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)
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000318%Not Available
Jaundice cholestatic09.01.01.0050.000159%Not Available
Joint stiffness15.01.02.0030.000223%Not Available
Joint swelling15.01.02.0040.000600%Not Available
Ketoacidosis14.01.01.0080.000159%Not Available
Ketosis14.01.01.0010.000080%Not Available
Lactic acidosis14.01.01.0020.000265%Not Available
Laryngeal pain22.12.03.010--
Leukocytosis01.02.01.0020.000425%
Leukopenia01.02.02.0010.000239%Not Available
Lichen planus23.03.08.0010.000053%Not Available
Linear IgA disease23.03.01.015; 10.04.02.0060.000053%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000387%Not Available
Lipoma16.18.01.001; 15.09.01.0010.000053%Not Available
Liver disorder09.01.08.0010.000409%Not Available
Lung disorder22.02.07.0010.000212%Not Available
Lung infiltration22.01.02.0040.000106%Not Available
Lymphadenopathy01.09.01.0020.000700%Not Available
Malabsorption14.02.01.004; 07.17.01.0010.000170%
Malaise08.01.01.003--
Malignant melanoma23.08.01.001; 16.03.01.0010.000080%Not Available
Mass08.03.05.0030.000053%Not Available
Melaena24.07.02.013; 07.12.02.0040.000196%Not Available
Metabolic acidosis14.01.01.0030.000345%Not Available
Metastases to liver09.04.02.004; 16.22.02.0010.001804%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000478%Not Available
Microcytic anaemia01.03.02.0080.000080%Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mitral valve incompetence02.07.01.0020.000080%Not Available
Movement disorder17.01.02.0100.000170%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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