Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sitagliptin
Drug ID BADD_D02029
Description Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus[Label,A2260,A2255,A2256]. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar[Label,A2255]. Sitagliptin was granted FDA approval on October 16, 2006[L6061].
Indications and Usage Sitagliptin is indicated for the management of glycemic control in type 2 diabetes mellitus along with diet and exercise[Label].
Marketing Status approved; investigational
ATC Code A10BH01
DrugBank ID DB01261
KEGG ID D08516
MeSH ID D000068900
PubChem ID 4369359
TTD Drug ID D0U2JP
NDC Product Code 50090-4084; 0006-0277; 50090-4086; 50090-5517; 55154-5040; 50090-5547; 55154-5042; 50090-5585; 0006-0221; 50090-3527; 59285-042; 0006-0112; 50090-4087; 50090-3472
UNII QFP0P1DV7Z
Synonyms Sitagliptin Phosphate | Phosphate, Sitagliptin | Sitagliptin Phosphate Monohydrate | Monohydrate, Sitagliptin Phosphate | Phosphate Monohydrate, Sitagliptin | Sitagliptin Monophosphate Monohydrate | Monohydrate, Sitagliptin Monophosphate | Monophosphate Monohydrate, Sitagliptin | MK 0431 | 0431, MK | MK0431 | MK-0431 | Sitagliptin Phosphate Anhydrous | Anhydrous, Sitagliptin Phosphate | Phosphate Anhydrous, Sitagliptin | Sitagliptin | 4-Oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine | Januvia
Chemical Information
Molecular Formula C16H15F6N5O
CAS Registry Number 486460-32-6
SMILES C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)CC(CC3=CC(=C(C=C3F)F)F)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)
Colitis microscopic07.08.01.0110.000106%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000233%Not Available
Testis cancer21.13.02.001; 16.25.03.0010.000053%Not Available
Anxiety disorder19.06.01.0020.000159%Not Available
Injection site nodule23.07.04.009; 12.07.03.034; 08.02.03.0340.000297%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000133%Not Available
Dyslipidaemia14.08.04.0150.000212%Not Available
Angiopathy24.03.02.0070.000117%Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Prostate cancer16.25.01.001; 21.04.02.0020.000239%Not Available
Adverse event08.06.01.0100.004829%Not Available
Abdominal hernia07.16.06.0050.000159%Not Available
Arterial disorder24.03.02.0200.000080%Not Available
Biliary tract disorder09.02.03.0010.000053%Not Available
Bladder disorder20.03.01.0020.000117%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.0030.000488%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Diabetic complication14.07.03.002; 05.07.03.0020.000212%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000106%Not Available
Gastrointestinal motility disorder07.02.03.0010.000117%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.0140.000080%Not Available
Intervertebral disc degeneration15.10.01.0020.000106%Not Available
Malnutrition14.03.02.0040.000425%Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000133%Not Available
Spondylitis15.01.09.0020.000053%Not Available
Decreased appetite08.01.09.028; 14.03.01.0050.001353%
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ADReCS-Target
Drug Name ADR Term Target
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