{"id":"tolbutamide","rwe":[],"tags":[{"label":"Sulfonylurea","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sulfonylurea receptor 1, Kir6.2","category":"target"},{"label":"ABCC8","category":"gene"},{"label":"KCNJ11","category":"gene"},{"label":"A10BB03","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Diabetes mellitus type 2","category":"indication"},{"label":"Diagnostic Test for Pancreatic Islet Cell Adenoma","category":"indication"},{"label":"Approved 1960s","category":"decade"},{"label":"Hypoglycemic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":59.243,"date":"","count":8,"signal":"Lip infection","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=59)"},{"llr":47.142,"date":"","count":8,"signal":"Bronchitis viral","source":"DrugCentral FAERS","actionTaken":"Reported 8 times (LLR=47)"}],"drugInteractions":[{"url":"/drug/cyp2c9-substrates","drug":"CYP2C9 Substrates","action":"Use caution","effect":"Strong CYP2C9 Inhibitors - CYP2C9 Substrates","source":"DrugCentral","drugSlug":"cyp2c9-substrates"},{"url":"/drug/fosaprepitant","drug":"fosaprepitant","action":"Monitor closely","effect":"May interact with Fosaprepitant","source":"DrugCentral","drugSlug":"fosaprepitant"},{"url":"/drug/levofloxacin","drug":"levofloxacin","action":"Monitor closely","effect":"May interact with Levofloxacin","source":"DrugCentral","drugSlug":"levofloxacin"},{"url":"/drug/norfloxacin","drug":"norfloxacin","action":"Monitor closely","effect":"May interact with Norfloxacin","source":"DrugCentral","drugSlug":"norfloxacin"},{"url":"/drug/rifampicin","drug":"rifampicin","action":"Monitor closely","effect":"May interact with Rifampin","source":"DrugCentral","drugSlug":"rifampicin"},{"url":"/drug/voriconazole","drug":"voriconazole","action":"Monitor closely","effect":"May interact with Voriconazole","source":"DrugCentral","drugSlug":"voriconazole"}],"commonSideEffects":[],"contraindications":["Alcoholism","Asthenia","Disease of liver","Fever greater than 100.4 Fahrenheit","Hepatic porphyria","Hypoglycemic disorder","Hypopituitarism","Kidney disease","Primary adrenocortical insufficiency","Prolonged-Severe Nausea and Vomiting","Surgical procedure","Traumatic injury"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TOLBUTAMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:45:33.468501+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:45:40.358117+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TOLBUTAMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:45:41.125984+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Sulfonylurea receptor 1, Kir6.2 blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:45:41.707183+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL782/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:45:41.610017+00:00"}},"allNames":"aglicid","offLabel":[],"synonyms":["tolbutamide","aglicid","arkozal","tolbutamid","tolumid","tolumide","tolbutamide sodium, sterile","tolbutamide sodium","tolbutamida"],"timeline":[{"date":"1961-06-22","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Tolbutamide, also known as Aglicid, is a small molecule sulfonylurea drug that targets the sulfonylurea receptor 1, Kir6.2. Originally developed and currently owned by various generic manufacturers, it was first approved by the FDA in 1961 for the treatment of type 2 diabetes mellitus and diagnostic testing for pancreatic islet cell adenoma. As an off-patent medication, tolbutamide is widely available in generic form from multiple manufacturers. Key safety considerations include its potential to cause hypoglycemia and interactions with other medications. Tolbutamide has a half-life of 7.0 hours and bioavailability of 85%.","approvals":[{"date":"1961-06-22","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Aglicid","ecosystem":[{"indication":"Diabetes mellitus type 2","otherDrugs":[{"name":"acarbose","slug":"acarbose","company":"Bayer Hlthcare"},{"name":"acetohexamide","slug":"acetohexamide","company":"Lilly"},{"name":"albiglutide","slug":"albiglutide","company":"Glaxosmithkline Llc"},{"name":"alogliptin","slug":"alogliptin","company":"Takeda Pharms Usa"}],"globalPrevalence":537000000},{"indication":"Diagnostic Test for Pancreatic Islet Cell Adenoma","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Sulfonylurea receptor 1, Kir6.2","novelty":"Follow-on","targets":[{"gene":"ABCC8","source":"DrugCentral","target":"Sulfonylurea receptor 1, Kir6.2","protein":"ATP-binding cassette sub-family C member 8"},{"gene":"KCNJ11","source":"DrugCentral","target":"Sulfonylurea receptor 1, Kir6.2","protein":"ATP-sensitive inward rectifier potassium channel 11"}],"modality":"Small Molecule","drugClass":"Sulfonylurea","explanation":"","oneSentence":"","technicalDetail":"Tolbutamide acts as an agonist at the sulfonylurea receptor 1 (SUR1), a subunit of the ATP-sensitive potassium channel (K_ATP), which is composed of Kir6.2 and SUR1. By binding to SUR1, tolbutamide inhibits the K_ATP channel, leading to membrane depolarization, opening of voltage-dependent calcium channels, and subsequent insulin release from pancreatic beta cells."},"commercial":{"launchDate":"1961","_launchSource":"DrugCentral (FDA 1961-06-22, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2696","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TOLBUTAMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TOLBUTAMIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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