{ "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": "8820938", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20130627", "reporttype": "2", "serious": "1", "seriousnessdeath": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20121002", "receiptdateformat": "102", "receiptdate": "20121002", "fulfillexpeditecriteria": "1", "companynumb": "CA-ROCHE-1136259", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROCHE", "duplicatenumb": "CA-ROCHE-1136259" }, "primarysource": { "reportercountry": "CA", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "59.02", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "16.0", "reactionmeddrapt": "Death", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MABTHERA", "drugauthorizationnumb": "103705", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugdosageform": "Infusion", "drugadministrationroute": "042", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20120131", "drugenddateformat": "102", "drugenddate": "20120829" }, { "drugcharacterization": "2", "medicinalproduct": "ARAVA", "openfda": { "application_number": [ "NDA020905" ], "brand_name": [ "ARAVA" ], "generic_name": [ "LEFLUNOMIDE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2160", "0088-2161", "0088-2162" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEFLUNOMIDE" ], "rxcui": [ "205284", "205285", "205286", "213377", "213379", "213380" ], "spl_id": [ "765327c7-cb5b-4637-84da-4fd9a024ad96" ], "spl_set_id": [ "320f63f2-fac3-4aee-aff8-85724e00ef52" ], "package_ndc": [ "0088-2160-30", "0088-2161-30", "0088-2162-33" ], "nui": [ "N0000175713" ], "pharm_class_epc": [ "Antirheumatic Agent [EPC]" ], "unii": [ "G162GK9U4W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE", "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA218035", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", "ANDA213386", "ANDA211575", "ANDA080356", "ANDA085162", "ANDA085161" ], "brand_name": [ "PREDNISONE", "PREDNISONE DELAYED RELEASE", "PREDNISONE TABLETS, USP, 5 MG", "PREDNISONE TABLETS, USP, 10 MG", "PREDNISONE TABLETS, USP, 20 MG" ], "generic_name": [ "PREDNISONE" ], "manufacturer_name": [ "ANI Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Par Health USA, LLC", "Strides Pharma Science Limited", "Dr. Reddys Laboratories Inc.", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Granulation Technology, Inc.", "Actavis Pharma, Inc." ], "product_ndc": [ "70954-056", "0378-0640", "0378-0641", "0378-0642", "0603-5335", "0603-5336", "0603-5337", "0603-5338", "0603-5339", "64380-782", "43598-888", "0054-9817", "0054-9828", "0054-9818", "62135-471", "59651-484", "74157-010", "74157-019", "0054-0017", "0054-4741", "0054-4742", "0054-4728", "0054-0018", "0054-0019", "0054-3722", "0054-3721", "0054-8739", "0054-8740", "0054-8724", "62135-553", "64380-783", "64380-835", "62135-470", "60219-1705", "60219-1706", "59651-485", "59651-486", "59651-487", "59651-488", "59651-489", "43598-886", "43598-887", "64380-784", "64380-785", "64380-949", "63561-0120", "63561-0121", "63561-0122", "60219-1707", "60219-1708", "70954-057", "70954-058", "70954-059", "70954-060", "70954-061", "0591-5052", "0591-5442", "0591-5443" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISONE" ], "rxcui": [ "198144", "198145", "312615", "312617", "198146", "763179", "763181", "763183", "763185", "1303135", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "68bdeba1-553d-4d18-ae66-5eb8a0a880b8", "675efef2-fa13-42d1-9460-d1e334f78a48", "1da2eb36-ff47-3cf6-e845-67460ced05fb", "249c4c6d-a058-489a-8f84-928c14bfd3f9", "45ae68aa-b969-3d1b-e063-6394a90a0a02", "6f9a9020-efd5-4f7d-90c7-11af33e93793", "463c5b39-7eb2-d396-e063-6394a90aa451", "523ad364-8d95-4679-9290-446d61f36eb5", "04b754a5-5740-f71c-e063-6294a90aef67", "c389b525-c68a-43dc-bacc-c75707b391b5", "45ae6dea-506e-55d8-e063-6394a90a0a4c", "abdf7308-9460-4e7f-a68a-2fe647e82602", "d957f055-4838-49e6-ae32-604fb3056bc4", "a9e0d98c-c1bf-62b0-67b3-3b8f8313b408", "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "3c696af0-7946-dd78-e063-6394a90a71cc", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "6e6cf2e7-c839-4c9f-a58a-fea5023fb432" ], "spl_set_id": [ "7335a293-992b-490c-ab8a-66a7ca1eea30", "fec09050-5ac2-451b-a2b9-5a21b2def212", "10fe5a3b-84dc-4600-87c2-b80c97ce18cf", "a2c2e8ee-d222-47c5-93c2-8b44160a7e48", "474974ac-9811-c9f5-4050-58e535351d00", "263ed4fa-3c29-4abb-9cb1-bc016bd34a05", "36631112-3abb-4003-886b-9fe6d9cbe2cc", "7b33767f-a520-4470-8f3f-4e86b38d615a", "463c7cd2-c973-5c6c-e063-6394a90a09a0", "3115aef0-fd50-4ec8-a064-3effb695f3f2", "92483276-d55c-42c6-8bbc-27137ff25296", "52010a34-aadb-4561-ac4a-3ee53f5e3566", "f532c919-765d-407a-9e01-db2dc0c006f5", "0740ef68-7641-432e-bd46-4710687fc9d7", "b1ac4c92-e1fd-4015-b172-0932790ae019", "01bdc479-1f1f-af94-837c-12e7e861321a", "2ef05381-faad-4e0f-b58d-9f2236a04a2c", "a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "03228706-92b9-43c9-8d73-c73aa124c58d", "f05eb734-07e7-491c-b2e9-aae340e03750", "aa0b1582-6ef3-4697-9ea6-5391e6e57853" ], "package_ndc": [ "70954-056-10", "70954-056-20", "0378-0640-01", "0378-0640-10", "0378-0641-01", "0378-0641-10", "0378-0642-01", "0378-0642-05", "0378-0642-10", "0603-5335-21", "0603-5335-32", "0603-5336-21", "0603-5337-21", "0603-5337-32", "0603-5337-15", "0603-5337-31", "0603-5338-21", "0603-5338-28", "0603-5338-32", "0603-5338-15", "0603-5338-31", "0603-5339-21", "0603-5339-28", "0603-5339-32", "64380-782-06", "43598-888-01", "43598-888-30", "0054-9828-25", "0054-9828-31", "0054-9817-25", "0054-9817-29", "0054-9818-25", "0054-9818-29", "62135-471-90", "62135-471-18", "59651-484-01", "59651-484-99", "59651-484-78", "74157-010-30", "74157-019-30", "0054-4741-25", "0054-4741-31", "0054-4742-25", "0054-4728-25", "0054-4728-31", "0054-0017-25", "0054-0017-29", "0054-0017-20", "0054-0018-25", "0054-0018-29", "0054-0018-20", "0054-0019-20", "0054-0019-25", "0054-3722-63", "0054-3722-50", "0054-3721-44", "0054-8739-25", "0054-8740-25", "0054-8724-25", "62135-553-30", "62135-553-90", "64380-835-01", "64380-835-06", "64380-783-06", "64380-783-08", "64380-783-01", "62135-470-90", "62135-470-18", "60219-1705-1", "60219-1706-1", "60219-1706-7", "60219-1706-2", "60219-1706-3", "59651-485-01", "59651-485-78", "59651-486-01", "59651-486-99", "59651-486-78", "59651-487-01", "59651-487-05", "59651-487-78", "59651-488-01", "59651-488-05", "59651-488-78", "59651-489-01", "59651-489-78", "43598-886-01", "43598-886-30", "43598-887-01", "43598-887-30", "64380-784-01", "64380-784-07", "64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RAMIPRIL", "openfda": { "application_number": [ "ANDA077626", "ANDA078832", "ANDA077900", "ANDA079116", "ANDA091604", "ANDA078745" ], "brand_name": [ "RAMIPRIL" ], "generic_name": [ "RAMIPRIL" ], "manufacturer_name": [ "Lupin Pharmaceuticals, Inc.", "Zydus Lifesciences Limited", "Hikma Pharmaceuticals USA Inc.", "Zydus Pharmaceuticals USA Inc.", "GSMS, Incorporated", "Rising Pharma Holdings, Inc.", "Exelan Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "BluePoint Laboratories", "Chartwell RX, LLC." ], "product_ndc": [ "68180-588", "68180-589", "68180-590", "68180-591", "65841-655", "65841-656", "65841-657", "65841-658", "0054-0106", "0054-0107", "0054-0108", "0054-0109", "68382-144", "68382-145", "68382-146", "68382-147", "51407-707", "51407-708", "51407-709", "57237-222", "57237-223", "57237-224", "57237-225", "76282-670", "76282-671", "76282-672", "76282-673", "65862-474", "65862-475", "65862-476", "65862-477", "68001-428", "68001-429", "68001-430", "68001-431", "62135-271", "62135-272", "62135-273", "62135-274" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RAMIPRIL" ], "rxcui": [ "198188", "198189", "261962", "845488" ], "spl_id": [ "43bbe4ee-f918-4087-93b9-336a801a8944", "1d7227b2-6052-40b4-bf22-29f18672ce08", "8a7f6a6e-70a7-43ce-9f85-e60e237246ba", "d155011e-1c8b-4ac2-9a2f-6d62127620c3", "9f641c30-6ffa-4765-8991-cc15976b111d", "a9af89b5-fbbe-4314-9f8d-f5a28a23b23e", "37481fc5-771f-4dc7-aa06-6913ab75d485", "5cc13f7e-66f9-463b-9f69-30445fa5c51b", "5aa8efd9-6e26-311d-e063-6394a90afe25", "47ce17ad-f085-8ce7-e063-6294a90a7520" ], "spl_set_id": [ "a8cdec12-81d1-4ef4-82c0-d05d93c37a07", "496b346b-ca79-4483-a950-bed9464e6a9d", "7e9e84f7-ff47-463d-bf47-7a9745960aae", "055bb582-67cd-425a-8823-d543c14305ce", "62f6aa5a-7587-4349-b61d-b2c235749979", "d5c58fb5-b415-4567-9790-55631705c5cd", "1e1dfacf-b831-4743-a874-9a5e5ef8a120", "d6d57158-e8f9-4c91-8317-0374e0c87d33", "45707435-4fc8-457e-9ff2-02d7be9b4a6e", "b7e49f05-6d4f-465a-b0d7-f704466a2e52" ], "package_ndc": [ "68180-589-09", "68180-589-10", "68180-589-01", "68180-589-02", "68180-590-09", "68180-590-10", "68180-590-01", "68180-590-02", "68180-591-09", "68180-591-10", "68180-591-02", "68180-591-01", "68180-588-01", "68180-588-02", "68180-588-09", "65841-655-06", "65841-655-16", "65841-655-01", "65841-655-05", "65841-655-30", "65841-656-06", "65841-656-16", "65841-656-01", "65841-656-05", "65841-656-30", "65841-657-06", "65841-657-16", "65841-657-01", "65841-657-05", "65841-657-30", "65841-658-06", "65841-658-16", "65841-658-01", "65841-658-05", "65841-658-30", "0054-0106-25", "0054-0107-29", "0054-0107-25", "0054-0107-20", "0054-0108-25", "0054-0108-29", "0054-0108-20", "0054-0109-25", "0054-0109-29", "68382-144-06", "68382-144-16", "68382-144-01", "68382-144-05", "68382-144-30", "68382-144-77", "68382-145-06", "68382-145-16", "68382-145-01", "68382-145-05", "68382-145-30", "68382-145-77", "68382-146-06", "68382-146-16", "68382-146-01", "68382-146-05", "68382-146-30", "68382-146-77", "68382-147-06", "68382-147-16", "68382-147-01", "68382-147-05", "68382-147-30", "68382-147-77", "51407-707-01", "51407-708-01", "51407-709-01", "57237-222-30", "57237-222-01", "57237-223-01", "57237-223-05", "57237-224-01", "57237-224-05", "57237-225-01", "57237-225-05", "76282-670-01", "76282-671-01", "76282-671-05", "76282-672-01", "76282-672-05", "76282-673-01", "76282-673-05", "65862-474-30", "65862-474-01", "65862-474-99", "65862-474-10", "65862-475-30", "65862-475-01", "65862-475-05", "65862-475-99", "65862-475-10", "65862-476-30", "65862-476-01", "65862-476-05", "65862-476-99", "65862-476-10", "65862-477-30", "65862-477-01", "65862-477-05", "65862-477-99", "65862-477-10", "68001-428-00", "68001-429-00", "68001-430-00", "68001-430-03", "68001-431-00", "68001-431-03", "62135-271-30", "62135-271-90", "62135-271-01", "62135-272-90", "62135-272-01", "62135-272-05", "62135-273-90", "62135-273-01", "62135-273-05", "62135-274-90", "62135-274-01", "62135-274-05" ], "nui": [ "N0000175562", "N0000000181" ], "pharm_class_epc": [ "Angiotensin Converting Enzyme Inhibitor [EPC]" ], "pharm_class_moa": [ "Angiotensin-converting Enzyme Inhibitors [MoA]" ], "unii": [ "L35JN3I7SJ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PERCOCET", "openfda": { "application_number": [ "ANDA040330" ], "brand_name": [ "PERCOCET" ], "generic_name": [ "OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN" ], "manufacturer_name": [ "SpecGx LLC" ], "product_ndc": [ "63481-623", "63481-627", "63481-628", "63481-629" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE", "ACETAMINOPHEN" ], "rxcui": [ "1049214", "1049221", "1049225", "1049625", "1049635", "1049637", "1049640", "1049642" ], "spl_id": [ "6195b18f-9786-4990-86ff-8a9aac83789a" ], "spl_set_id": [ "4dd36cf5-8f73-404a-8b1d-3bd53bd90c25" ], "package_ndc": [ "63481-627-70", "63481-623-70", "63481-623-85", "63481-628-70", "63481-629-70" ], "unii": [ "362O9ITL9D", "C1ENJ2TE6C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OXYCONTIN", "openfda": { "application_number": [ "NDA022272" ], "brand_name": [ "OXYCONTIN" ], "generic_name": [ "OXYCODONE HYDROCHLORIDE" ], "manufacturer_name": [ "Knoa Pharma LLC" ], "product_ndc": [ "59011-410", "59011-415", "59011-420", "59011-430", "59011-440", "59011-460", "59011-480" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE" ], "rxcui": [ "1049504", "1049545", "1049565", "1049576", "1049586", "1049595", "1049601", "1860127", "1860129", "1860137", "1860148", "1860151", "1860154", "1860157" ], "spl_id": [ "47b30347-ae1d-4b54-8ccd-594eb7bdbd75" ], "spl_set_id": [ "bfdfe235-d717-4855-a3c8-a13d26dadede" ], "package_ndc": [ "59011-410-10", "59011-410-20", "59011-415-10", "59011-415-20", "59011-420-10", "59011-420-20", "59011-430-10", "59011-430-20", "59011-440-10", "59011-440-20", "59011-460-10", "59011-460-20", "59011-480-20", "59011-480-10" ], "unii": [ "C1ENJ2TE6C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NORTRIPTYLINE" } ] } } ] }