Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Repaglinide
Drug ID BADD_D01924
Description Repaglinide 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. Repaglinide 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. Repaglinide is extensively metabolized in the liver and excreted in bile. Repaglinide metabolites do not possess appreciable hypoglycemic activity. Approximately 90% of a single orally administered dose is eliminated in feces and 8% in urine.
Indications and Usage As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Marketing Status approved; investigational
ATC Code A10BX02
DrugBank ID DB00912
KEGG ID D00594
MeSH ID C072379
PubChem ID 65981
TTD Drug ID D0N5YA
NDC Product Code 65862-532; 33342-248; 65862-672; 57664-745; 63629-8447; 52562-500; 65862-671; 57237-158; 65372-1155; 33342-250; 57237-157; 63629-8448; 65862-670; 0574-0242; 72162-1113; 33342-249; 57237-159; 63629-9194; 72162-1112; 57664-747; 0574-0240; 0574-0241; 62756-206; 65727-010; 72162-1114; 60687-560; 63629-8449; 55111-065; 62147-0013; 62147-0055
UNII 668Z8C33LU
Synonyms repaglinide | repa-glinide | (S)-2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)-phenyl)butyl)amino)-2-oxoethyl)-benzoic acid | (+)-2-ethoxy-alpha-(((S)-alpha-isobutyl-o-piperidinobenzyl)carbamoyl)-p-toluic acid | (+)-repaglinide | AG-EE 623 ZW | AG-EE-623ZW | AGEE-623ZW | AG-EE-623-ZW | NovoNorm | GlucoNorm | AG-EE-624ZW | AG-EE 624ZW | repaglinide, (+-)-isomer | 2-ethoxy-N-(alpha-(2-methyl-1-propyl)-2-piperidinobenzyl)-4-carbamoylmethylbenzoic acid | AG-EE 388 ZW | 2-ethoxy-4-(2-((3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)benzoic acid | AG-EE 388 | (-)-repaglinide | repaglinide related compound E | repaglinide impurity E | 2-ethoxy-4-(2-(((1R)-3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino)-2-oxoethyl)benzoic acid | Prandin
Chemical Information
Molecular Formula C27H36N2O4
CAS Registry Number 135062-02-1
SMILES CCOC1=C(C=CC(=C1)CC(=O)NC(CC(C)C)C2=CC=CC=C2N3CCCCC3)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)
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Palpitations02.11.04.0120.001113%
Pancreatitis07.18.01.001--
Paraesthesia23.03.03.094; 17.02.06.005--
Pemphigoid23.03.01.004; 10.04.02.0020.002225%Not Available
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.0360.002225%Not Available
Rash23.03.13.001--Not Available
Refraction disorder06.02.04.004--Not Available
Renal failure20.01.03.0050.004451%Not Available
Rhinitis11.01.13.004; 22.07.03.006--
Shock24.06.02.0020.002782%Not Available
Sinus tachycardia02.03.03.0100.001113%
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.001669%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Suicide attempt19.12.01.0040.004673%
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.001669%
Thrombocytopenia01.08.01.002--Not Available
Tooth disorder07.09.05.001--Not Available
Unresponsive to stimuli17.02.05.0310.001113%Not Available
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.006--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Bradyphrenia19.10.03.002; 17.03.03.0040.002225%Not Available
Facial paresis17.04.03.0020.001113%
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