{ "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": 10, "total": 85632 } }, "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" }, 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[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", 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"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" } } }, { "safetyreportversion": "2", "safetyreportid": "10239764", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140616", "receiptdateformat": "102", "receiptdate": "20140822", "fulfillexpeditecriteria": "1", "companynumb": "CA-TAKEDA-2014MPI001670", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "CA-TAKEDA-2014MPI001670" }, "primarysource": { "reportercountry": "CA", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "70", "patientonsetageunit": "801", "patientweight": "73.5", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Transitional cell carcinoma", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "SPIRIVA", "drugdosagetext": "2 PUFFS, PRN", "drugadministrationroute": "050", "drugindication": "CHRONIC OBSTRUCTIVE PULMONARY DISEASE", "drugstartdateformat": "602", "drugstartdate": "2009", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TIOTROPIUM BROMIDE MONOHYDRATE" }, "openfda": { "application_number": [ "NDA021395" ], "brand_name": [ "SPIRIVA HANDIHALER" ], "generic_name": [ "TIOTROPIUM BROMIDE" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0075" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "RESPIRATORY (INHALATION)" ], "substance_name": [ "TIOTROPIUM BROMIDE MONOHYDRATE" ], "rxcui": [ "485032", "580261" ], "spl_id": [ "94768574-0d3e-46f0-9f75-ab3c9f52857d" ], "spl_set_id": [ "820839ef-e53d-47e8-a3b9-d911ff92e6a9" ], "package_ndc": [ "0597-0075-41", "0597-0075-75", "0597-0075-47" ], "unii": [ "L64SXO195N" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BUDESONIDE.", 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"spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASA", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "81 MG, QD", "drugadministrationroute": "048", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "602", "drugstartdate": "2005", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ASPIRIN" } }, { "drugcharacterization": "2", "medicinalproduct": "GLUCOSAMINE", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "500 MG, TID", "drugadministrationroute": "048", "drugindication": "SUPPLEMENTATION THERAPY", "drugstartdateformat": "602", "drugstartdate": "2008", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "GLUCOSAMINE" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN C", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1000 MG, QD", "drugadministrationroute": "048", "drugindication": "SUPPLEMENTATION THERAPY", "drugstartdateformat": "602", "drugstartdate": "2005", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ASCORBIC ACID" }, "openfda": { "application_number": [ "M001" ], "brand_name": [ "VITAMIN C SERUM" ], "generic_name": [ "VITAMIN C" ], "manufacturer_name": [ "FlexiGo Inc" ], "product_ndc": [ "85524-2627" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "HYALURONIC ACID", "NIACINAMIDE", "ASCORBIC ACID" ], "spl_id": [ "496e7d41-2177-7b0c-e063-6394a90a98f1" ], "spl_set_id": [ "496e7d41-2176-7b0c-e063-6394a90a98f1" ], "package_ndc": [ "85524-2627-1", "85524-2627-2", "85524-2627-3", "85524-2627-4", "85524-2627-5", "85524-2627-6" ], "nui": [ "N0000193618", "M0001797" ], "pharm_class_epc": [ "Vitamin C [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]" ], "unii": [ "S270N0TRQY", "25X51I8RD4", "PQ6CK8PD0R" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140529" } } }, { "safetyreportversion": "5", "safetyreportid": "10294256", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20190711", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140710", "receiptdateformat": "102", "receiptdate": "20190527", "fulfillexpeditecriteria": "1", "companynumb": "US-UCBSA-2014004621", "duplicate": "1", "reportduplicate": { "duplicatesource": "UCB", "duplicatenumb": "US-UCBSA-2014004621" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "34", "patientonsetageunit": "801", "patientweight": "63.6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Stomatitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Rectal abscess", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "GATTEX", "drugstructuredosagenumb": ".32", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "0.32 MILLIGRAM, WEEKLY (QW)", "drugadministrationroute": "058", "drugindication": "DIARRHOEA", "drugstartdateformat": "102", "drugstartdate": "20130601", "actiondrug": "4", "activesubstance": { "activesubstancename": "TEDUGLUTIDE\\WATER" }, "openfda": { "application_number": [ "NDA203441" ], "brand_name": [ "GATTEX" ], "generic_name": [ "TEDUGLUTIDE" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "68875-0101", "68875-0103", "68875-0102" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "TEDUGLUTIDE" ], "rxcui": [ "1364472", "1364477", "1489307" ], "spl_id": [ "20ca0019-d3a4-4a8f-8dd4-67179d06e4dc" ], "spl_set_id": [ "66b69c1e-b25c-44d3-b5ff-1c1de9a516fa" ], "package_ndc": [ "68875-0101-1", "68875-0101-2", "68875-0103-1", "68875-0102-1" ], "nui": [ "N0000190992", "N0000190990", "N0000175140", "N0000175452" ], "pharm_class_epc": [ "GLP-2 Analog [EPC]" ], "pharm_class_moa": [ "Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 2 [Chemical/Ingredient]", "Analogs/Derivatives [Chemical/Ingredient]" ], "unii": [ "7M19191IKG" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IMODIUM", "drugdosagetext": "2 MG PRN", "drugadministrationroute": "048", "drugindication": "DIARRHOEA", "actiondrug": "4", "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": "2", "medicinalproduct": "RIFAXIMIN.", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "RIFAXIMIN" }, "openfda": { "application_number": [ "NDA021361" ], "brand_name": [ "XIFAXAN" ], "generic_name": [ "RIFAXIMIN" ], "manufacturer_name": [ "Salix Pharmaceuticals, Inc." ], "product_ndc": [ "65649-301", "65649-303" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIFAXIMIN" ], "rxcui": [ "429662", "539789", "856664", "856666" ], "spl_id": [ "b2e9bb84-e97e-4e7e-8a23-425418b4374d" ], "spl_set_id": [ "c5e8e2fd-7087-4b78-9181-cc259c0be2f1" ], "package_ndc": [ "65649-301-05", "65649-301-03", "65649-301-41", "65649-303-03", "65649-303-02", "65649-303-04", "65649-303-01", "65649-303-05" ], "nui": [ "N0000175500", "M0019113" ], "pharm_class_epc": [ "Rifamycin Antibacterial [EPC]" ], 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"0013-0102-20", "0013-0102-50", "0013-0102-60", "62135-960-01", "62135-960-05", "62135-960-10", "62135-960-31", "11534-201-01", "11534-201-07", "59762-5000-1", "59762-5000-2", "59762-5000-5", "59762-5000-6", "0093-3234-01", "0093-3234-05", "0093-3234-10", "11534-200-01", "11534-200-07", "11534-200-04", "59762-0104-1", "59762-0104-2", "59762-0104-5", "59762-0104-6", "16571-261-01", "16571-261-30", "0013-0101-01", "0013-0101-20", "0013-0101-10", "0013-0101-30" ], "nui": [ "N0000175781", "M0000971" ], "pharm_class_epc": [ "Aminosalicylate [EPC]" ], "pharm_class_cs": [ "Aminosalicylic Acids [CS]" ], "unii": [ "3XC8GUZ6CB" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140411" } } }, { "safetyreportversion": "1", "safetyreportid": "10313761", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140718", "receiptdateformat": "102", "receiptdate": "20140718", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014TUS006003", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014TUS006003" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "35", "patientonsetageunit": "801", "patientweight": "58.96", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Candida infection", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Mouth ulceration", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MG, UNK", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CROHN^S DISEASE", "drugstartdateformat": "102", "drugstartdate": "20140627", "actiondrug": "4", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "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": "PREDNISONE.", "drugadministrationroute": "048", "drugindication": "CROHN^S DISEASE", "actiondrug": "5", "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", "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.", "Par Health USA, LLC", "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", "0433f6e3-8d0e-41c4-a3e2-5ff3c555d57e", "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", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "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" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140701" } } }, { "safetyreportversion": "2", "safetyreportid": "10329750", "primarysourcecountry": "FR", "occurcountry": "FR", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnesslifethreatening": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140721", "receiptdateformat": "102", "receiptdate": "20140820", "fulfillexpeditecriteria": "1", "companynumb": "FR-TAKEDA-2014TEU005907", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "FR-TAKEDA-2014TEU005907" }, "primarysource": { "reportercountry": "FR", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "65", "patientonsetageunit": "801", "patientweight": "70", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Septic shock", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Large intestine perforation", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "LANTUS", "drugadministrationroute": "058", "drugindication": "DIABETES MELLITUS", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2220", "0088-2219" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CORTANCYL", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugdosagetext": "40 MG, UNK", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PREDNISONE" } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MG, UNK", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "ENTEROCOLITIS HAEMORRHAGIC", "drugstartdateformat": "102", "drugstartdate": "20140606", "drugenddateformat": "602", "drugenddate": "2014", "actiondrug": "1", "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": "NOVORAPID", "drugadministrationroute": "058", "drugindication": "DIABETES MELLITUS", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "INSULIN ASPART" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140616" } } }, { "safetyreportversion": "2", "safetyreportid": "10334727", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140723", "receiptdateformat": "102", "receiptdate": "20140912", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014TUS006437", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014TUS006437" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "50", "patientonsetageunit": "801", "patientweight": "88.89", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Bone pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Blindness unilateral", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Headache", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hypoaesthesia", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MG, 1 DOSE", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CROHN^S DISEASE", "drugstartdateformat": "102", "drugstartdate": "20140714", "drugenddateformat": "102", "drugenddate": "20140714", "actiondrug": "5", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], 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"58602-729-03" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FIORICET", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "6", "drugintervaldosagedefinition": "805", "drugdosagetext": "1 DF, Q6HR PRN", "drugadministrationroute": "048", "drugindication": "MIGRAINE", "drugstartdateformat": "102", "drugstartdate": "20140205", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\BUTALBITAL\\CAFFEINE" }, "openfda": { "application_number": [ "ANDA040885" ], "brand_name": [ "FIORICET" ], "generic_name": [ "BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE" ], "manufacturer_name": [ "Actavis Pharma, Inc." ], "product_ndc": [ "52544-080" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BUTALBITAL", "ACETAMINOPHEN", "CAFFEINE" ], "rxcui": [ "889520", "1432261" ], "spl_id": [ "b31b5178-c2d3-4d0c-9e68-95acc212a74a" ], "spl_set_id": [ "c018be7d-f7b8-45e2-97b8-8e7a71740657" ], "package_ndc": [ "52544-080-01" ], "nui": [ "N0000175693", "M0002177", "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_epc": [ "Barbiturate [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "pharm_class_cs": [ "Barbiturates [CS]", "Xanthines [CS]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "unii": [ "KHS0AZ4JVK", "362O9ITL9D", "3G6A5W338E" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201407" } } }, { "safetyreportversion": "2", "safetyreportid": "10348805", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140729", "receiptdateformat": "102", "receiptdate": "20140807", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014TUS006554", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014TUS006554" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "19", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Pseudomonas aeruginosa meningitis", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugdosagetext": "FIRST DOSE IN 250 ML NS BAG", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", 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"pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AZATHIOPRINE.", "actiondrug": "5", "activesubstance": { "activesubstancename": "AZATHIOPRINE" }, "openfda": { "application_number": [ "ANDA074069", "ANDA075252", "ANDA077621", "ANDA075568", "NDA016324", "ANDA208687" ], "brand_name": [ "AZATHIOPRINE", "AZASAN", "IMURAN" ], "generic_name": [ "AZATHIOPRINE" ], "manufacturer_name": [ "AvKARE", "Salix Pharmaceuticals", "Amneal Pharmaceuticals NY LLC", "Oceanside Pharmaceuticals", "Zydus Lifesciences Limited", "Zydus Pharmaceuticals USA Inc.", "Glenmark Pharmaceuticals, Inc", "Rising Pharma Holdings, Inc.", "Sebela Pharmaceuticals Inc.", "Ascend Laboratories, LLC" ], "product_ndc": [ "42291-071", "65649-231", "65649-241", "69238-1076", "68682-231", "68682-241", "65841-602", "68382-003", "68382-118", "68382-119", "68382-120", "60219-1076", "60219-2036", "60219-2037", "68462-502", "16571-835", 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"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": "IMURAN", "drugstructuredosagenumb": "150", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "150 MG, QD", "actiondrug": "5", "activesubstance": { "activesubstancename": "AZATHIOPRINE" }, "openfda": { "application_number": [ "NDA016324" ], "brand_name": [ "IMURAN" ], "generic_name": [ "AZATHIOPRINE" ], "manufacturer_name": [ "Sebela Pharmaceuticals Inc." ], "product_ndc": [ "54766-590" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AZATHIOPRINE" ], "rxcui": [ "105611", "197388" ], "spl_id": [ "431426e8-80d4-a4e2-e063-6394a90af918" ], "spl_set_id": [ "606101a0-6244-7eff-e053-2a91aa0acadd" ], "package_ndc": [ "54766-590-10" ], "nui": [ "N0000000233", "M0015066", "N0000175712", "M0018169" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_cs": [ "Nucleosides [CS]", "Purines [CS]" ], "pharm_class_epc": [ "Purine Antimetabolite [EPC]" ], "unii": [ "MRK240IY2L" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140714" } } }, { "safetyreportversion": "2", "safetyreportid": "10358410", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140801", "receiptdateformat": "102", "receiptdate": "20140808", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014MPI002050", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014MPI002050" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "54", "patientonsetageunit": "801", "patientweight": "100", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Transient ischaemic attack", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "LOSARTAN", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LOSARTAN" }, "openfda": { "application_number": [ "ANDA215959" ], "brand_name": [ "LOSARTAN POTASSIUM" ], "generic_name": [ "LOSARTAN" ], "manufacturer_name": [ "Granules Pharmaceuticals Inc.", "Granules India Ltd" ], "product_ndc": [ "70010-741", "70010-742", "70010-743", "62207-741", "62207-742", "62207-743" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOSARTAN POTASSIUM" ], "rxcui": [ "979480", "979485", "979492" ], "spl_id": [ "451da3de-077d-522d-e063-6394a90a3537", "39e0a359-f9d7-c3fb-e063-6394a90a86a8" ], "spl_set_id": [ "ca012edc-923d-4ada-a261-db82b71b3c4f", "f9953f51-f30a-952d-e053-6394a90abf5f" ], "package_ndc": [ "70010-741-03", "70010-741-09", "70010-741-10", "70010-742-03", "70010-742-09", "70010-742-10", "70010-743-03", "70010-743-09", "70010-743-10", "62207-741-54", "62207-741-49", "62207-742-54", "62207-742-49", "62207-743-54", "62207-743-49" ], "unii": [ "3ST302B24A" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PHENERGAN", "drugindication": "VOMITING", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PROMETHAZINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA083312" ], "brand_name": [ "PHENERGAN" ], "generic_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0641-6082", "0641-6083", "0641-6084", "0641-6085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "rxcui": [ "992460", "992462", "992858", "992876" ], "spl_id": [ "a64f0625-8d56-4994-8908-13614ca7b09f", "7d6e64fc-bbf2-4ea9-b866-8115c448e687" ], "spl_set_id": [ "6f7e47cc-f823-4336-8107-f980e3049617", "481866da-a712-48a5-853f-8e84aacaab6d" ], "package_ndc": [ "0641-6082-01", "0641-6082-25", "0641-6083-01", "0641-6083-25", "0641-6084-01", "0641-6084-25", "0641-6085-01", "0641-6085-25" ], "unii": [ "R61ZEH7I1I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GLUCOSE", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "002", "drugdosagetext": "15 G, PRN", "drugadministrationroute": "048", "drugindication": "BLOOD GLUCOSE DECREASED", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "DEXTROSE" } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugindication": "CROHN^S DISEASE", "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": "HUMALOG", "drugdosagetext": "2-12 UNITS, AC AND BEDTIME", "drugadministrationroute": "058", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "INSULIN LISPRO" }, "openfda": { "application_number": [ "BLA021017", "BLA020563", "BLA205747", "BLA021018" ], "brand_name": [ "HUMALOG MIX75/25 KWIKPEN", "HUMALOG MIX75/25", "HUMALOG", "HUMALOG KWIKPEN", "HUMALOG JUNIOR KWIKPEN", "HUMALOG TEMPO PEN", "HUMALOG MIX50/50 KWIKPEN" ], "generic_name": [ "INSULIN LISPRO" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-8797", "0002-7511", "0002-7510", "0002-7533", "0002-8799", "0002-7516", "0002-7714", "0002-8213", "0002-0800", "0002-7712", "0002-8208", "0002-8798", "0002-7512" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "INSULIN LISPRO" ], "rxcui": [ "259111", "752388", "847252", "847254", "242120", "865098", "1652239", "1652242", "1652639", "1652640", "1652644", "1652646", "1926331", "1926332", "2621571", "2621572", "260265", "731281", "847211", "847213" ], "spl_id": [ "e67019bc-6512-412d-9c1b-23f898c33f41", "d0a38a0f-9d29-44eb-bfd1-c83cbcba1008", "68646c94-50c7-4474-9301-250eb73e3aea" ], "spl_set_id": [ "c73da51a-1899-45ad-b6cf-9c52c36a25dd", "c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae" ], "package_ndc": [ "0002-7511-01", "0002-8797-01", "0002-8797-59", "0002-8797-61", "0002-7510-01", "0002-7510-17", "0002-7510-99", "0002-7533-01", "0002-8799-01", "0002-8799-59", "0002-8799-61", "0002-7516-01", "0002-7516-59", "0002-7516-99", "0002-7714-01", "0002-7714-59", "0002-7714-61", "0002-8213-01", "0002-8213-05", "0002-0800-01", "0002-7712-01", "0002-7712-27", "0002-7712-61", "0002-8208-01", "0002-8208-27", "0002-7512-01", "0002-7512-99", "0002-8798-01", "0002-8798-59", "0002-8798-99" ], "nui": [ "N0000004931", "N0000175453" ], "pharm_class_cs": [ "Insulin [Chemical/Ingredient]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "GFX7QIS1II", "059QF0KO0R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LANTUS", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "025", "drugdosagetext": "30 IU, BEDTIME", "drugadministrationroute": "058", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2220", "0088-2219" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SOTALOL.", "drugstructuredosagenumb": "120", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "120 MG, BID", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "SOTALOL" }, "openfda": { "application_number": [ "ANDA207428" ], "brand_name": [ "SOTALOL" ], "generic_name": [ "SOTALOL HYDROCHLORIDE" ], "manufacturer_name": [ "UNICHEM PHARMACEUTICALS (USA), INC." ], "product_ndc": [ "76385-114", "76385-125", "76385-115", "76385-126", "76385-116", "76385-127" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SOTALOL HYDROCHLORIDE" ], "rxcui": [ "1922720", "1922763", "1922765", "1923422", "1923424", "1923426" ], "spl_id": [ "96bb0a48-48ee-4756-959b-f901434fd629" ], "spl_set_id": [ "56879738-8662-4f5c-8386-761ab2b5e46f" ], "package_ndc": [ "76385-114-01", "76385-114-50", "76385-125-01", "76385-125-50", "76385-115-01", "76385-115-50", "76385-126-01", "76385-126-50", "76385-116-01", "76385-116-50", "76385-127-01", "76385-127-50" ], "unii": [ "HEC37C70XX" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PHENERGAN", "drugdosagetext": "12.5 MG, 0.5 ML PRN", "drugadministrationroute": "042", "drugindication": "NAUSEA", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PROMETHAZINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA083312" ], "brand_name": [ "PHENERGAN" ], "generic_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0641-6082", "0641-6083", "0641-6084", "0641-6085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "PROMETHAZINE HYDROCHLORIDE" ], "rxcui": [ "992460", "992462", "992858", "992876" ], "spl_id": [ "a64f0625-8d56-4994-8908-13614ca7b09f", "7d6e64fc-bbf2-4ea9-b866-8115c448e687" ], "spl_set_id": [ "6f7e47cc-f823-4336-8107-f980e3049617", "481866da-a712-48a5-853f-8e84aacaab6d" ], "package_ndc": [ "0641-6082-01", "0641-6082-25", "0641-6083-01", "0641-6083-25", "0641-6084-01", "0641-6084-25", "0641-6085-01", "0641-6085-25" ], "unii": [ "R61ZEH7I1I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN.", "drugstructuredosagenumb": "81", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "81 MG, QD", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ASPIRIN" }, "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC SAFETY COATED", "ASPIRIN DELAYED RELEASE", "GOOD NEIGHBOR PHARMACY ASPIRIN", "LEADER ASPIRIN", "CHEWABLE LOW DOSE ASPIRIN", "CIRCLE K ASPIRIN 325", "LOW DOSE ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 81MG ENTERIC COATED", "CHILDRENS ASPIRIN", "CVS EFFERVESCENT PAIN RELIEVER", "BASIC CARE ASPIRIN", "SIGNATURE SELECT EFFERVESCENT PAIN RELIEF", "TRI-BUFFERED ASPIRIN", "ASPIRIN ENTERIC COATED, REGULAR STRENGTH", "ASPIRIN LOW DOSE CHEWABLE", "ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 325 MG", "MEDIQUE AT HOME ASPIRIN", "REGULAR STRENGTH ENTERIC COATED ASPIRIN", "DYE-FREE ASPIRIN 81", "PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR", "BEST CHOICE EFFERVESCENT PAIN RELIEVER 36", "ASPIRIN 81 MG", "BAYER ASPIRIN ORIGINAL, TRAVEL BASIX", "BAYER ASPIRIN ORIGINAL, CVP HEALTH", "BAYER", "QUALITY CHOICE EFFERVESCENT PAIN RELIEF", "ASPI-COR", "UNISHIELD ASPIRIN", "FAMILY WELLNESS PAIN RELIEVER", "ASPIRINA CAPLETS", "ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN", "EQUATE ASPIRIN CHEWABLE", "GOOD SENSE ASPIRIN", "BAYER ASPIRIN REGIMEN ENTERIC COATED", "RUGBY ASPIRIN", "ASPIRIN NSAID", "RIGHT REMEDIES LOW DOSE ASPIRIN 81MG", "ASPIRIN 50 CT", "SUNMARK ASPIRIN", "ASPIRIN PAIN RELIEF", "DIRECT SAFETY ASPIRIN", "ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE", "FIRST AID DIRECT CHEWABLE ASPIRIN", "FOSTER AND THRIVE ASPIRIN", "ENTERIC COATED ASPIRIN REGULAR STRENGTH", "LIL DRUG STORE ASPIRIN 325", "DOLLAR GENERAL EFFERVESCENT PAIN RELIEVER", "ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN LOW DOSE CHEWABLE ORANGE", "ADULT LOW DOSE PAIN RELIEVER", "ASPIRIN PAIN RELIVER", "DG HEALTH ASPIRIN", "LOW DOSE CHEWABLE ASPIRIN", "ASPIRIN REGIMEN", "GREEN GUARD CHEWABLE ASPIRIN 81 MG", "ECOTRIN REGULAR STRENGTH", "GENCARE-ASPIRIN LOW DOSE PAIN RELIEVER (NSAID)", "ASPIRIN LOW DOSE ENTERIC COATED", "PHYSICIANS CARE ASPIRIN", "ASPIRIN 325", "BAYER LOW DOSE", "MARKET BASKET EFFERVESCENT PAIN RELIEF", "BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE", "WINCO FOODS EFFERVESCENT PAIN RELIEF", "MEIJER LOW DOSE ASPIRIN", "ASPIRIN LOW STRENGTH", "LOW STRENGTH CHEWABLE ASPIRIN", "MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN", "PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN 81MG ADULT LOW DOSE", "ECOTRIN", "EXTRA STRENGTH ASPIRIN", "LOW DOSE ASPIRIN 81MG", "NOBLEAID PAIN RELIEVER", "COATED ASPIRIN", "TOPCARE EFFERVESCENT PAIN RELIEF", "ASPIRIN 325 MG EC", "XPECT CHEWABLE ASPIRIN", "MCKESSON ASPIRIN", "GOOD SENSE EFFERVESCENT PAIN RELIEF", "MEIJER EFFERVESCENT PAIN RELIEF", "ASPIRIN CHEWABLE", "PAIN RELIEF ASPIRIN", "UP AND UP CHEWABLE ASPIRIN", "REGULAR STRENGTH ASPIRIN 325 MG", "ST. JOSEPH LOW DOSE ASPIRIN", "CARDIASPIRIN PROTECT", "ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN", "MEDIQUE PRODUCTS ASPIRIN", "MEDI-FIRST ASPIRIN", "MEDI-FIRST PLUS ASPIRIN", "EQUALINE EFFERVESCENT PAIN RELIEVER", "ASPIRIN ENTERIC COATED LOW DOSE", "ADULT LOW STRENGTH ASPIRIN", "THOMPSON ASPIRIN", "LOW DOSE ASPIRIUN", "ULINE ASPIRIN" ], "generic_name": [ "ASPIRIN", "ASPIRIN 81 MG", "ASPIRIN 325 MG" ], "manufacturer_name": [ "Unifirst First Aid Corporation", "Health Pharma USA LLC", "Topco Associates, LLC", "Walgreen Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Advanced Rx LLC", "H E B", "Chain Drug Marketing Association, Inc.", "Discount Drug Mart Inc", "STRATEGIC SOURCING SERVICES LLC", "L.N.K. International, Inc.", "Grocery Outlet", "Rising Pharma Holdings, Inc.", "HARRIS TEETER", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Trifecta Pharmaceuticals USA LLC", "Marc Glassman, Inc.", "Care One (Retail Business Services, LLC.)", "Geritrex LLC", "Cardinal Health 110, LLC. 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Perrigo Company", "Rugby Laboratories", "Gendose Pharmaceuticals, LLC", "Hy-Vee", "Reliable 1 Laboratories LLC", "TOP CARE (Topco Associates LLC)", "TIME CAP LABORATORIES, INC", "Strive Pharmaceuticals Inc.", "HyVee Inc", "Strategic Sourcing Services LLC", "BETTER LIVING BRANDS, LLC", "JHK Inc dba American Safety & First Aid", "Meijer", "Direct Safety", "Salado Sales, Inc.", "Cintas Corp", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services Inc", "Dolgencorp, Inc", "Pinnacle RX LLC", "GOODSENSE", "Health Pharma USA, LLC", "TWIN MED LLC", "Pioneer Life Sciences, LLC", "Meijer Distribution Inc", "Dolgencorp, LLC", "Marlex Pharmaceuticals Inc.", "Sam's West Inc", "WinCo Foods, LLC", "Unifirst First Aid Corporaiton", "Safeway", "Medtech Products Inc.", "Lodaat LLC", "Acme United Corporation", "McKesson Medical-Surgical, Inc.", "DEMOULAS SUPER MARKETS, INC.", "Winco Foods, LLC", "Meijer, Inc.", "Richmond Pharmaceuticals, Inc", "Famora Inc.", "PUBLIX SUPER MARKETS INC", "FSA STORE INC.", "Pharbest Pharmaceuticals, Inc.", "Discount Drug Mart", "Dr. Wayne's", "H-E-B", "TopCare", "HHH Pharmaceuticals", "Athlete's Needs Inc", "Noble Otc LLC", "TOPCO ASSOCIATES LLC", "Cintas Corporation", "McKesson Medical-Surgical", "AMERIFOODS TRADING COMPANY", "TIME CAP LABS INC", "Perrigo Direct, Inc.", "Walmart Inc.", "Target Corporation", "Kroger", "HEB", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "Foundation Consumer Healthcare", "Aarkish Pharmaceuticals NJ Inc.", "OPMX LLC", "Foundation Consumer Healthcare LLC", "INVAHEALTH INC", "UNITED NATURAL FOODS, INC. DBA UNFI", "NUVICARE LLC", "Thompson", "FSA Store Inc.", "ULINE", "Wildman Business Group" ], "product_ndc": [ "47682-456", "71679-302", "36800-545", "0363-0587", "63868-898", "80513-289", "37808-157", "83324-075", "53943-431", "70677-1121", "50844-600", "83324-058", "85828-372", "57237-302", "72036-252", "21130-428", "37835-571", "69396-173", "68998-146", "72476-263", "54162-940", "70000-0147", "53943-081", "50066-610", "87580-001", "49035-467", "17714-009", "59726-065", "37808-861", "70000-0253", "11822-0600", "54738-128", "63941-249", "54257-274", "83324-090", "49483-382", "0280-2090", "69168-318", "46122-691", "59961-616", "59961-620", "0574-7034", "17714-010", "41163-563", "58228-0071", "0363-0218", "42507-605", "36800-274", "57237-349", "63981-563", "57896-981", "55758-363", "21130-051", "51824-077", "0904-6783", "11822-6910", "56062-274", "17714-121", "70000-0014", "41520-157", "49035-563", "55910-765", "0280-2000", "49483-330", "49483-349", "63941-081", "24385-278", 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"49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL", "drugstructuredosagenumb": "650", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "4", "drugintervaldosagedefinition": "805", "drugdosagetext": "650 MG, Q4HR", "drugadministrationroute": "048", "drugindication": "PAIN", "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", "52cd19e4-a4b4-ecee-e063-6394a90ac33b", "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": "ZOFRAN /00955301/", "drugstructuredosagenumb": "4", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "8", "drugintervaldosagedefinition": "805", "drugdosagetext": "10 MG, BEDTIME", "drugadministrationroute": "042", "drugindication": "NAUSEA", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "BALSALAZIDE", "drugstructuredosagenumb": "750", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "750 MG, BID", "drugdosageform": "CAPSULE", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "BALSALAZIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "NORCO", "drugdosagetext": "325-5 MG, PRN", "drugadministrationroute": "048", "drugindication": "PAIN", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE BITARTRATE" }, "openfda": {} }, { "drugcharacterization": "2", "medicinalproduct": "GLIMEPIRIDE.", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "GLIMEPIRIDE" }, "openfda": { "application_number": [ "ANDA077911", "ANDA077091", "ANDA091220", "ANDA202112", "ANDA077370", "ANDA202759", "ANDA078181" ], "brand_name": [ "GLIMEPIRIDE", "GLIMEPIRIDE 3 MG" ], "generic_name": [ "GLIMEPIRIDE" ], "manufacturer_name": [ "Carlsbad Technology, Inc.", "Dr. Reddy's Laboratories Limited", "Micro Labs Limited", "Florida Pharmaceutical Products, LLC", "Solco Healthcare U.S., LLC", "Rising Pharma Holdings, Inc.", "BluePoint Laboratories", "Accord Healthcare Inc", "Aurobindo Pharma Limited", "Lifsa Drugs LLC" ], "product_ndc": [ "61442-115", "61442-116", "61442-117", "55111-320", "55111-321", "55111-322", "42571-100", "42571-101", "42571-102", "42571-103", "42571-104", "42571-105", "71921-214", "71921-215", "71921-216", "43547-394", "43547-395", "43547-396", "16571-773", "16571-774", "16571-775", "68001-584", "68001-585", "68001-586", "16729-001", "16729-002", "16729-003", "65862-579", "65862-580", "65862-581", "72336-641" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GLIMEPIRIDE" ], "rxcui": [ "199245", "199246", "199247", "153842", "1361493", "1361495" ], "spl_id": [ "2386d706-9dab-4ae0-e063-6394a90a8a06", "e3d50334-9896-b2f9-a481-8383eb84b16a", "34e9a6b6-450b-7d20-e063-6294a90ac831", "52fcdeaf-e64f-48bd-b90d-e7502b104ae1", "95a5568d-751c-4497-b70c-5cc358bbb2af", "f06a97e3-4349-4df3-87de-4479c1ed69bc", "39526e66-ce21-103e-e063-6294a90a5967", "415deb6c-47dc-ed2a-e063-6394a90a66fa", "cb22d2cd-964e-4ce6-8647-2abe0426b570", "8f56950f-d08d-44d4-9c7c-9830e9bfadb8" ], "spl_set_id": [ "72d88c6d-2f0a-4bf8-aa7f-1e1811794187", "07ad4366-4b21-f633-49f3-c2b35f88168d", "60e9397e-83b9-489e-9683-6f87e458bbaa", "8ff0de99-272e-4e68-9caf-69f3f146ac29", "86acdd9e-8637-43e4-8bf7-b3a123b871b8", "48ada723-8144-497d-afd6-a8c52a1dd3ff", "a01b0466-13f5-4c47-ae55-c5f1527d9414", "9b74fbac-9e04-4927-9981-1e3dace89c6d", "28eefc95-d92e-4555-b6c5-2933860b0610", "51157849-7990-4a8b-ae50-eda1baf93cfa" ], "package_ndc": [ "61442-115-01", "61442-115-05", "61442-115-10", "61442-116-01", "61442-116-05", "61442-116-10", "61442-117-01", "61442-117-05", "61442-117-10", "55111-320-30", "55111-320-01", "55111-320-05", "55111-320-79", "55111-320-78", "55111-321-30", "55111-321-01", "55111-321-05", "55111-321-79", "55111-321-78", "55111-322-30", "55111-322-01", "55111-322-05", "55111-322-79", "55111-322-78", "42571-100-01", "42571-100-05", "42571-101-01", "42571-101-05", "42571-102-01", "42571-102-05", "42571-103-01", "42571-103-05", "42571-104-01", "42571-104-05", "42571-105-01", "42571-105-05", "71921-214-01", "71921-214-50", "71921-215-01", "71921-215-50", "71921-216-01", "71921-216-50", "43547-394-10", "43547-394-50", "43547-395-10", "43547-395-50", "43547-396-10", "43547-396-50", "16571-773-01", "16571-773-50", "16571-774-01", "16571-774-50", "16571-775-01", "16571-775-50", "68001-584-00", "68001-584-03", "68001-585-00", "68001-585-03", "68001-586-00", "68001-586-03", "16729-001-01", "16729-001-16", "16729-001-17", "16729-002-01", "16729-002-16", "16729-002-17", "16729-003-01", "16729-003-16", "16729-003-17", "65862-579-01", "65862-579-05", "65862-579-99", "65862-580-01", "65862-580-05", "65862-580-99", "65862-581-01", "65862-581-25", "65862-581-05", "65862-581-99", "72336-641-01" ], "nui": [ "N0000175608", "M0020795" ], "pharm_class_epc": [ "Sulfonylurea [EPC]" ], "pharm_class_cs": [ "Sulfonylurea Compounds [CS]" ], "unii": [ "6KY687524K" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZOFRAN /00955301/", "drugindication": "VOMITING", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140724" } } }, { "safetyreportversion": "2", "safetyreportid": "10362959", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140805", "receiptdateformat": "102", "receiptdate": "20140813", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014TUS006962", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014TUS006962" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Palpitations", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Lymphadenopathy", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugdosagetext": "UNK", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20140716", "actiondrug": "5", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "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" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140718" } } }, { "safetyreportversion": "3", "safetyreportid": "10363235", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140805", "receiptdateformat": "102", "receiptdate": "20140808", "fulfillexpeditecriteria": "1", "companynumb": "US-TAKEDA-2014TUS005341", "duplicate": "1", "reportduplicate": { "duplicatesource": "TAKEDA", "duplicatenumb": "US-TAKEDA-2014TUS005341" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "3", "patientonsetageunit": "800", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Transaminases increased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugdosagetext": "300 MG, ONE DOSE", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20140624", "drugenddateformat": "102", "drugenddate": "20140624", "actiondrug": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "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": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugdosagetext": "300 MG ONE DOSE", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20140624", "drugenddateformat": "102", "drugenddate": "20140624", "actiondrug": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "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": "1", "medicinalproduct": "ENTYVIO", "drugauthorizationnumb": "125476", "drugdosagetext": "300 MG, ONE DOSE", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "COLITIS ULCERATIVE", "drugstartdateformat": "102", "drugstartdate": "20140610", "drugenddateformat": "102", "drugenddate": "20140610", "actiondrug": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO" ], "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" ] } } ] } } ] }