{ "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": "12907043", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20170207", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20161103", "receiptdateformat": "102", "receiptdate": "20161103", "fulfillexpeditecriteria": "2", "companynumb": "US-CELGENEUS-USA-2016108239", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-USA-2016108239" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "19.1", "reactionmeddrapt": "Chromaturia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REVLIMID", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "021880", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MILLIGRAM", "drugdosageform": "CAPSULES", "drugadministrationroute": "048", "drugindication": "LYMPHADENOPATHY", "drugstartdateformat": "102", "drugstartdate": "20160912", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "openfda": { "application_number": [ "NDA021880" ], "brand_name": [ "REVLIMID" ], "generic_name": [ "LENALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-402", "59572-405", "59572-410", "59572-415", "59572-420", "59572-425" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], 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"activesubstancename": "CINNAMON" }, "openfda": { "brand_name": [ "CINNAMOMUM" ], "generic_name": [ "CINNAMON" ], "manufacturer_name": [ "Boiron" ], "product_ndc": [ "0220-1406", "0220-1343" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CINNAMON" ], "spl_id": [ "09bf3adf-99fc-6e40-e063-6394a90a1f45", "163b7c61-4581-0ff7-e063-6294a90a3689" ], "spl_set_id": [ "87353a5e-e8a4-d35e-e053-2991aa0ae0b0", "163b7c61-4580-0ff7-e063-6294a90a3689" ], "package_ndc": [ "0220-1406-41", "0220-1343-41" ], "nui": [ "N0000185371", "N0000175629", "N0000184306", "M0006342", "M0008672", "M0000728" ], "pharm_class_epc": [ "Non-Standardized Food Allergenic Extract [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]" ], "pharm_class_cs": [ "Dietary Proteins [CS]", "Food Additives [CS]", "Allergens [CS]" ], "unii": [ "5S29HWU6QB" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BUPROPION HCL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BUPROPION HYDROCHLORIDE" }, "openfda": {} }, { "drugcharacterization": "2", "medicinalproduct": "METOPROLOL TARTRATE.", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "METOPROLOL TARTRATE" }, "openfda": { "application_number": [ "ANDA204205", "ANDA077761", "ANDA078085", "NDA219373", "ANDA200981", "ANDA077739", "ANDA078950", "ANDA091045", "ANDA202871", "NDA218698", "NDA017963", "ANDA076704" ], "brand_name": [ "METOPROLOL TARTRATE", "LOPRESSOR", "METOPROLOL" ], "generic_name": [ "METOPROLOL TARTRATE", "METOROPROLOL TARTRATE", "METOPROLOL" ], "manufacturer_name": [ "Almaject, Inc.", "Hikma Pharmaceuticals USA Inc.", "Hospira, Inc.", "VALIDUS PHARMACEUTICALS LLC", "TRUPHARMA LLC", "Exelan Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", 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"76282-796-10", "59651-758-01", "59651-760-01", "72266-122-01", "72266-122-10", "72266-122-25", "57237-100-01", "57237-100-99", "57237-101-01", "57237-101-99", "57237-102-01", "57237-102-99", "36000-033-10", "72888-004-01", "72888-004-05", "72888-004-00", "72888-101-01", "72888-101-05", "72888-005-01", "72888-005-05", "72888-005-00", "72888-023-01", "72888-023-05", "72888-006-01", "72888-006-05", "72888-006-00", "63323-660-01", "63323-660-05", "62332-112-30", "62332-112-31", "62332-112-91", "62332-113-30", "62332-113-31", "62332-113-91", "62332-114-30", "62332-114-31", "62332-114-91", "65219-665-01", "65219-665-05", "30698-460-03", "30698-460-01", "30698-460-10", "52817-362-10", "52817-362-00", "52817-359-10", "52817-359-50", "52817-361-10", "52817-361-00", "52817-360-10", "52817-360-00", "52817-358-10", "52817-358-50", "0409-1778-15", "0409-1778-05", "25021-303-05", "30698-458-01", "30698-459-01", "72888-197-30", "72888-197-03", "72888-197-00", "68083-131-01", "65862-062-01", "65862-062-99", "65862-063-60", "65862-063-01", "65862-063-99", "65862-064-60", "65862-064-01", "65862-064-99", "72572-420-01", "72572-420-10", "72888-208-01", "72888-208-05", "72888-208-00", "72888-208-02", "72888-209-01", "72888-209-05", "72888-210-01", "72888-210-05", "72888-210-00", "72888-210-02", "72888-211-01", "72888-211-05", "72888-212-01", "72888-212-05", "72888-212-00", "0378-0018-01", "0378-0018-05", "0378-4593-01", "0378-0032-01", "0378-0032-10", "0378-4594-01", "0378-0047-01", "0378-0047-10", "46708-290-30", "46708-290-31", "46708-290-91", "46708-290-10", "46708-290-71", "46708-291-30", "46708-291-31", "46708-291-91", "46708-291-10", "46708-292-30", "46708-292-31", "46708-292-91", "46708-292-10" ], "unii": [ "W5S57Y3A5L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PROLIA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "openfda": { "application_number": [ "BLA125320" ], "brand_name": [ "PROLIA" ], "generic_name": [ "DENOSUMAB" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-710" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "DENOSUMAB" ], "rxcui": [ "993452", "993456" ], "spl_id": [ "f7182c92-ea87-4fec-b8f1-d8860f872b60" ], "spl_set_id": [ "49e5afe9-a0c7-40c4-af9f-f287a80c5c88" ], "package_ndc": [ "55513-710-01", "55513-710-21" ], "nui": [ "N0000187055", "N0000187054" ], "pharm_class_epc": [ "RANK Ligand Inhibitor [EPC]" ], "pharm_class_moa": [ "RANK Ligand Blocking Activity [MoA]" ], "unii": [ "4EQZ6YO2HI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CHLORELLA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "OLOPATADINE HCL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "OLOPATADINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA213514", "ANDA203152", "ANDA209752" ], "brand_name": [ "OLOPATADINE HCL", "EYE ALLERGY ITCH RELIEF" ], "generic_name": [ "OLOPATADINE HYDROCHLORIDE", "OLOPATADINE HCL" ], "manufacturer_name": [ "Rugby Laboratories", "Sola Pharmaceuticals", "CARDINAL HEALTH 110, LLC. DBA LEADER" ], "product_ndc": [ "0536-1478", "70512-520", "70000-0053" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "OLOPATADINE HYDROCHLORIDE" ], "rxcui": [ "1601086", "1111339", "1111343" ], "spl_id": [ "abf48a68-28f8-d2eb-1a84-acf9159f2f2f", "45728450-eb13-7314-e063-6394a90ae6d1", "ece56087-7def-0eb9-13d3-b187763b7f7b" ], "spl_set_id": [ "edb068e2-1835-483e-e59c-bcbe13b66d76", "e314e745-1e83-a530-e053-2995a90a67b4", "135bb2de-b2c0-6f0c-6204-3acbb48dcfbd" ], "package_ndc": [ "0536-1478-23", "70512-520-05", "70000-0053-1" ], "unii": [ "2XG66W44KF" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2016" } } } ] }