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)
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.002126%Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.0070.000875%
Gingivitis11.01.04.013; 07.09.03.0030.000375%
Glaucoma06.03.01.0020.001250%
Glomerular filtration rate decreased13.13.01.0090.000625%Not Available
Glycosylated haemoglobin decreased13.02.02.0120.000250%Not Available
Glycosylated haemoglobin increased13.02.02.0050.002626%Not Available
Goitre05.02.01.001; 14.11.01.0080.000375%Not Available
Gout15.01.06.001; 14.09.01.0010.001000%Not Available
Granuloma23.03.15.001; 08.01.05.0010.000375%Not Available
Haemangioma of liver16.06.01.003; 24.03.06.006; 09.04.01.0030.000375%Not Available
Haematemesis07.12.02.002; 24.07.02.0110.000875%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.000750%Not Available
Haematocrit decreased13.01.05.0010.000375%Not Available
Haematuria24.07.01.047; 20.02.01.0060.001500%
Blood urine present13.13.02.0020.000250%Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolytic anaemia01.06.03.0020.000250%Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.000750%
Hallucination, visual19.10.02.0040.000250%Not Available
Headache17.14.01.001--
Heart rate increased13.14.04.0020.000750%Not Available
Heart rate irregular13.14.04.0030.000625%Not Available
Henoch-Schonlein purpura24.07.06.003; 23.06.01.002; 10.02.02.004; 01.01.04.0010.000250%Not Available
Hepatic cirrhosis09.01.04.0010.000326%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000875%Not Available
Hepatic failure09.01.03.0020.000294%
Hepatic function abnormal09.01.02.0010.001000%Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000250%Not Available
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