTIN" } }, { "drugcharacterization": "1", "medicinalproduct": "ATIVAN", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "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": "1", "medicinalproduct": "AMITRIPTYLINE", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "AMITRIPTYLINE" } }, { "drugcharacterization": "1", "medicinalproduct": "PANTOPRAZOLE", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "PANTOPRAZOLE" }, "openfda": { "application_number": [ "ANDA202882", "ANDA205119", "ANDA077619" ], "brand_name": [ "PANTOPRAZOLE SODIUM", "PANTOPRAZOLE" ], "generic_name": [ "PANTOPRAZOLE" ], "manufacturer_name": [ "XLCare Pharmaceuticals Inc.", "Quallent Pharmaceuticals Health LLC", "Amneal Pharmaceuticals LLC", "Camber Pharmaceuticals, Inc.", "NorthStar RxLLC", "Dr.Reddy's Laboratories Limited" ], "product_ndc": [ "72865-229", "72865-230", "82009-010", "82009-011", "65162-636", "65162-637", "31722-712", "31722-713", "72603-177", "72603-178", "55111-332", "55111-333" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PANTOPRAZOLE SODIUM" ], "rxcui": [ "251872", "314200" ], "spl_id": [ "f26fc428-a419-1008-e053-2a95a90a83fc", "48430767-cec0-15e0-e063-6394a90ac032", "940df77d-5373-4196-946e-19271ac91087", "48f42a12-2eac-e5dd-e063-6294a90aa92d", "57338853-6995-de1e-62ca-be5505c8d656", "c0575fc6-20c4-12a6-10b7-1af65cac1ee0" ], "spl_set_id": [ "17468dbf-84b6-4c53-9ad5-341350d2cfab", "643eb498-d916-4fb7-9281-32895575ab36", "f3ded82a-cf0d-4844-944a-75f9f9215ff0", "9daa1483-5a36-44db-9e0d-904d100da262", "82f0103a-2b97-d210-6d7d-c627d60ad694", "564709e8-358f-c185-4ecb-b3849c3fe59c" ], "package_ndc": [ "72865-229-90", "72865-230-90", "72865-230-10", "82009-010-90", "82009-011-90", "82009-011-10", "65162-636-03", "65162-636-09", "65162-637-03", "65162-637-09", "65162-637-50", "65162-637-11", "31722-712-90", "31722-712-32", "31722-712-31", "31722-713-90", "31722-713-32", "31722-713-31", "31722-713-10", "72603-177-01", "72603-178-01", "55111-332-30", "55111-332-90", "55111-332-01", "55111-332-05", "55111-332-10", "55111-332-79", "55111-332-81", "55111-332-78", "55111-333-30", "55111-333-90", "55111-333-01", "55111-333-05", "55111-333-10", "55111-333-79", "55111-333-81", "55111-333-78" ], "unii": [ "6871619Q5X" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TRAMADOL.", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "TRAMADOL" } }, { "drugcharacterization": "1", "medicinalproduct": "ENBREL", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "56", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "56 MG, WEEKLY (1/W)", "drugadministrationroute": "058", "drugindication": "ANKYLOSING SPONDYLITIS", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "ETANERCEPT" }, "openfda": { "application_number": [ "BLA103795" ], "brand_name": [ "ENBREL" ], "generic_name": [ "ETANERCEPT" ], "manufacturer_name": [ "Immunex Corporation" ], "product_ndc": [ "58406-010", "58406-425", "58406-021", "58406-032", "58406-044", "58406-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ETANERCEPT" ], "rxcui": [ "253014", "261105", "727757", "802652", "809158", "809159", "1653223", "1653225", "2182338", "2182340", "2392140", "2392142" ], "spl_id": [ "de3ee3bd-0047-4365-a4c7-5786521a1649" ], "spl_set_id": [ "a002b40c-097d-47a5-957f-7a7b1807af7f" ], "package_ndc": [ "58406-425-41", "58406-425-34", "58406-424-01", "58406-910-01", "58406-021-01", "58406-021-04", "58406-021-96", "58406-032-01", "58406-032-04", "58406-032-96", "58406-032-90", "58406-010-01", "58406-010-04", "58406-010-96", "58406-044-01", "58406-044-04", "58406-044-96", "58406-044-24", "58406-044-90", "58406-055-01", "58406-055-04", "58406-055-96", "58406-055-90" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "OP401G7OJC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYMBALTA", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "021427", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "CAPSULE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "DULOXETINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA021427" ], "brand_name": [ "CYMBALTA" ], "generic_name": [ "DULOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3235", "0002-3240", "0002-3270" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DULOXETINE HYDROCHLORIDE" ], "rxcui": [ "596926", "596928", "596930", "596932", "596934", "615186" ], "spl_id": [ "aa5061b1-f237-425a-9d05-575c333dfd37" ], "spl_set_id": [ "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba" ], "package_ndc": [ "0002-3235-60", "0002-3240-30", "0002-3240-90", "0002-3270-30" ], "unii": [ "9044SC542W" ] } }, { "drugcharacterization": "1", "medicinalproduct": "APO QUININE", "drugbatchnumb": "UNK", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "CAPSULE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "QUININE" } }, { "drugcharacterization": "1", "medicinalproduct": "CESAMET", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "CAPSULE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "NABILONE" }, "openfda": { "application_number": [ "NDA018677" ], "brand_name": [ "CESAMET" ], "generic_name": [ "NABILONE" ], "manufacturer_name": [ "Bausch Health US LLC" ], "product_ndc": [ "0187-1231" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NABILONE" ], "rxcui": [ "104885", "311891" ], "spl_id": [ "c8ba6520-445a-4934-85f4-6f706cb21585" ], "spl_set_id": [ "83c7ac15-ece9-47de-b83c-d575544fa449" ], "package_ndc": [ "0187-1231-50" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "2N4O9L084N" ] } } ] } } ] }