{ "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": 75171 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10006678", "primarysourcecountry": "DK", "occurcountry": "DK", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "DK-PFIZER INC-2014070359", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "DK-PFIZER INC-2014070359" }, "primarysource": { "reportercountry": "DK", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "66", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Amoebic colitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Necrotising colitis", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "METHOTREXATE SODIUM", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "15 MG, WEEKLY", "drugindication": "PSORIATIC ARTHROPATHY", "actiondrug": "1", "openfda": { "application_number": [ "ANDA040263", "ANDA201749", "ANDA040266", "ANDA216453", "ANDA040054" ], "brand_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "generic_name": [ "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Fresenius Kabi USA, LLC", "Sun Pharmaceutical Industries, Inc.", "Elite Laboratories, Inc.", "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "63323-123", "47335-235", "63323-122", "64850-330", "0054-4550", "0054-8550" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRAVENOUS", "ORAL", "INTRATHECAL" ], "substance_name": [ "METHOTREXATE SODIUM" ], "rxcui": [ "1946772", "105585", "311625" ], "spl_id": [ "880c2caa-1b11-45ce-a54e-a3733da367f0", "aca00bb2-33db-4471-b932-8690641f48fd", "3d21237a-ef53-4592-bf06-0c739696203d", "3897a21b-1b7c-47e7-abc2-5aed62840a57", "e0c12c0f-ae9c-4d79-8c27-b2ce3861f918" ], "spl_set_id": [ "b585f621-f6c9-4735-ab61-bd1b401f3df0", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "89c05ea3-3be1-46dd-b112-29c436fd7289", "d71b1856-99d8-4a9e-9189-f87b6675f80a" ], "package_ndc": [ "63323-123-10", "47335-235-96", "47335-235-83", "63323-122-50", "64850-330-01", "0054-4550-25", "0054-4550-15", "0054-8550-25" ], "unii": [ "3IG1E710ZN" ] } }, { "drugcharacterization": "1", "medicinalproduct": "METHYLPREDNISOLONE", "drugauthorizationnumb": "011153", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, 2X/DAY", "drugadministrationroute": "042", "drugindication": "INFLAMMATORY BOWEL DISEASE", "actiondrug": "1", "openfda": { "application_number": [ "NDA011153", "ANDA204072", "ANDA040183", "ANDA206751", "ANDA212396", "ANDA207549", "ANDA209097" ], "brand_name": [ "MEDROL", "METHYLPREDNISOLONE", "METHYLPREDNISOLONE SODIUM SUCCINATE" ], "generic_name": [ "METHYLPREDNISOLONE" ], "manufacturer_name": [ "Pharmacia & Upjohn Company LLC", "Epic Pharma, LLC", "Endo USA, Inc.", "Mylan Pharmaceuticals Inc.", "Zydus Lifesciences Limited", "BluePoint Laboratories", "Tianjin Kingyork Pharmaceuticals Co., Ltd", "Tianjin Tianyao Pharmaceuticals Co., Ltd.", "Zydus Pharmaceuticals USA Inc.", "Amneal Pharmaceuticals LLC", "Chartwell RX, LLC" ], "product_ndc": [ "0009-0020", "0009-0049", "0009-0056", "0009-0022", "0009-0073", "0009-0176", "42806-400", "0603-4593", "59762-0049", "59762-4440", "59762-0050", "59762-0051", "70771-1348", "70771-1349", "70771-1350", "70771-1351", "68001-624", "82094-401", "82094-402", "82094-403", "82094-404", "82094-405", "57582-101", "68382-916", "68382-917", "68382-918", "68382-919", "70121-1000", "70121-1001", "62135-759", "62135-760", "62135-761", "62135-762", "62135-763" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "METHYLPREDNISOLONE", "METHYLPREDNISOLONE SODIUM SUCCINATE" ], "rxcui": [ "197969", "197971", "197973", "207136", "207137", "207138", "207141", "259966", "260330", "328161", "762675", "834023", "311659", "314099", "1357886", "1743704" ], "spl_id": [ "e4a8e5b4-af77-4eca-92de-cd0982969b82", "a7416892-37af-4d45-ab52-5e5700e6b3e5", "6b210f06-32c0-450a-ad2b-2d0827b06f7a", "757e97bc-e224-4e63-819b-2f3213428207", "99239c7c-b107-454a-8cee-9dd6cbd5647b", "46874f82-02c9-e346-e063-6294a90ace4d", "94c8ce6b-7622-4d1f-8b54-0ce959752ae5", "925bd0e3-3f69-411c-ad1e-7db010ec17be", "6cebff10-362f-41a7-8f66-3d9e878760fd", "3eb27de6-9e1c-4ef4-bb31-2458b9360582", "225669c1-9479-52eb-e063-6394a90a649b" ], "spl_set_id": [ "39d5270b-d957-4821-93d6-501b7b9f02d4", "b1908c2a-c596-4e2a-b2bd-0745d4fea31a", "c84cf5e6-746d-41fb-b3d8-2c0b8ba989af", "22dd75d6-f89a-44f7-8ca6-b64c4e9806dd", "fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee", "7092df48-4904-4047-9916-e585417a216f", "77a8d96c-37df-4f3a-9757-b2d4131ff82b", "e09eefd2-f423-40cb-87b6-3ee97e7f831b", "eaa9c932-c659-4ef6-bf5a-186545d87320", "e86fbda8-00e4-4d54-841a-59dea6c15e70", "bdd048bb-7e6c-45c7-b51a-075e83ca9f5b" ], "package_ndc": [ "0009-0049-02", "0009-0056-02", "0009-0056-04", "0009-0022-01", "0009-0073-01", "0009-0176-01", "0009-0020-01", "42806-400-01", "42806-400-21", "0603-4593-21", "0603-4593-15", "59762-4440-3", "59762-4440-2", "59762-0049-1", "59762-0050-1", "59762-0051-1", "70771-1348-1", "70771-1348-5", "70771-1348-3", "70771-1349-8", "70771-1349-1", "70771-1349-5", "70771-1349-2", "70771-1349-4", "70771-1350-7", "70771-1350-1", "70771-1350-5", "70771-1350-2", "70771-1350-4", "70771-1351-8", "70771-1351-1", "70771-1351-5", "70771-1351-2", "70771-1351-4", "68001-624-01", "82094-401-01", "82094-401-50", "82094-402-01", "82094-402-50", "82094-403-01", "82094-403-50", "82094-404-01", "82094-404-50", "82094-405-01", "82094-405-50", "57582-101-01", "57582-101-02", "68382-916-01", "68382-916-05", "68382-916-34", "68382-917-11", "68382-917-01", "68382-917-05", "68382-917-30", "68382-917-77", "68382-918-18", "68382-918-01", "68382-918-05", "68382-918-30", "68382-918-77", "68382-919-11", "68382-919-01", "68382-919-05", "68382-919-30", "68382-919-77", "70121-1000-1", "70121-1000-5", "70121-1001-1", "70121-1001-5", "62135-759-30", "62135-760-21", "62135-760-01", "62135-761-26", "62135-762-50", "62135-763-26" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "X4W7ZR7023", "LEC9GKY20K" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PREDNISOLONE", "drugstructuredosagenumb": "60", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MG, 1X/DAY", "drugindication": "INFLAMMATORY BOWEL DISEASE", "actiondrug": "1", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } } ] } } ] }