{ "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": 53192 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10003620", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140408", "fulfillexpeditecriteria": "1", "companynumb": "PHEH2014US004964", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHEH2014US004964" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientweight": "83.9", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Malnutrition", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Multiple sclerosis", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Loss of consciousness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "SOLUMEDROL", "drugindication": "MULTIPLE SCLEROSIS", "actiondrug": "5", "drugrecurreadministration": "3" }, { "drugcharacterization": "1", "medicinalproduct": "GILENYA", "drugauthorizationnumb": "022527", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "0.5 MG, QD", "drugdosageform": "CAPSULE", "drugadministrationroute": "048", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20110101", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA022527" ], "brand_name": [ "GILENYA" ], "generic_name": [ "FINGOLIMOD HCL" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0607", "0078-0965" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FINGOLIMOD HYDROCHLORIDE" ], "rxcui": [ "1012895", "1012899", "2045491", "2045493" ], "spl_id": [ "7b0c88c7-0bb4-44a4-9855-3156bfc63a66" ], "spl_set_id": [ "cc9e1c8c-0e2b-44e2-878b-27057f786be9" ], "package_ndc": [ "0078-0607-15", "0078-0607-51", "0078-0607-89", "0078-0965-89" ], "unii": [ "G926EC510T" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METHOTREXATE", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "602", "drugstartdate": "2005", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health, Inc.", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "3a5966e9-256b-4595-b962-e00d07526623", "6743bd6d-9c6b-4f43-b444-8faa4b5d5221", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "aca00bb2-33db-4471-b932-8690641f48fd", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "5ee46726-0b80-4f5c-a79d-334d34298709", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "461e9d94-1451-904d-e063-6294a90a05f4", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "c21629c1-6adf-4f56-9a95-a7ec698a2e6f", "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "424d715c-25c3-6376-e063-6294a90a2ef4", "f8955339-3c07-40ab-a866-ac75398ad2d6", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BETASERON", "drugindication": "MULTIPLE SCLEROSIS", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "BLA103471" ], "brand_name": [ "BETASERON" ], "generic_name": [ "INTERFERON BETA-1B" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-524" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "198360", "207059" ], "spl_id": [ "4ebf941b-8ad4-4faa-83d6-550b526270e9" ], "spl_set_id": [ "66311f74-0472-4fa3-848a-06002ca0def5" ], "package_ndc": [ "50419-524-01", "50419-524-35", "50419-524-05", "50419-524-09", "50419-524-81" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COPAXONE", "drugindication": "MULTIPLE SCLEROSIS", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA020622" ], "brand_name": [ "COPAXONE" ], "generic_name": [ "GLATIRAMER ACETATE" ], "manufacturer_name": [ "Teva Neuroscience, Inc." ], "product_ndc": [ "68546-317", "68546-325" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "GLATIRAMER ACETATE" ], "rxcui": [ "1111641", "1111642", "1487361", "1487363" ], "spl_id": [ "5a691b1f-367f-4635-a7d6-0111361a2dbb" ], "spl_set_id": [ "aa88f583-4f5f-433b-80b4-1f4c9fb28357" ], "package_ndc": [ "68546-317-00", "68546-317-30", "68546-325-06", "68546-325-12" ], "unii": [ "5M691HL4BO" ] } } ] } } ] }