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)
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000499%
Haemolytic anaemia01.06.03.0020.000053%Not Available
Haemorrhoids07.15.03.001; 24.10.02.0020.000159%
Hallucination, visual19.10.04.0070.000170%Not Available
Headache17.14.01.001--
Henoch-Schonlein purpura10.02.02.004; 01.01.04.001; 24.07.06.003; 23.06.01.0020.000117%Not Available
Hepatic cirrhosis09.01.04.0010.000265%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000239%Not Available
Hepatic failure09.01.03.0020.000239%
Hepatic function abnormal09.01.02.0010.000186%Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000053%Not Available
Hepatic steatosis14.08.04.005; 09.01.07.0030.000239%Not Available
Hepatitis09.01.07.0040.000106%Not Available
Hepatitis alcoholic09.01.07.0290.000053%Not Available
Hepatitis cholestatic09.01.01.0020.000106%Not Available
Hepatomegaly09.01.05.0010.000143%Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.0070.000053%Not Available
Herpes zoster11.05.02.003; 23.11.05.005; 17.09.03.026--
Hiatus hernia22.09.02.004; 07.16.01.0010.000425%Not Available
Hunger14.03.02.012; 08.01.09.0030.000207%Not Available
Hyperaemia24.03.02.0020.000053%Not Available
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.0030.000106%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000080%
Hypercholesterolaemia14.08.01.0010.000292%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000748%
Hyperhidrosis08.01.03.028; 23.02.03.0040.000960%
Hyperkalaemia14.05.03.0010.000186%
Hyperphagia19.09.01.005; 07.01.06.018; 14.03.01.0070.000180%Not Available
Hypersensitivity10.01.03.0030.000769%
Hypertension24.08.02.0010.001672%
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ADReCS-Target
Drug Name ADR Term Target
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