{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 56834 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10005898", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "2014SP001388", "duplicate": "1", "reportduplicate": { "duplicatesource": "STRIDES", "duplicatenumb": "2014SP001388" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "69", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Angina pectoris", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": "091358", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "811", "drugindication": "RECTAL CANCER", "actiondrug": "1", "openfda": { "application_number": [ "ANDA207325", "ANDA217925", "ANDA203869", "ANDA207474", "ANDA204616", "ANDA217348", "ANDA204368", "ANDA078817", "ANDA078813", "ANDA219765", "ANDA091358", "NDA021759", "ANDA078811", "ANDA205529", "ANDA207385" ], "brand_name": [ "OXALIPLATIN" ], "generic_name": [ "OXALIPLATIN" ], "manufacturer_name": [ "Meitheal Pharmaceuticals Inc.", "FOSUN PHARMA USA INC.", "Gland Pharma Limited", "Camber Pharmaceuticals, Inc.", "Sagent Pharmaceuticals", "Accord Healthcare Inc.", "Qilu Pharmaceutical Co., Ltd.", "Sandoz Inc", "Hospira, Inc.", "Apotex Corp.", "Shandong New Time Pharmaceutical Co., Ltd.", "Mylan Institutional LLC", "BluePoint Laboratories", "Winthrop U.S, a business of sanofi-aventis U.S. LLC", "Fresenius Kabi USA, LLC", "Baxter Healthcare Corporation", "Northstar Rx LLC", "Eugia US LLC", "NorthStar Rx LLC" ], "product_ndc": [ "71288-149", "72266-161", "72266-162", "68083-176", "68083-177", "68083-314", "31722-357", "31722-358", "71288-101", "25021-233", "16729-332", "67184-0501", "67184-0502", "71288-171", "71288-172", "67184-0508", "67184-0509", "67184-0510", "0781-3315", "0781-3317", "61703-363", "60505-6132", "42677-336", "42677-337", "67457-442", "67457-469", "68001-468", "60505-6287", "0955-1731", "0955-1733", "63323-750", "43066-014", "43066-018", "72603-320", "72603-420", "55150-331", "55150-332", "72603-101", "72603-301", "68083-170", "68083-171", "0781-9315", "0781-9317" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "OXALIPLATIN" ], "rxcui": [ "1736776", "1736781", "1797528", "1736784", "1736786" ], "spl_id": [ "fb8d544c-a5df-4648-9422-9d53141d3a70", "2b48f7c2-8c48-6b82-e063-6394a90a3baf", "4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf", "3fee20f4-5fee-8b4e-e063-6294a90a1a0a", "d6861b65-5f18-4217-91b5-132425791d90", "c159050a-e588-4091-b9ee-ea502e1b9529", "0e2ec613-5375-858e-e063-6294a90ab95a", "f9f54aa0-22e3-4958-b368-d89d716ac2fa", "50b4c21f-714a-4a01-bf28-a856b19914d1", "e78605b3-b28b-4634-9a58-d4bda67832ba", "f3766495-fce3-461c-8c95-e890f5e3383f", "ecdfccf3-58e8-47ce-89d3-53a4d3e3af21", "3960461c-958a-43c1-a685-522039b021df", "4f6846af-385e-b624-e063-6394a90a28d7", "01a705c0-0014-4a63-aa66-918cdcc2df67", "a675c4d7-bb27-4a92-8b10-dbae3a4ceb2b", "2ee49254-54a3-0865-e063-6294a90a2974", "e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b", "0bef8406-8dab-0ad0-e063-6394a90a60d0", "504bf43e-4c28-4375-a6f4-285b2357f7f7", "e6815a98-0efc-4d69-8612-9e7ab7e78c0a", "9ebe158f-dd21-4bb8-ac13-d18162773cef", "faf81c5b-2d7e-4e6f-825b-f8a8399c0066", "f7b91231-4045-45a6-97c3-72fa9deaccf6", "0d039035-85d1-40d4-8ee6-540026ab7a5c", "ac83b4cd-5026-4dd5-b733-125d28ba3c95" ], "spl_set_id": [ "7e38318e-c569-4ad4-8f10-a235f30444d1", "fad0f147-6595-4412-87a7-2afca0192a96", "a6f89dc3-a594-4b5b-8728-272e20c1ecb5", "b0799e39-7b1e-430a-b159-062b39521001", "873fa936-157a-4f85-bc70-5df31d71d122", "29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f", "4b805925-beb1-2bac-e054-00144ff88e88", "e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64", "ee2e0da9-5ae7-405b-8dd1-635be72bc439", "33d4f4b4-bb4e-46af-9e89-df20154436d0", "ab162009-6f84-4d56-ab56-5e84409ec814", "e51a62ba-d163-4c57-835c-8c86cf097e40", "ee5a5a1d-63f6-4d5a-901b-65be45ec6610", "1ac38523-480b-4c0f-97a1-7dfa1432923c", "da0e8523-609a-4326-96b1-d7de78662d91", "11377169-7986-45b1-8298-6f0533efa3c3", "b6083405-9b45-4d2c-e053-2995a90ad9ef", "bb180ec5-1f75-43c1-9f63-c0657af2ca5f", "70269278-fe61-4800-a064-32cb6845cc28", "e12e2850-4980-48de-af58-15e559fb921f", "21a2bb1d-d91d-4f99-97dd-cc67fe99a090", "7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6", "1bb4febd-0ed4-48c9-ba2a-e22183a2143f", "f299b2d2-86ed-4fb8-822e-65455a0bb75a", "d6178bc6-9dae-413f-8f47-de75d576c5b8", "86f6c19d-30d1-42e3-8d46-5e3f45776e85" ], "package_ndc": [ "71288-149-95", "71288-149-96", "72266-161-01", "72266-162-01", "68083-176-01", "68083-177-01", "68083-314-01", "31722-357-10", "31722-358-20", "71288-101-10", "71288-101-20", "25021-233-10", "25021-233-20", "16729-332-03", "16729-332-05", "16729-332-35", "67184-0501-1", "67184-0502-1", "71288-171-11", "71288-172-21", "67184-0508-1", "67184-0509-1", "67184-0510-1", "0781-3315-70", "0781-3317-80", "61703-363-18", "61703-363-22", "60505-6132-6", "60505-6132-7", "60505-6132-8", "42677-337-01", "42677-337-10", "42677-336-01", "42677-336-10", "67457-469-10", "67457-442-20", "71288-171-91", "71288-172-92", "68001-468-36", "68001-468-37", "60505-6287-2", "60505-6287-4", "0955-1731-10", "0955-1733-20", "63323-750-10", "63323-750-20", "43066-014-01", "43066-018-01", "72603-420-01", "72603-320-01", "55150-331-01", "55150-332-01", "72603-301-01", "72603-101-01", "68083-170-01", "68083-171-01", "0781-9315-70", "0781-9317-80" ], "nui": [ "N0000175413", "N0000175073" ], "pharm_class_epc": [ "Platinum-based Drug [EPC]" ], "unii": [ "04ZR38536J" ] } }, { "drugcharacterization": "1", "medicinalproduct": "FOLINIC ACID", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "811", "drugindication": "RECTAL CANCER", "actiondrug": "1" }, { "drugcharacterization": "1", "medicinalproduct": "FLUOROURACIL", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "811", "drugindication": "RECTAL CANCER", "actiondrug": "1", "openfda": { "application_number": [ "NDA020985", "ANDA202668", "ANDA217676", "ANDA040278", "ANDA210124", "ANDA217295", "NDA016831", "ANDA210123", "ANDA215612", "ANDA076526", "ANDA203609", "ANDA040743", "ANDA040798", "NDA022259", "ANDA090368", "ANDA077524", "ANDA214845", "NDA220201", "ANDA216494", "ANDA040279", "ANDA216942", "ANDA215699", "ANDA202669" ], "brand_name": [ "FLUOROURACIL", "TOLAK", "EFUDEX", "FAVLYXA" ], "generic_name": [ "FLUOROURACIL CREAM, 0.5%", "FLUOROURACIL" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Inc.", "Eugia US LLC", "Alembic Pharmaceuticals Inc.", "Fresenius Kabi USA, LLC", "BluePoint Laboratories", "Mylan Pharmaceuticals Inc.", "Gland Pharma Limited", "Encube Ethicals, Inc.", "Taro Pharmaceuticals U.S.A., Inc.", "Sagent Pharmaceuticals", "Accord Healthcare, Inc.", "Xiromed LLC", "Alembic Pharmaceuticals Limited", "HILL DERMACEUTICALS, INC.", "Dr. Reddy's Labratories Inc.", "Accord Healthcare Inc.", "Bausch Health US, LLC", "Avyxa Pharma, LLC", "Mayne Pharma Inc.", "Meitheal Pharmaceuticals Inc.", "NORTHSTAR RX LLC" ], "product_ndc": [ "75907-169", "55150-496", "55150-497", "62332-779", "63323-117", "68001-525", "62332-751", "0378-4791", "68083-269", "68083-270", "21922-041", "51672-4062", "51672-4063", "25021-215", "16729-276", "70700-188", "70700-189", "70700-186", "70700-187", "46708-779", "28105-421", "51672-4118", "68001-524", "75907-095", "68001-628", "16729-542", "0187-3204", "0187-3202", "0187-3203", "83831-143", "51862-362", "46708-751", "68001-627", "71288-170", "21922-049", "71288-154", "55150-498", "55150-499", "68083-292", "68083-293", "16714-178" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "FLUOROURACIL" ], "rxcui": [ "284191", "1791701", "1791736", "239177", "310380", "310379", "1669868", "1669873", "105583", "213045", "2738666", "2738672" ], "spl_id": [ "39a2cbc0-f588-5397-e063-6394a90a5390", "7784c6bc-2624-42ba-a4ea-c63624eecec9", "15b365c5-47e3-4788-8df8-b0f6f323cd44", "7667002e-a888-47f5-8eec-519bfb2ebfb2", "e1f73bef-26d8-419c-96c1-a8f8aa201c63", "4bbe6cbf-4510-e811-e063-6294a90a0e28", "877caa50-ffd0-4c33-b61d-676c0b6ec82a", "1ff72539-1af5-41bf-8720-1ba12df35abc", "0e5faa31-6fd8-49b5-b838-1278cf068666", "f42c30f3-a83e-4721-8aa1-50d56cb13f4e", "3225bf24-833e-4d6a-bfe8-08df4fecb218", "223c5d8d-c064-4a0a-8490-b1c4aa0e706d", "4a675041-f691-5dcf-e063-6394a90a87c4", "4b35e0c2-3335-94bf-e063-6394a90a9454", "4b35b4f1-4de4-42de-e063-6294a90a10ae", "4a6723ea-dd4c-3f28-e063-6394a90a7378", "b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "db3a1489-fcb1-4442-b309-4eb8ad9b9f46", "170232f3-4992-1e1a-e063-6394a90a38e9", "4bbe764b-4bfd-3862-e063-6394a90a7cc0", "8ad197d1-c61c-41a1-bba4-ce5b7d1e8696", "984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3", "4e593090-faf2-cd72-e063-6294a90a2957", "23a8557b-45e6-e3cf-e063-6394a90a4b0d", "3375c5f7-9b6f-8ca1-e063-6394a90aaff8", "c8c3a5e0-277e-4d3e-910c-62cbc241cc3a", "d05a8a27-b7f9-40cc-a36a-97209fc998b1", "d10f12a2-7b38-4351-93df-1e8444d2a9e4", "4e58f3fc-4167-e42c-e063-6294a90a9fcb", "cb5958dc-12bd-4172-b45e-34b591eb316c", "0c579d19-82e7-4aac-bcb6-b3a60a3b48a3", "f33d88a4-f57f-45c7-8c13-94d69e4d7931", "d8218f3a-10d0-49d8-aa74-bae082019db2", "0097ac5b-1a37-46b0-8e5b-d8ae2311a25d", "692008d1-c9e5-40d2-a935-cd49e0cb95e5", "4680580c-772c-490d-bde9-c506c961e0b8", "d67aa3a4-76dd-496e-824f-c1a3ba0117a9", "7106b404-bb4d-43e4-9809-17bd2e95a63b" ], "spl_set_id": [ "37dcfb83-0e7d-d23d-9cd5-afa5bdc30628", "199ef964-8a9b-403e-a2ae-759280b3d1d1", "fdee9255-9447-4ae7-951d-b694802b5966", "21af1777-87f7-4e40-9917-f1677e7ff1a5", "beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff", "300304fa-4791-4455-962c-493ae467f504", "6b34cbf2-66f9-48a4-b41f-deb84ba8e8c4", "744737c5-0d96-4214-82ab-6cff016b1ea0", "572b710e-8e2b-46eb-bd80-648ad769d34d", "2c631ce7-ea15-4b51-b5bc-4962e3c315cd", "1b2f6145-b338-42ed-88a7-f4da65c59164", "37e35e8c-5d51-413b-a3a0-b72a18caaf65", "66d451fe-2436-494c-80c5-4528c8e34369", "f4b0cae1-a2fc-2991-d663-3b729503cd1c", "19735014-c6fb-0a05-c330-2e9389c71216", "8eff167f-203a-4a81-b2fc-d8773bc3555e", "b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "59de2709-00b8-4f0a-867c-f0dfeb947192", "acca0036-f19c-459b-9dfc-9592f1cd588d", "9c42eeff-ab0c-4820-94d7-e1a3df9fda74", "b4328ae3-f48f-40b1-9719-1c1aced7c734", "e137c766-1f7f-0251-90b9-450c3d4d78b9", "c612b05f-f37d-47fa-9c1e-b2d876dd7093", "667d4059-de90-4d3f-86c2-c2573def2ecb", "35de1c1c-bef5-46c5-b6f8-ea032147411c", "1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b", "06475bd8-66d9-4f88-90e4-b367480dab39", "d10f12a2-7b38-4351-93df-1e8444d2a9e4", "cdf07a8b-91ee-424f-8c04-34f53dfb82be", "a0cd6301-c6e0-4b62-8683-39c99913db24", "c45f5286-a52b-43e5-8a6f-d0312e7da0c8", "30294dd2-40fb-420d-b838-376343308895", "a85ab26a-05ea-498f-8f34-564a925fa9d9", "de8a3fce-85a9-4a77-a3cd-e50179b93098", "697816ce-dc05-4943-b7f0-2f0b125e93b7", "ea3497db-23b9-4ace-9a6f-b54853d04a82", "fdf2a165-2ca4-48be-89c1-570e6010b47c", "52ef5f41-2312-4b55-aa86-abd5bb28b9d3" ], "package_ndc": [ "75907-169-11", "55150-496-01", "55150-496-10", "55150-497-01", "55150-497-10", "62332-779-31", "63323-117-58", "63323-117-68", "63323-117-51", "63323-117-61", "68001-525-27", "68001-525-32", "62332-751-50", "0378-4791-06", "68083-269-01", "68083-269-10", "68083-270-01", "68083-270-10", "21922-041-12", "51672-4062-1", "51672-4063-1", "25021-215-98", "25021-215-99", "16729-276-03", "16729-276-68", "16729-276-05", "16729-276-67", "70700-188-22", "70700-189-22", "70700-187-22", "70700-187-23", "70700-186-22", "70700-186-23", "16729-276-11", "16729-276-38", "46708-779-31", "28105-421-40", "51672-4118-5", "51672-4118-2", "51672-4118-6", "68001-524-28", "68001-524-30", "68001-524-29", "68001-524-31", "63323-117-59", "63323-117-69", "75907-095-40", "68001-628-32", "16729-542-35", "0187-3202-10", "0187-3202-02", "0187-3203-10", "0187-3203-02", "0187-3204-47", "83831-143-01", "51862-362-40", "46708-751-50", "68001-627-27", "71288-170-75", "63323-117-00", "63323-117-10", "63323-117-01", "63323-117-20", "21922-049-17", "63323-117-43", "63323-117-18", "63323-117-41", "63323-117-28", "71288-154-76", "55150-498-01", "55150-499-01", "68083-292-01", "68083-293-01", "63323-117-31", "63323-117-19", "16714-178-01" ], "nui": [ "N0000000233", "N0000175595" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_epc": [ "Nucleoside Metabolic Inhibitor [EPC]" ], "unii": [ "U3P01618RT" ] } }, { "drugcharacterization": "1", "medicinalproduct": "BEVACIZUMAB", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "811", "drugindication": "RECTAL CANCER", "openfda": { "application_number": [ "BLA761198", "BLA125085" ], "brand_name": [ "AVZIVI TNJN", "AVASTIN" ], "generic_name": [ "BEVACIZUMAB" ], "manufacturer_name": [ "Bio-Thera Solutions, Ltd.", "Genentech, Inc." ], "product_ndc": [ "82143-001", "82143-002", "50242-060", "50242-061" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "BEVACIZUMAB-TNJN", "BEVACIZUMAB" ], "rxcui": [ "2700735", "2700742", "2700744", "2700745", "1657066", "1657068", "1657073", "1657074" ], "spl_id": [ "3fff12d3-d86b-14e4-e063-6294a90a122e", "8debebf6-af94-4ba7-8d67-c801f4ea27eb" ], "spl_set_id": [ "a3976cf9-9edb-4ca2-9375-9bcd2e32f5b4", "939b5d1f-9fb2-4499-80ef-0607aa6b114e" ], "package_ndc": [ "82143-001-01", "82143-002-01", "50242-060-01", "50242-060-10", "50242-061-01", "50242-061-10" ], "unii": [ "2S9ZZM9Q9V" ], "nui": [ "N0000193543", "N0000178291", "N0000193542" ], "pharm_class_epc": [ "Vascular Endothelial Growth Factor Inhibitor [EPC]" ], "pharm_class_moa": [ "Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]", "Vascular Endothelial Growth Factor Inhibitors [MoA]" ] } } ] } } ] }