{ "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": 10, "total": 20582 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10004416", "primarysourcecountry": "BR", "occurcountry": "BR", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "BR-BAYER-2014-037796", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "BR-BAYER-2014-037796" }, "primarysource": { "reportercountry": "BR", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", 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Inhibitor [EPC]" ], "pharm_class_moa": [ "Protein Kinase Inhibitors [MoA]" ], "unii": [ "9ZOQ3TZI87" ] } } ] } }, { "safetyreportversion": "3", "safetyreportid": "10005295", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140702", "fulfillexpeditecriteria": "1", "companynumb": "JP-BAYER-2014-036511", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "JP-BAYER-2014-036511" }, "primarysource": { "reportercountry": "JP", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "74", "patientonsetageunit": "801", "patientagegroup": "6", "patientweight": "55.78", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Diabetes mellitus", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Interstitial lung disease", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NEXAVAR", "drugauthorizationnumb": "021923", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "12400", "drugcumulativedosageunit": "003", "drugdosagetext": "400 MG, QD", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "HEPATOCELLULAR CARCINOMA", "drugstartdateformat": "102", "drugstartdate": "20140212", "drugenddateformat": "102", "drugenddate": "20140502", "activesubstance": { "activesubstancename": "SORAFENIB" }, "openfda": { "application_number": [ "NDA021923" ], "brand_name": [ "NEXAVAR" ], "generic_name": [ "SORAFENIB" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-488", "50419-489" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SORAFENIB" ], "rxcui": [ "597747", "615979" ], "spl_id": [ "e597a26e-e04a-4f91-8c7c-a83243286396" ], "spl_set_id": [ "b50667e4-5ebc-4968-a646-d605058dbef0" ], "package_ndc": [ "50419-488-58", "50419-489-01" ], "nui": [ "N0000175605", "N0000175076" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Protein Kinase Inhibitors [MoA]" ], "unii": [ "9ZOQ3TZI87" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GASMOTIN", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "032", "drugdosagetext": "DAILY DOSE 3 DF", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "MOSAPRIDE CITRATE" } }, { "drugcharacterization": "2", "medicinalproduct": "MONILAC", "drugstructuredosagenumb": "60", "drugstructuredosageunit": "012", "drugdosagetext": "DAILY DOSE 60 ML", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "LACTULOSE" } }, { "drugcharacterization": "2", "medicinalproduct": "CALONAL", "drugstructuredosagenumb": "2460", "drugstructuredosageunit": "003", "drugdosagetext": "DAILY DOSE 2460 MG", "drugadministrationroute": "048", "drugindication": "PAIN MANAGEMENT", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" } }, { "drugcharacterization": "2", "medicinalproduct": "FENTANYL CITRATE.", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugdosagetext": "DAILY DOSE 2 MG", "drugdosageform": "TRANSDERMAL PATCH", "drugadministrationroute": "062", "drugindication": "PAIN MANAGEMENT", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "FENTANYL CITRATE" }, "openfda": { "application_number": [ "NDA019115", "NDA020747", "NDA019101", "ANDA212086", "ANDA210762" ], "brand_name": [ "FENTANYL CITRATE" ], "generic_name": [ "FENTANYL CITRATE" ], "manufacturer_name": [ "Hospira, Inc.", "Teva Pharmaceuticals USA, Inc.", "Hikma Pharmaceuticals USA Inc.", "Civica, Inc.", "Fresenius Kabi USA, LLC", "Phlow Corp." ], "product_ndc": [ "0409-9093", "0409-9094", "0093-7866", "0093-7865", "0093-7867", "0093-7868", "0093-7869", "0093-7870", "0641-6027", "0641-6024", "0641-6025", "0641-6028", "0641-6026", "0641-6029", "0641-6030", "0641-6247", "0641-6248", "0641-6249", "0641-6289", "0641-6290", "72572-170", "72572-171", "72572-172", "63323-808", "63323-810", "63323-806", "81565-205" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", 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"63323-808-01", "63323-808-11", "63323-810-00", "63323-810-20", "63323-806-11", "63323-806-01", "63323-806-12", "63323-806-02", "63323-806-13", "63323-806-05", "63323-806-14", "63323-806-20", "63323-806-50", "81565-205-01", "81565-205-02" ], "unii": [ "MUN5LYG46H" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SENNA", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "002", "drugdosagetext": "DAILY DOSE .5 G", "drugdosageform": "GRANULES", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "SENNA LEAF\\SENNOSIDES\\SENNOSIDES A AND B" }, "openfda": { "application_number": [ "M007", "505G(a)(3)", "M008" ], "brand_name": [ "SENNA", "SENNA TABS", "ONELAX SENNA" ], "generic_name": [ "SENNOSIDES 8.6 MG TABLETS", "SENNOSIDES", "SENNA LEAF", "SENNA" ], "manufacturer_name": [ "Aarkish Pharmaceuticals NJ Inc.", "American Health Packaging", "Family Dollar Services Inc", "Boiron", "H E B", "Patrin Pharma, Inc.", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "QUALITY CHOICE (Chain Drug Marketing Association)", "Pharbest Pharmaceuticals, Inc.", "Reliable 1 Laboratories LLC", "Major Pharmaceuticals", "Akron Pharma Inc.", "Rugby Laboratories", "AARNA USA INC.", "Rite Aid Corporation", "PAI Holdings, LLC dba PAI Pharma", "Walgreens" ], "product_ndc": [ "81005-101", "60687-851", "55319-298", "0220-4642", "37808-675", "39328-020", "39328-120", "39328-220", "0220-4643", "46122-702", "83324-004", "16103-363", "69618-069", "0904-7528", "37808-782", "71399-0027", "0536-1483", "82568-0006", "11822-0298", "0121-4967", "69618-064", "71399-1017", "82568-0024", "0363-8820" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SENNOSIDES", "SENNA LEAF", "SENNOSIDES A AND B" ], "rxcui": [ "312935", "702311" ], "spl_id": [ "56d3eab0-0040-da54-e063-6294a90a09e2", "4860231c-fcbe-78df-e063-6394a90a26b0", "127bd8dd-7c0b-48ca-9662-1c5a6138b376", "3c591996-cf43-f089-e063-6394a90aff49", "cde8b1e7-b335-4d27-98bd-7686c5d660d9", "b42865b6-223b-461b-aabd-ca548a0339fa", "3b8d8a9c-2bea-881c-e063-6294a90abd8e", "ecb36956-0a73-4225-9f0a-a5286f7c6ee2", "22d033e2-47a4-4667-98a1-1968050a535f", "61f99f78-d945-4004-a167-f3a80979f4a4", "2de53996-629d-7455-e063-6294a90a21e4", "77e88305-734a-4b15-bbfe-67a32f02c143", "ffd1f134-7073-471d-9655-fc41a2543490", "4227fa19-b935-0fbc-e063-6294a90ac342", "94ef8dee-13d8-44b1-9eaa-fce49ed0cea6", "364d4dfc-a08a-1a27-e063-6394a90ad77b", "a8902034-4df3-4582-a632-07b003d46a2c", "788bfeed-afae-42ae-a24b-0634f35f000b", "2bc82d20-1476-46c7-e063-6394a90a0d44", "35428dd1-59c5-58f3-e063-6394a90af628", "d1e612c9-ccc5-4e54-912f-fdcdf2120e66", "b3e7783e-7909-46e5-8601-2684995904f6" ], "spl_set_id": [ "564bc9a5-13b5-4cce-a349-6b2e122683ed", "e3cbb71b-b45c-4ce1-820b-959dde04360d", "7dbcf9f4-eb98-41d9-9c2c-55d9d26942cb", "80b365a8-2911-1144-e053-2a91aa0a8985", "d047e4e9-b8ac-498e-9fde-8af5d415edaa", "a9f1ef8d-8700-481f-a709-972bb9d27153", "3b8d8a9c-2be9-881c-e063-6294a90abd8e", "da4b5f33-aee7-4c21-acf2-98649ec8bbf3", "1959ef47-95c1-4234-9e1c-ad679b8dfb77", "b9f8ea59-932f-4827-a87c-b4aff909c43f", "c8aa7ae9-7d00-db7d-e053-2995a90ae72b", "cfb6bf89-c77e-4372-9bc9-44d6a659c955", "60de7967-279c-478c-b4dd-e3b283375025", "27fa8f54-ed84-4afd-8da3-8754da48643b", "41d53783-7ac2-411c-b9bf-afd87b3af30d", "364d4dfc-a089-1a27-e063-6394a90ad77b", "f3a0938e-dbdb-4988-aa1e-78564948d6a0", "7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed", "ae46a611-20f2-74c8-e053-2995a90a32ce", "55ce3969-d7a6-49c4-8c13-d95690efc1a6", "7ad21fb7-20eb-48d6-be15-450aa2ec97d3", "2875fe94-07a0-4e6e-b574-0d8d7cdf0a11" ], "package_ndc": [ "81005-101-30", "81005-101-10", "60687-851-40", "60687-851-46", "60687-851-77", "55319-298-12", "0220-4642-41", "37808-675-10", "39328-020-08", "39328-120-05", "39328-120-50", "39328-120-99", "39328-220-15", "39328-220-50", "0220-4643-41", "46122-702-78", "83324-004-01", "16103-363-08", "16103-363-11", "69618-069-58", "0904-7528-41", "0904-7528-94", "37808-782-10", "71399-0027-8", "0536-1483-59", "82568-0006-1", "82568-0006-2", "82568-0006-3", "11822-0298-2", "11822-0298-6", "11822-0298-4", "0121-4967-05", "0121-4967-40", "69618-064-01", "71399-1017-1", "71399-1017-2", "71399-1017-3", "82568-0024-8", "0363-8820-50", "0363-8820-10", "0363-8820-30" ], "unii": [ "3FYP5M0IJX", "AK7JF626KX", "1B5FPI42EN" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JANUVIA", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugdosagetext": "50 MG DAILY", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2014", "drugenddateformat": "102", "drugenddate": "20140507", "activesubstance": { "activesubstancename": "SITAGLIPTIN PHOSPHATE" }, "openfda": { "application_number": [ "NDA021995" ], "brand_name": [ "JANUVIA" ], "generic_name": [ "SITAGLIPTIN" ], "manufacturer_name": [ "Merck Sharp & Dohme LLC" ], "product_ndc": [ "0006-0112", "0006-0221", "0006-0277" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SITAGLIPTIN PHOSPHATE" ], "rxcui": [ "665036", "665040", "665044", "2709603", "2709608", "2709612" ], "spl_id": [ "71d449de-955b-4711-9a44-1e1f66e2e9eb" ], "spl_set_id": [ "f85a48d0-0407-4c50-b0fa-7673a160bf01" ], "package_ndc": [ "0006-0221-01", "0006-0221-28", "0006-0221-31", "0006-0221-54", "0006-0112-01", "0006-0112-28", "0006-0112-31", "0006-0112-54", "0006-0277-01", "0006-0277-28", "0006-0277-31", "0006-0277-54", "0006-0277-02", "0006-0277-33", "0006-0277-82", "0006-0277-14", "0006-0277-27", "0006-0277-30" ], "unii": [ "TS63EW8X6F" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MAGMITT", "drugstructuredosagenumb": "1980", "drugstructuredosageunit": "003", "drugdosagetext": "DAILY DOSE 1980 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "610", "drugstartdate": "201401", "activesubstance": { "activesubstancename": "MAGNESIUM OXIDE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140307" } } }, { "safetyreportversion": "1", "safetyreportid": "10005418", "primarysourcecountry": "IT", "occurcountry": "IT", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "IT-GILEAD-2014-0096103", "duplicate": "1", "reportduplicate": { "duplicatesource": "GILEAD", "duplicatenumb": "IT-GILEAD-2014-0096103" }, "primarysource": { "reportercountry": "IT", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "35", "patientonsetageunit": "801", "patientsex": "0", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug interaction", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hepatotoxicity", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TRUVADA", "drugauthorizationnumb": "021752", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "HIV INFECTION", "actiondrug": "5", "openfda": { "application_number": [ "NDA021752" ], "brand_name": [ "TRUVADA" ], "generic_name": [ "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE" ], "manufacturer_name": [ "Gilead Sciences, Inc" ], "product_ndc": [ "61958-0701", "61958-0703", "61958-0704", "61958-0705" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMTRICITABINE", "TENOFOVIR DISOPROXIL FUMARATE" ], "rxcui": [ "476556", "639888", "1744001", "1744003", "1744005", 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Squibb & Sons, L.L.C.", "Camber Pharmaceuticals, Inc.", "Laurus Labs Limited", "Aurobindo Pharma Limited" ], "product_ndc": [ "0003-3622", "0003-3624", "0003-3631", "0003-3638", "31722-653", "31722-654", "31722-655", "42385-920", "42385-921", "42385-922", "65862-710", "65862-711", "65862-712", "65862-713" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATAZANAVIR SULFATE" ], "rxcui": [ "402093", "402094", "402246", "402247", "664741", "664743", "1598985", "1598989", "402245" ], "spl_id": [ "510c2d51-4943-401c-a008-ea22f61c6938", "30891c38-5d64-7df7-e063-6394a90ae762", "0e18774c-a32c-4961-9684-f5c6ffce64a1", "8f8c56e0-40ee-4643-88f7-d3571ff5a409" ], "spl_set_id": [ "165cff62-b284-4a27-a65d-9ec8a5bfcdd8", "8a0c609f-e296-4925-a35c-e93a04467655", "c98e40ec-8a2c-4f19-b1c3-c82f708c2490", "7fbea274-d6b5-4faa-bbf0-05fefab42114" ], "package_ndc": [ "0003-3624-12", "0003-3631-12", "0003-3622-12", "0003-3638-10", "31722-653-60", "31722-653-10", "31722-653-31", "31722-654-60", "31722-654-10", "31722-654-31", "31722-655-30", "31722-655-05", "31722-655-31", "42385-920-60", "42385-920-06", "42385-920-48", "42385-921-60", "42385-921-06", "42385-921-48", "42385-922-30", "42385-922-06", "42385-922-37", "65862-710-60", "65862-710-05", "65862-710-10", "65862-710-03", "65862-711-60", "65862-711-18", "65862-711-05", "65862-711-10", "65862-711-03", "65862-712-60", "65862-712-18", "65862-712-05", "65862-712-10", "65862-712-03", "65862-713-30", "65862-713-90", "65862-713-05", "65862-713-10", "65862-713-03" ], "unii": [ "4MT4VIE29P" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SORAFENIB", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "400 MG, QD", "drugadministrationroute": "065", "drugindication": "HEPATOCELLULAR CARCINOMA", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA021923", "ANDA209050", "ANDA209567", "ANDA207012", "ANDA216073", "ANDA217095" ], "brand_name": [ "NEXAVAR", "SORAFENIB", "SORAFENIB TOSYLATE" ], "generic_name": [ "SORAFENIB" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc.", "Yabao Pharmaceutical Co., Ltd. Beijing", "Teva Pharmaceuticals, Inc.", "Upsher-Smith Laboratories, LLC", "Mylan Pharmaceuticals Inc.", "Dr.Reddys Laboratories Inc", "Torrent Pharmaceuticals Limited" ], "product_ndc": [ "50419-488", "50419-489", "51990-201", "0480-5425", "24979-715", "0378-1201", "43598-458", "13668-682" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SORAFENIB", "SORAFENIB TOSYLATE" ], "rxcui": [ "597747", "615979" ], "spl_id": [ "e597a26e-e04a-4f91-8c7c-a83243286396", "533bf507-3ac8-7c25-e063-6294a90a7ff2", "213b5f06-be1f-4bc1-b09d-86c12f83d3b9", "55afb5e2-d3ae-6c46-e063-6394a90adec2", "40e1cce8-b7c1-4fad-8600-7d7b409bde7e", "b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925", "27389dc4-60cc-4c65-92e6-97bcc09f7d20" ], "spl_set_id": [ "b50667e4-5ebc-4968-a646-d605058dbef0", "06f442d6-071e-4081-b7f7-40f3b803ab3f", "dae598f7-823f-405c-ae31-f924594187b9", "68aa4b7f-3f13-4e73-b572-aa6c11a8429c", "b7919013-1511-44f0-a759-3fa78a9fa178", "93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6", "b5305e23-7bc6-44d8-b177-930c47d1653a" ], "package_ndc": [ "50419-488-58", "50419-489-01", "51990-201-06", "51990-201-12", "0480-5425-89", "24979-715-44", "24979-715-04", "0378-1201-78", "43598-458-04", "43598-458-36", "13668-682-30", "13668-682-60", "13668-682-12", "13668-682-74" ], "nui": [ "N0000175605", "N0000175076" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Protein Kinase Inhibitors [MoA]" ], "unii": [ "9ZOQ3TZI87", "5T62Q3B36J" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10011267", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20141201", "fulfillexpeditecriteria": "1", "companynumb": "JP-BAYER-2014-038756", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "JP-BAYER-2014-038756" }, "primarysource": { "reportercountry": "JP", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "79", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Hypoglycaemia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NEXAVAR", "drugauthorizationnumb": "021923", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "1600", "drugcumulativedosageunit": "003", "drugdosagetext": "400 MG, QD", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "HEPATOCELLULAR CARCINOMA", "drugstartdateformat": "102", "drugstartdate": "20140304", "drugenddateformat": "102", "drugenddate": "20140307", "actiondrug": "1", "activesubstance": { "activesubstancename": "SORAFENIB" }, "openfda": { "application_number": [ "NDA021923" ], "brand_name": [ "NEXAVAR" ], "generic_name": [ "SORAFENIB" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-488", "50419-489" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SORAFENIB" ], "rxcui": [ "597747", "615979" ], "spl_id": [ "e597a26e-e04a-4f91-8c7c-a83243286396" ], "spl_set_id": [ "b50667e4-5ebc-4968-a646-d605058dbef0" ], "package_ndc": [ "50419-488-58", "50419-489-01" ], "nui": [ "N0000175605", "N0000175076" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Protein Kinase Inhibitors [MoA]" ], "unii": [ "9ZOQ3TZI87" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140307" } } } ] }