Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gliclazide
Drug ID BADD_D01022
Description Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It has been classified differently according to its drug properties in which based on its chemical structure, gliclazide is considered a first-generation sulfonylurea due to the structural presence of a sulfonamide group able to release a proton and the presence of one aromatic group.[A39546] On the other hand, based on the pharmacological efficacy, gliclazide is considered a second-generation sulfonylurea which presents a higher potency and a shorter half-life.[T238, T360] Gliclazide 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. Gliclazide has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Gliclazide is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).
Indications and Usage For the treatment of NIDDM in conjunction with diet and exercise.
Marketing Status approved
ATC Code A10BB09
DrugBank ID DB01120
KEGG ID D01599
MeSH ID D005907
PubChem ID 3475
TTD Drug ID D0M2MR
NDC Product Code 58793-014
UNII G4PX8C4HKV
Synonyms Gliclazide | Glyclazide | Gliklazid | Diamicron | S-1702 | S 1702 | S1702 | S-852 | S 852 | S852 | Diaglyk | Gen-Gliclazide | Gen Gliclazide | Glyade | Novo-Gliclazide | Novo Gliclazide | Diaikron | Diabrezide
Chemical Information
Molecular Formula C15H21N3O3S
CAS Registry Number 21187-98-4
SMILES CC1=CC=C(C=C1)S(=O)(=O)NC(=O)NN2CC3CCCC3C2
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)
Osteoarthritis15.01.04.001---
Otitis media04.05.01.001; 11.01.05.004--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor08.01.03.032; 23.03.03.031; 24.03.04.001---
Palpitations02.11.04.012--
Pancreatitis acute07.18.01.002---
Pancytopenia01.03.03.003---
Paraesthesia17.02.06.005; 23.03.03.094--
Paresis17.01.04.008---
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Photosensitivity reaction23.03.09.003--
Pneumonia11.01.09.003; 22.07.01.003---
Polyuria20.02.03.002---
Porphyria non-acute03.08.01.004; 09.01.10.003; 14.14.01.004; 23.03.01.012---
Prostatic disorder21.04.01.001---
Pruritus23.03.12.001--
Rash23.03.13.001---
Rash erythematous23.03.13.029---
Rash maculo-papular23.03.13.004--
Rash pruritic23.03.13.030---
Renal cyst16.27.01.001; 20.01.04.001---
Renal failure20.01.03.005---
Retinal disorder06.08.03.005---
Rhinitis11.01.13.004; 22.07.03.006--
Salivary hypersecretion07.06.01.009---
Seizure17.12.03.001--
Sensory disturbance17.02.07.006---
Sensory loss17.02.07.007---
Sinusitis11.01.13.005; 22.07.03.007--
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