{ "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": 81342 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10003312", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "2", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140417", "fulfillexpeditecriteria": "1", "companynumb": "PHEH2014US004847", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHEH2014US004847" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "43", "patientonsetageunit": "801", "patientweight": "41.8", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pneumonia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ILARIS", "drugauthorizationnumb": "125319", "drugstructuredosagenumb": "90", "drugstructuredosageunit": "003", "drugdosagetext": "90 MG, EVERY 8 WEEKS", "drugdosageform": "Powder for sol for inj", "drugadministrationroute": "058", "drugindication": "CRYOPYRIN ASSOCIATED PERIODIC SYNDROME", "drugstartdateformat": "102", "drugstartdate": "20130823", "drugenddateformat": "102", "drugenddate": "20131226", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "BLA125319" ], "brand_name": [ "ILARIS" ], "generic_name": [ "CANAKINUMAB" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0734" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "CANAKINUMAB" ], "rxcui": [ "1864324", "1864326" ], "spl_id": [ "45376297-5629-4f69-a583-48a97e905a82" ], "spl_set_id": [ "7d271f3b-e4f9-4d80-8dcf-28d49123f80e" ], "package_ndc": [ "0078-0734-61" ], "unii": [ "37CQ2C7X93" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ILARIS", "drugauthorizationnumb": "125319", "drugdosageform": "Powder for sol for inj", "drugindication": "FAMILIAL COLD AUTOINFLAMMATORY SYNDROME", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "BLA125319" ], "brand_name": [ "ILARIS" ], "generic_name": [ "CANAKINUMAB" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0734" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "CANAKINUMAB" ], "rxcui": [ "1864324", "1864326" ], "spl_id": [ "45376297-5629-4f69-a583-48a97e905a82" ], "spl_set_id": [ "7d271f3b-e4f9-4d80-8dcf-28d49123f80e" ], "package_ndc": [ "0078-0734-61" ], "unii": [ "37CQ2C7X93" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5 MG, BID", "drugadministrationroute": "048", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "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.", "Endo USA, Inc.", "Strides Pharma Science Limited", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Dr. Reddys Laboratories Inc.", "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", "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", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "e6628b5c-a3e4-462b-a01a-695ed8d3ab64", "675efef2-fa13-42d1-9460-d1e334f78a48", "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", "8a3eba28-c6c2-4937-a75f-dc4b737002cd", "373a92c5-ce0a-4d94-a75c-496751230950", "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", "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", "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": "RELPAX", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugdosagetext": "40 MG, PRN", "drugadministrationroute": "048", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA021016" ], "brand_name": [ "RELPAX" ], "generic_name": [ "ELETRIPTAN HYDROBROMIDE" ], "manufacturer_name": [ "ROERIG", "Viatris Specialty LLC" ], "product_ndc": [ "0049-2330", "0049-2340", "58151-367", "58151-368" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ELETRIPTAN HYDROBROMIDE" ], "rxcui": [ "359493", "359494", "404443", "404444" ], "spl_id": [ "f6f124bc-c3e3-4ab8-b081-51068ec75eb8", "ca50a848-b287-47b6-980b-5729d4582893" ], "spl_set_id": [ "85745375-fcb6-4edc-b6db-a77b4a5f3e8c", "2a501dbd-3ea8-47e4-9fcb-07035b8c8c9e" ], "package_ndc": [ "0049-2330-79", "0049-2330-45", "0049-2340-79", "0049-2340-45", "0049-2340-05", "58151-367-56", "58151-368-56", "58151-368-96" ], "unii": [ "M41W832TA3" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ULTRACET", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, PRN", "drugadministrationroute": "048", "actiondrug": "5", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "AMBIEN", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, PRN", "drugadministrationroute": "048", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA019908", "NDA021774" ], "brand_name": [ "AMBIEN", "AMBIEN CR" ], "generic_name": [ "ZOLPIDEM TARTRATE" ], "manufacturer_name": [ "Cosette Pharmaceuticals, Inc.", "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0713-5401", "0713-5421", "0713-5501", "0713-5521", "0024-5521", "0024-5501", "0024-5401", "0024-5421" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ZOLPIDEM TARTRATE" ], "rxcui": [ "854873", "854875", "854876", "854878", "854880", "854882", "854894", "854896" ], "spl_id": [ "2d934208-e709-2948-e063-6294a90aa9b6", "2d9350bd-56ea-7273-e063-6394a90a0e61", "3781baee-63d5-40a7-bc44-fc72d1adca32", "3d6feaca-4f30-4ca9-a9c8-d9038744fa2f" ], "spl_set_id": [ "747949c5-2c91-4909-8a07-71b6826f8e97", "2d934da3-bd77-4470-e063-6294a90a64f5", "404c858c-89ac-4c9d-8a96-8702a28e6e76", "c36cadf4-65a4-4466-b409-c82020b42452" ], "package_ndc": [ "0713-5401-01", "0713-5421-01", "0713-5521-01", "0713-5501-01", "0024-5501-31", "0024-5501-10", "0024-5521-31", "0024-5521-50", "0024-5521-10", "0024-5401-31", "0024-5421-31", "0024-5421-50" ], "unii": [ "WY6W63843K" ] } } ] } } ] }