Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tolbutamide
Drug ID BADD_D02240
Description Tolbutamide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It is structurally similar to acetohexamide, chlorpropamide and tolazamide and belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Tolbutamide appears to be metabolized in the liver. Tolbutamide and its metabolites are excreted in urine (75-85%) and feces.
Indications and Usage For treatment of NIDDM (non-insulin-dependent diabetes mellitus) in conjunction with diet and exercise.
Marketing Status Prescription; Discontinued
ATC Code A10BB03; V04CA01
DrugBank ID DB01124
KEGG ID D00380
MeSH ID D014044
PubChem ID 5505
TTD Drug ID D06OIV
NDC Product Code 46438-0650; 46438-0002; 52537-003
Synonyms Tolbutamide | Artosin | Diabetol | Diaval | Orabet | Orinase | Tolbutamid R.A.N. | Apo-Tolbutamide | Dolipol | Rastinon
Chemical Information
Molecular Formula C12H18N2O3S
CAS Registry Number 64-77-7
SMILES CCCCNC(=O)NS(=O)(=O)C1=CC=C(C=C1)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Bone marrow failureATP-binding cassette sub-family C member 8Q09428T9148010669529; 9731005; 9351598
HypoglycaemiaCytochrome P450 2C9P11712T192449663807; 9698079; 11523725
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Agranulocytosis01.02.03.001--Not Available
Alcohol intolerance14.02.01.001--
Aplastic anaemia01.03.03.002--Not Available
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Erythema23.03.06.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Haemolytic anaemia01.06.03.002--Not Available
Headache17.14.01.001--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hyponatraemia14.05.04.002--
Jaundice cholestatic09.01.01.005--Not Available
Leukopenia01.02.02.001--Not Available
Nausea07.01.07.001--
Pancytopenia01.03.03.003--Not Available
Photosensitivity reaction23.03.09.003--
Porphyria non-acute09.01.10.003; 03.08.01.004; 23.03.01.012; 14.14.01.004--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rash morbilliform23.03.13.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.001--Not Available
The 1th Page    1    Total 1 Pages