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)
Renal atrophy20.01.06.0010.000106%Not Available
Splenic vein thrombosis24.01.03.005; 01.09.02.0190.000053%Not Available
Throat cancer22.08.02.008; 16.19.02.0070.000159%Not Available
Pancreatic mass07.18.02.0070.000186%Not Available
Anaemia of malignant disease01.03.04.0030.000053%Not Available
Pancreatic fistula07.11.05.0160.000053%
Metastases to spleen16.22.02.025; 01.09.02.0100.000106%Not Available
Adrenal mass05.01.03.0030.000159%Not Available
Insulin-requiring type 2 diabetes mellitus14.06.01.009; 05.06.01.0090.000212%Not Available
Small intestine carcinoma16.13.13.002; 07.21.01.0160.000080%Not Available
Hepatic mass09.01.08.0150.000053%Not Available
Biliary dilatation09.02.03.0040.000239%Not Available
Aortic dilatation24.03.04.0070.000053%Not Available
Pancreatic carcinoma stage IV16.13.10.005; 07.21.09.0080.000106%Not Available
Appendix disorder07.11.01.0200.000053%Not Available
Malignant peritoneal neoplasm16.13.04.005; 07.21.03.0050.000053%Not Available
Deformity08.01.03.0220.000053%Not Available
Seronegative arthritis15.01.01.0150.000239%Not Available
Gallbladder enlargement09.03.02.0050.000053%Not Available
Splenic granuloma01.09.02.0130.000080%Not Available
Pelvic fluid collection21.07.04.011; 07.07.01.0090.000080%Not Available
Pneumobilia09.01.05.0110.000186%Not Available
Retroperitoneal lymphadenopathy07.07.01.012; 01.09.01.0290.000053%Not Available
Hyperlipasaemia14.11.01.0230.000159%Not Available
Pancreatic neuroendocrine tumour metastatic16.24.02.006; 05.08.01.015; 07.21.09.0100.000053%Not Available
Autoimmune pancreatitis10.04.08.010; 07.18.01.0090.000080%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000053%Not Available
Internal haemorrhage24.07.01.0720.000080%Not Available
Skin texture abnormal23.03.03.068--Not Available
Gastrointestinal wall thickening07.01.06.0320.000106%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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