{ "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": 58753 } }, "results": [ { "safetyreportversion": "5", "safetyreportid": "10205058", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140529", "receiptdateformat": "102", "receiptdate": "20140822", "fulfillexpeditecriteria": "1", "companynumb": "US-MILLENNIUM-2014MPI000649", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-MILLENNIUM-2014MPI000649" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "21", "patientonsetageunit": "801", "patientweight": "59", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Basal cell carcinoma", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Nausea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Dysuria", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "PROBIOTIC", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PROBIOTICS NOS" } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugindication": "COLITIS ULCERATIVE", "actiondrug": "4", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IMODIUM", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LOPERAMIDE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA075232", "NDA019487", "NDA021140" ], "brand_name": [ "IMODIUM A-D", "IMODIUM MULTI-SYMPTOM RELIEF" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE", "LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-317", "50580-134", "50580-338" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE", "DIMETHICONE" ], "rxcui": [ "978010", "978013", "1250685", "1250693", "978001", "1426827" ], "spl_id": [ "3f75a619-8881-0bb3-e063-6394a90a1bcc", "3f73b325-ad6b-8e65-e063-6394a90a361e", "490ec903-14a6-e576-e063-6294a90a6d13" ], "spl_set_id": [ "01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "76a976d5-8bee-4158-a94d-7fbfc5544fd4", "ecb91e47-2b0c-47c8-9256-4623d8bc825e" ], "package_ndc": [ "50580-317-01", "50580-317-03", "50580-317-04", "50580-317-05", "50580-317-06", "50580-317-12", "50580-134-04", "50580-134-44", "50580-134-08", "50580-338-12", "50580-338-18", "50580-338-42", "50580-338-30", "50580-338-60", "50580-338-61", "50580-338-64", "50580-338-06", "50580-338-07" ], "unii": [ "77TI35393C", "92RU3N3Y1O" ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "250", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "250 ML, MONTHLY, EVERY 28 DAYS", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CROHN^S DISEASE", "drugstartdateformat": "102", "drugstartdate": "20111107", "actiondrug": "4", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LACTAID", "drugdosageform": "TABLET", "drugindication": "PROPHYLAXIS", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LACTASE" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D /00107901/", "drugstructuredosagenumb": "50000", "drugstructuredosageunit": "025", "drugdosagetext": "50000 IU, UNK", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ERGOCALCIFEROL" } }, { "drugcharacterization": "2", "medicinalproduct": "MULTIVITAMIN /01229101/", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, UNK", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PYREXIA", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "openfda": { "application_number": [ "M012", "M013" ], "brand_name": [ "TYLENOL COLD PLUS HEAD CONGESTION SEVERE", "TYLENOL REGULAR STRENGTH", "TYLENOL EXTRA STRENGTH" ], "generic_name": [ "ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE", "ACETAMINOPHEN" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-566", "50580-495", "50580-458", "50580-496", "50580-475", "50580-451", "50580-590", "50580-692", "50580-488" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1243679", "209387", "313782", "198440", "209459" ], "spl_id": [ "21aceda5-2c34-23df-e063-6394a90acb09", "25b09044-067e-eb90-e063-6394a90a6d21", "49576408-6940-93c6-e063-6394a90a6fa8", "25b0f4f0-fcf1-b399-e063-6294a90a10a6", "398d8996-b523-a3cd-e063-6394a90ac2c8", "2d87c8e1-e743-56cc-e063-6394a90aac79", "22d94fd9-9488-a812-e063-6394a90a7ffc", "21c193b9-6b79-f35c-e063-6394a90adbfe", "4eda2608-4d48-1af0-e063-6294a90a2c72" ], "spl_set_id": [ "ce43e5c2-fe96-4462-882c-d7479318b33d", "de5c6654-56c5-40d3-a286-f04ed47ac7c8", "01f41fae-4abb-4b96-ab09-a7d3dfc286cd", "1622f694-4d63-4c56-8737-fae31f0ecfb7", "398d8996-b522-a3cd-e063-6394a90ac2c8", "bb6533e5-e6a9-488c-b8ab-a6a06e87ede9", "015a6179-bacb-452d-b594-4de628ddc11d", "dd87e342-b0cb-4111-9f15-415dbcda4b77", "1b164780-ec84-4187-8afa-6f8a0da550fc" ], "package_ndc": [ "50580-566-25", "50580-495-01", "50580-458-11", "50580-458-50", "50580-458-10", "50580-496-60", "50580-496-98", "50580-475-11", "50580-475-50", "50580-475-10", "50580-451-03", "50580-451-10", "50580-451-50", "50580-451-70", "50580-590-01", "50580-590-02", "50580-590-03", "50580-590-04", "50580-590-05", "50580-590-06", "50580-692-01", "50580-692-02", "50580-692-03", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "362O9ITL9D", "495W7451VQ", "04JA59TNSJ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LACTAID", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "ABDOMINAL PAIN", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LACTASE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201306" } } } ] }