Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glimepiride
Drug ID BADD_D01023
Description First introduced in 1995, glimepiride is a member of the second-generation sulfonylurea (SU) drug class used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Type 2 diabetes is a metabolic disorder with increasing prevalences worldwide; it is characterized by insulin resistance in accordance with progressive β cell failure and long-term microvascular and macrovascular complications that lead to co-morbidities and mortalities. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. The main effect of SUs is thought to be effective when residual pancreatic β-cells are present,[A177715] as they work by stimulating the release of insulin from the pancreatic beta cells and they are also thought to exert extra-pancreatic effects, such as increasing the insulin-mediated peripheral glucose uptake.[A177709] Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells. Compared to [glipizide], another second SU drug, glimepiride has a longer duration of action. It is sometimes classified as a third-generation SU because it has larger substitutions than other second-generation SUs.[A177703] Compared to other SUs, glimepiride was associated with a lower risk of developing hypoglycemia and weight gain in clinical trials [A177709] as well as fewer cardiovascular effects than other SUs due to minimal effects on ischemic preconditioning of cardiac myocytes.[A177703] It is effective in reducing fasting plasma glucose, postprandial glucose, and glycosylated hemoglobin levels and is considered to be a useful, cost-effective treatment option for managing type 2 diabetes mellitus.[A177703] Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM. It is commonly marketed under the brand name Amaryl as oral tablets and is typically administered once daily.
Indications and Usage Glimepiride is indicated for the management of type 2 diabetes in adults as an adjunct to diet and exercise to improve glycemic control as monotherapy. It may also be indicated for use in combination with metformin or insulin to lower blood glucose in patients with type 2 diabetes whose high blood sugar levels cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic (a drug used to lower blood sugar levels) agent alone.[L10322]
Marketing Status approved
ATC Code A10BB12
DrugBank ID DB00222
KEGG ID D00593
MeSH ID C057619
PubChem ID 3476
TTD Drug ID D0B2GI
NDC Product Code 57451-1151; 65862-581; 43063-699; 50090-6415; 60429-919; 60760-248; 0039-0223; 68001-585; 70518-0405; 70518-2670; 71335-0484; 71335-1848; 62147-0009; 65862-579; 16729-001; 43063-630; 54458-966; 55111-320; 61919-448; 0039-0222; 65862-580; 68788-8095; 68788-8432; 69543-124; 69543-125; 0615-8332; 0615-8334; 65977-0010; 42571-100; 43063-122; 50090-1006; 51655-120; 55111-322; 69543-123; 70518-3652; 70518-3719; 71335-9655; 71610-236; 55154-8175; 60429-918; 61919-250; 68001-177; 68001-178; 68071-2228; 70518-2412; 70518-3627; 70518-3665; 71335-1885; 71335-9657; 72189-485; 42571-103; 50090-6322; 50268-360; 60429-920; 63187-698; 67296-1247; 68001-586; 68084-788; 71205-779; 43063-587; 43063-946; 50090-3172; 50090-6394; 68084-326; 68645-573; 71335-1886; 0615-8333; 55111-041; 66039-800; 72640-019; 16571-773; 43063-121; 50268-359; 51655-489; 67296-1246; 68084-327; 70518-3664; 71335-9654; 72789-048; 14445-018; 16729-002; 43063-698; 43547-394; 43547-396; 61442-115; 63187-641; 68001-179; 68001-584; 68645-572; 70518-3709; 70934-726; 71205-773; 42571-101; 43063-697; 50090-1526; 50090-3189; 50090-6426; 50268-358; 54458-967; 61442-117; 63187-486; 0039-0221; 63629-3043; 68788-7694; 70518-3722; 70934-727; 72189-453; 16571-774; 16571-775; 42571-102; 42571-105; 43547-395; 55111-321; 60760-800; 61442-116; 63629-5650; 68071-4869; 68788-8066; 71335-0180; 62147-0300; 16729-003; 42571-104; 50090-1987; 51655-383; 51655-565
UNII 6KY687524K
Synonyms glimepiride | glymepiride | 1-(4-(2-(3-ethyl-4-methyl-2-oxo-3-pyrrolinecarboxamido)ethyl)phenylsulfonyl)-3-(4-methylcyclohexyl)urea | Amaryl | Amarel | HOE 490 | HOE-490 | Roname
Chemical Information
Molecular Formula C24H34N4O5S
CAS Registry Number 261361-60-8
SMILES CCC1=C(CN(C1=O)C(=O)NCCC2=CC=C(C=C2)S(=O)(=O)NC(=O)NC3CCC(CC3)C)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)
Hypokalaemia14.05.03.0020.000127%
Hyponatraemia14.05.04.0020.000127%
Hypopnoea22.02.01.021---
Hypotension24.06.03.002--
Hypothyroidism05.02.03.001; 14.11.01.0120.000042%
Ileus07.13.01.0010.000064%
Incontinence07.01.06.011; 17.05.01.006; 20.02.02.0040.000106%-
Increased appetite08.01.09.027; 14.03.01.003---
Influenza11.05.03.001; 22.07.02.001---
Injection site induration08.02.03.007; 12.07.03.0070.000093%-
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease10.02.01.033; 22.01.02.0030.000297%-
Intestinal obstruction07.13.01.0020.000042%-
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.000200%-
Ketosis14.01.01.0010.000042%-
Laboratory test abnormal13.18.01.001---
Lactic acidosis14.01.01.0020.000191%-
Leukopenia01.02.02.001---
Lip oedema07.05.04.004; 10.01.05.004; 23.04.01.0060.000085%-
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.000093%-
Liver disorder09.01.08.0010.000085%-
Loss of consciousness17.02.04.0040.000594%-
Lymphadenopathy01.09.01.0020.000042%-
Malaise08.01.01.0030.000429%
Melaena07.12.02.004; 24.07.02.0130.000064%-
Menopausal symptoms21.02.02.002---
Mental disability26.01.01.001---
Mental impairment17.03.03.002; 19.21.02.003---
Mitral valve incompetence02.07.01.0020.000042%-
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ADReCS-Target
Drug Name ADR Term Target
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