Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vildagliptin
Drug ID BADD_D02357
Description Vildagliptin (LAF237) is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired.[A232488] By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently results in improved glycemic control.[L32803] In clinical trials, vildagliptin has a relatively low risk of hypoglycemia.[A232488] Oral vildagliptin was approved by the European Medicines Agency in 2008 for the treatment of type II diabetes mellitus in adults as monotherapy or in combination with [metformin], a sulfonylurea, or a thiazolidinedione in patients with inadequate glycemic control following monotherapy. It is marketed as Galvus.[L32803] Vildagliptin is also available as Eucreas, a fixed-dose formulation with metformin for adults in who do not adequately glycemic control from monotherapy.[L32813] Vildagliptin is currently under investigation in the US.
Indications and Usage Vildagliptin is indicated in the treatment of type II diabetes mellitus in adults. As monotherapy, vildagliptin is indicated in adults inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.[L32803] It is also indicated as dual therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione in adults patients with insufficient glycemic control despite maximal tolerated dose of monotherapy.[L32803] Vildagliptin is also marketed in a combination product with [metformin] for the treatment of adults with type II diabetes mellitus who inadequately respond to either monotherapy of vildagliptin or metformin. This fixed-dose formulation can be used in combination with a sulphonylurea or insulin (i.e., triple therapy) as an adjunct to diet and exercise in adults who do not achieve adequate glycemic control with monotherapy or dual therapy.[L32813]
Marketing Status approved; investigational
ATC Code A10BH02
DrugBank ID DB04876
KEGG ID D07080
MeSH ID D000077597
PubChem ID 5251896
TTD Drug ID D0L3DK
NDC Product Code 65727-051; 69037-0028; 66651-102; 50370-0032; 65372-1200
UNII I6B4B2U96P
Synonyms Vildagliptin | (2S)-(((3-Hydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile | NVP-LAF237 | NVP LAF237 | Galvus
Chemical Information
Molecular Formula C17H25N3O2
CAS Registry Number 274901-16-5
SMILES C1CC(N(C1)C(=O)CNC23CC4CC(C2)CC(C4)(C3)O)C#N
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)
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Blister12.01.06.002; 23.03.01.001---
Blood glucose decreased13.02.02.001---
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001---
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypoglycaemia05.06.03.001; 14.06.03.001--
Infection11.01.08.002---
Liver function test abnormal13.03.04.030---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pancreatitis07.18.01.001--
Skin disorder23.03.03.007---
Skin exfoliation23.03.07.003---
Tremor17.01.06.002--
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