{ "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. 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"Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10004679", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140723", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-21880-14030390", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-21880-14030390" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Non-Hodgkin^s lymphoma", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "XANAX", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "6", "drugintervaldosagedefinition": "805", "drugdosagetext": "2 MILLIGRAM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "048", "drugindication": "ANXIETY", "drugstartdateformat": "102", "drugstartdate": "20131220", "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "openfda": { "application_number": [ "NDA018276", "NDA021434" ], "brand_name": [ "XANAX", "XANAX XR" ], "generic_name": [ "ALPRAZOLAM" ], "manufacturer_name": [ "PHARMACIA & UPJOHN COMPANY LLC", "Viatris Specialty LLC" ], "product_ndc": [ "0009-0090", "0009-0029", "0009-0055", "0009-0094", "58151-503", "58151-504", "58151-505", 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"58151-455-01" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "YU55MQ3IZY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE.", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MILLIGRAM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "048", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20140113", "activesubstance": { "activesubstancename": "PREDNISONE" }, "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", 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"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": "MEGACE", "drugstructuredosagenumb": "800", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "800 MILLIGRAM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "048", "drugindication": "DECREASED APPETITE", "drugstartdateformat": "102", "drugstartdate": "20140102", "activesubstance": { "activesubstancename": "MEGESTROL ACETATE" } }, { "drugcharacterization": "2", "medicinalproduct": "MIRALAX", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "UNKNOWN", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "610", "drugstartdate": "201309", "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "openfda": { "application_number": [ "NDA022015" ], "brand_name": [ "MIRALAX" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "11523-4357", "11523-7268", "11523-7234", "11523-7341" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193", "876195" ], "spl_id": [ "51040c1b-71bf-bb83-e063-6294a90aca4e" ], "spl_set_id": [ "d69ce3d4-7ca4-4fe3-b49e-6655e48d6963" ], "package_ndc": [ "11523-7268-3", "11523-7268-8", "11523-7268-7", "11523-7268-4", "11523-7268-9", "11523-7268-5", "11523-7234-1", "11523-7234-2", "11523-7234-3", "11523-7234-4", "11523-7234-5", "11523-7234-6", "11523-7234-9", "11523-7341-1", "11523-7341-2", "11523-4357-1", "11523-4357-3", "11523-4357-5", "11523-4357-2" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REVLIMID", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugstartdateformat": "610", "drugstartdate": "201312", "drugrecurreadministration": "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" ], "route": [ "ORAL" ], "substance_name": [ "LENALIDOMIDE" ], "rxcui": [ "602910", "602912", "616114", "616116", "643712", "643714", "643720", "643722", "1242231", "1242233", "1428947", "1429367" ], "spl_id": [ "b5eadec8-aa2b-43ec-b0d6-e5b0c3da08cb" ], "spl_set_id": [ "5fa97bf5-28a2-48f1-8955-f56012d296be" ], "package_ndc": [ "59572-402-28", "59572-402-00", "59572-405-28", "59572-405-00", "59572-410-28", "59572-410-00", "59572-415-21", "59572-415-00", "59572-420-21", "59572-420-00", "59572-425-21", "59572-425-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "F0P408N6V4" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REVLIMID", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "021880", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosagetext": "25 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugindication": "NON-HODGKIN^S LYMPHOMA RECURRENT", "drugstartdateformat": "102", "drugstartdate": "20131202", "drugrecurreadministration": "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" ], "route": [ "ORAL" ], "substance_name": [ "LENALIDOMIDE" ], "rxcui": [ "602910", "602912", "616114", "616116", "643712", "643714", "643720", "643722", "1242231", "1242233", "1428947", "1429367" ], "spl_id": [ "b5eadec8-aa2b-43ec-b0d6-e5b0c3da08cb" ], "spl_set_id": [ "5fa97bf5-28a2-48f1-8955-f56012d296be" ], "package_ndc": [ "59572-402-28", "59572-402-00", "59572-405-28", "59572-405-00", "59572-410-28", "59572-410-00", "59572-415-21", "59572-415-00", "59572-420-21", "59572-420-00", "59572-425-21", "59572-425-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "F0P408N6V4" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140205" } } }, { "safetyreportversion": "2", "safetyreportid": "10004860", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140429", "fulfillexpeditecriteria": "2", "companynumb": "US-009507513-1403USA003786", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "US-009507513-1403USA003786" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "71", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Incorrect drug administration duration", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Therapeutic response changed", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Product odour abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": 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"Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CREON (PANCREATIN)", "drugdosagetext": "UNK, UNKNOWN", "drugindication": "PANCREATITIS CHRONIC", "actiondrug": "5", "drugrecurreadministration": "3" } ] } }, { "safetyreportversion": "2", "safetyreportid": "10005562", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140326", "fulfillexpeditecriteria": "2", "companynumb": "US-BIOGENIDEC-2014BI016864", "duplicate": "1", "reportduplicate": { "duplicatesource": "BIOGEN", "duplicatenumb": "US-BIOGENIDEC-2014BI016864" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "43", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hyperhidrosis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Insomnia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Flushing", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TECFIDERA", "drugauthorizationnumb": "204063", "drugstructuredosagenumb": "240", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "PROLONGED-RELEASE CAPSULE", "drugadministrationroute": "048", "drugindication": 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