{ "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": [ { "safetyreportid": "7001144-0", "transmissiondateformat": "102", "transmissiondate": "20110219", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20100920", "receiptdateformat": "102", "receiptdate": "20100908", "fulfillexpeditecriteria": "1", "companynumb": "US-ROCHE-720500", "primarysource": { "reportercountry": "UNITED STATES", "qualification": "5" }, "sender": { "senderorganization": "FDA-Public Use" }, "receiver": null, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddrapt": "ASTHENIA" }, { "reactionmeddrapt": "COUGH" }, { "reactionmeddrapt": "DECREASED APPETITE" }, { "reactionmeddrapt": "DIARRHOEA" }, { "reactionmeddrapt": "DYSPEPSIA" }, { "reactionmeddrapt": "DYSPNOEA" }, { "reactionmeddrapt": "FATIGUE" }, { "reactionmeddrapt": "HYPERSOMNIA" }, { "reactionmeddrapt": "IMPAIRED HEALING" }, { "reactionmeddrapt": "NAUSEA" }, { "reactionmeddrapt": "ORAL MUCOSAL EXFOLIATION" }, { "reactionmeddrapt": "PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME" }, { "reactionmeddrapt": "SKIN ULCER HAEMORRHAGE" }, { "reactionmeddrapt": "STOMATITIS" }, { "reactionmeddrapt": "TACHYCARDIA" }, { "reactionmeddrapt": "VOMITING" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "XELODA", "drugauthorizationnumb": "020896", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA020896" ], "brand_name": [ "XELODA" ], "generic_name": [ "CAPECITABINE" ], "manufacturer_name": [ "H2-Pharma, LLC" ], "product_ndc": [ "61269-475", "61269-470" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CAPECITABINE" ], "rxcui": [ "200327", "200328", "213292", "213293" ], "spl_id": [ "32dd0155-c5cb-49c2-9b74-74f40df22df7" ], "spl_set_id": [ "e702d84d-7162-4751-bf37-d724cc7e45a5" ], "package_ndc": [ "61269-470-60", "61269-475-12" ], "nui": [ "N0000000233", "N0000175595" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_epc": [ "Nucleoside Metabolic Inhibitor [EPC]" ], "unii": [ "6804DJ8Z9U" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TYKERB", "drugadministrationroute": "048", "drugindication": "BREAST CANCER", "drugstartdateformat": "102", "drugstartdate": "20100628", "openfda": { "application_number": [ "NDA022059" ], "brand_name": [ "TYKERB" ], "generic_name": [ "LAPATINIB" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0671" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LAPATINIB DITOSYLATE" ], "rxcui": [ "672149", "672152" ], "spl_id": [ "940eccaf-92b4-4562-8579-24a53c1bc48d" ], "spl_set_id": [ "eee37f88-ec6a-4c30-b8aa-e2c71f93088c" ], "package_ndc": [ "0078-0671-19" ], "unii": [ "G873GX646R" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TYKERB", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20100812", "openfda": { "application_number": [ "NDA022059" ], "brand_name": [ "TYKERB" ], "generic_name": [ "LAPATINIB" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0671" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LAPATINIB DITOSYLATE" ], "rxcui": [ "672149", "672152" ], "spl_id": [ "940eccaf-92b4-4562-8579-24a53c1bc48d" ], "spl_set_id": [ "eee37f88-ec6a-4c30-b8aa-e2c71f93088c" ], "package_ndc": [ "0078-0671-19" ], "unii": [ "G873GX646R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VICODIN" }, { "drugcharacterization": "2", "medicinalproduct": "XANAX", "openfda": { "application_number": [ "NDA018276", "NDA021434" ], "brand_name": [ "XANAX", "XANAX XR" ], "generic_name": [ "ALPRAZOLAM" ], "manufacturer_name": [ "PHARMACIA & UPJOHN COMPANY LLC", "Viatris Specialty LLC" ], "product_ndc": [ "0009-0029", "0009-0055", "0009-0090", "0009-0094", "58151-505", "58151-503", "58151-504", "58151-506", "58151-452", "58151-453", "58151-454", "58151-455" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ALPRAZOLAM" ], "rxcui": [ "141927", "141928", "197321", "197322", "214003", "214004", "308047", "308048", "433798", "433799", "433800", "433801", "687022", "687023", "687024", "687025" ], "spl_id": [ "f5323eac-81d0-4096-ac15-2f25220c5c28", "7ceb0a8d-f766-4806-a289-652080edf4a3", "27062ff4-9ce3-4d8a-aeae-f4468efb623a" ], "spl_set_id": [ "388e249d-b9b6-44c3-9f8f-880eced0239f", "c8990714-c2f5-4b0c-9f1c-91d77156d962", "bb5cf72e-3a41-41a8-9a38-80f974eca33f" ], "package_ndc": [ "0009-0029-01", "0009-0029-46", "0009-0029-02", "0009-0029-14", "0009-0055-01", "0009-0055-46", "0009-0055-03", "0009-0055-15", "0009-0090-01", "0009-0090-04", "0009-0090-13", "0009-0094-01", "0009-0094-03", "58151-503-91", "58151-504-91", "58151-505-91", "58151-506-91", "58151-452-01", "58151-452-05", "58151-453-01", "58151-453-05", "58151-454-01", "58151-454-05", "58151-455-01" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "YU55MQ3IZY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATIVAN", "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": "2", "medicinalproduct": "FLEXERIL" }, { "drugcharacterization": "2", "medicinalproduct": "BENADRYL", "openfda": { "application_number": [ "M012" ], "brand_name": [ "BENADRYL" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc.", "Kenvue Brands LLC" ], "product_ndc": [ "66715-6406", "66715-9706", "66715-6506", "50580-370", "50580-226" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1049630", "1049632" ], "spl_id": [ "2783d396-2842-91e9-e063-6294a90a88fe", "21716a1f-3636-bdde-e063-6394a90aab01", "57a6b529-75db-f06e-e063-6294a90a7dd3" ], "spl_set_id": [ "de2a64ce-c169-4162-b79e-d3809bea2147", "2884d2dc-2d4a-4ca6-ab73-688a80b428eb", "702f9786-7ce9-43e4-921d-e1db09612127" ], "package_ndc": [ "66715-9706-1", "66715-9706-2", "66715-9706-3", "66715-6406-2", "66715-6406-7", "66715-6406-8", "66715-6506-2", "50580-370-01", "50580-226-50", "50580-226-51", "50580-226-53", "50580-226-54", "50580-226-62", "50580-226-52", "50580-226-56", "50580-226-20", "50580-226-70", "50580-226-12", "50580-226-33" ], "unii": [ "TC2D6JAD40" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MARINOL", "openfda": { "application_number": [ "NDA018651" ], "brand_name": [ "MARINOL" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "ThePharmaNetwork, LLC" ], "product_ndc": [ "53097-568", "53097-569", "53097-570", "53097-571", "53097-572", "53097-573" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "197634", "197635", "197636", "205641", "205642", "205645" ], "spl_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48" ], "spl_set_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68" ], "package_ndc": [ "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } } ] } } ] }