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 approved; investigational
ATC Code A10BB03; V04CA01
DrugBank ID DB01124
KEGG ID D00380
MeSH ID D014044
PubChem ID 5505
TTD Drug ID D06OIV
NDC Product Code 46438-0002; 46438-0650; 52537-003
UNII 982XCM1FOI
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Agranulocytosis01.02.03.001---
Alcohol intolerance14.02.01.001--
Aplastic anaemia01.03.03.002---
Asthenia08.01.01.001---
Cerebrovascular disorder17.08.02.002; 24.03.05.002---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Dermatitis allergic10.01.03.014; 23.03.04.003---
Diarrhoea07.02.01.001--
Drug interaction08.06.03.001---
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Erythema23.03.06.001---
Gastrointestinal disorder07.11.01.001---
Haemolytic anaemia01.06.03.002---
Headache17.14.01.001--
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypoglycaemia05.06.03.001; 14.06.03.001--
Hyponatraemia14.05.04.002--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Jaundice cholestatic09.01.01.005---
Lactic acidosis14.01.01.002---
Leukopenia01.02.02.001---
Nausea07.01.07.001--
Pancytopenia01.03.03.003---
Photosensitivity reaction23.03.09.003--
Porphyria non-acute03.08.01.004; 09.01.10.003; 14.14.01.004; 23.03.01.012---
Pruritus23.03.12.001--
Rash23.03.13.001---
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ADReCS-Target
Drug Name ADR Term Target
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