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 For use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Also for use in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin or a PPARγ agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Marketing Status Prescription
ATC Code A10BH01
DrugBank ID DB01261
KEGG ID D08516
MeSH ID D000068900
PubChem ID 4369359
TTD Drug ID D0U2JP
NDC Product Code 55154-5042; 50090-3527; 0006-0221; 50090-3472; 0006-0112; 50090-4084; 50090-4087; 50090-5517; 50090-4086; 59285-042; 55154-5040; 50090-5547; 50090-5585; 0006-0277
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatic steatosis14.08.04.005; 09.01.07.0030.000875%Not Available
Hepatitis09.01.07.0040.000375%Not Available
Hepatitis cholestatic09.01.01.0020.000500%Not Available
Hepatocellular injury09.01.07.008--Not Available
Hepatomegaly09.01.05.0010.000500%Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.0070.000065%Not Available
Herpes zoster23.09.03.002; 11.05.02.003--
Hiatus hernia07.16.01.001; 22.09.02.0040.002126%Not Available
Hunger14.03.02.012; 08.01.09.0030.000375%Not Available
Hyperbilirubinaemia09.01.01.003; 01.06.04.003; 14.11.01.0100.000500%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000250%
Hypercholesterolaemia14.08.01.0010.001375%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.002001%
Hyperhidrosis23.02.03.004; 08.01.03.0280.002001%
Hyperkalaemia14.05.03.0010.000875%
Hyperphagia19.09.01.005; 14.03.01.007; 07.01.06.0180.000250%Not Available
Hypersensitivity10.01.03.0030.001625%
Hypertension24.08.02.0010.007502%
Hypoaesthesia17.02.06.023--Not Available
Hypoalbuminaemia14.10.01.002; 09.01.02.0030.000500%
Hypocalcaemia14.04.01.0040.000500%
Hypoglycaemia14.06.03.001; 05.06.03.0010.006252%
Hypoglycaemic coma17.02.09.005; 14.06.03.004; 05.06.03.0040.000250%Not Available
Hypokalaemia14.05.03.0020.001751%
Hypokinesia17.01.02.0090.000065%Not Available
Hypomagnesaemia14.04.02.0010.000250%
Hyponatraemia14.05.04.0020.001751%
Hypophosphataemia14.04.03.0010.000375%
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.0010.002126%
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