Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nateglinide
Drug ID BADD_D01539
Description Nateglinide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the meglitinide class of short-acting insulin secretagogues, which act by binding to β cells of the pancreas to stimulate insulin release. Nateglinide is an amino acid derivative that induces an early insulin response to meals decreasing postprandial blood glucose levels. It should only be taken with meals and meal-time doses should be skipped with any skipped meal. Approximately one month of therapy is required before a decrease in fasting blood glucose is seen. Meglitnides may have a neutral effect on weight or cause a slight increase in weight. The average weight gain caused by meglitinides appears to be lower than that caused by sulfonylureas and insulin and appears to occur only in those naïve to oral antidiabetic agents. Due to their mechanism of action, meglitinides may cause hypoglycemia although the risk is thought to be lower than that of sulfonylureas since their action is dependent on the presence of glucose. In addition to reducing postprandial and fasting blood glucose, meglitnides have been shown to decrease glycosylated hemoglobin (HbA1c) levels, which are reflective of the last 8-10 weeks of glucose control. Meglitinides appear to be more effective at lowering postprandial blood glucose than metformin, sulfonylureas and thiazolidinediones. Nateglinide is extensively metabolized in the liver and excreted in urine (83%) and feces (10%). The major metabolites possess less activity than the parent compound. One minor metabolite, the isoprene, has the same potency as its parent compound.
Indications and Usage For the treatment of non-insulin dependent-diabetes mellitus in conjunction with diet and exercise.
Marketing Status approved; investigational
ATC Code A10BX03
DrugBank ID DB00731
KEGG ID D01111
MeSH ID D000077715
PubChem ID 5311309
TTD Drug ID D06PSS
NDC Product Code 75834-205; 16571-758; 55111-328; 60687-673; 60687-684; 68084-459; 70771-1015; 49884-984; 64380-168; 68382-721; 51407-656; 60429-434; 0591-3354; 0591-3355; 55111-329; 70771-1016; 60429-435; 68382-722; 72241-003; 53747-020; 51407-657; 68084-458; 53747-052; 49884-985; 64380-167; 72241-002; 53104-7595; 65096-0108; 16571-759; 71209-030; 71209-031; 75834-206
UNII 41X3PWK4O2
Synonyms Nateglinide | Senaglinide | Nate-Glinide | Fastic | Starsis | DJN 608 | AY 4166 | AY-4166 | AY4166 | A 4166 | A-4166 | A4166 | Nateglinide, (D-Phe)-isomer | Starlix | N-((4-Isopropylcyclohexyl)carbonyl)phenylalanine | Nateglinide, (cis,D-Phe)-isomer
Chemical Information
Molecular Formula C19H27NO3
CAS Registry Number 105816-04-4
SMILES CC(C)C1CCC(CC1)C(=O)NC(CC2=CC=CC=C2)C(=O)O
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)
Pruritus23.03.12.001--
Rash23.03.13.001---
Thirst08.01.09.021; 14.03.02.007---
Tremor17.01.06.002--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Urine output increased13.13.03.002---
Hepatic enzyme increased13.03.04.028---
Malnutrition14.03.02.004---
Hepatobiliary disease09.01.08.003---
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