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)
Ischaemic cardiomyopathy24.04.04.019; 02.04.01.0040.000080%Not Available
Hypoacusis04.02.01.0060.000159%
Peripheral swelling08.01.03.053; 02.05.04.0150.000897%Not Available
Osteopenia15.02.03.003; 14.04.04.0040.000143%Not Available
Gallbladder polyp16.06.02.002; 09.03.02.0030.000053%Not Available
Muscle tightness15.05.03.007--Not Available
Balance disorder17.02.02.007; 08.01.03.0810.000340%Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000170%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000053%
Lacunar infarction24.04.06.009; 17.08.01.0160.000053%Not Available
Dyschezia07.02.03.0050.000117%Not Available
Bile duct stenosis09.02.02.0010.000212%
Gastric ulcer helicobacter11.02.18.003; 07.04.03.007--Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000053%Not Available
Prostatomegaly21.04.01.0020.000292%Not Available
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.000212%Not Available
Metastases to peritoneum16.22.02.008; 07.21.03.0030.000239%Not Available
Vascular calcification24.03.02.0130.000080%Not Available
Diastolic dysfunction02.04.02.0220.000053%Not Available
Adenocarcinoma pancreas16.13.10.002; 07.21.09.0030.001061%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Epigastric discomfort07.01.02.0040.000117%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Acquired haemophilia01.01.01.0020.000053%Not Available
Helicobacter gastritis11.02.18.002; 07.19.03.007--Not Available
Varices oesophageal07.15.05.001; 24.10.02.004; 09.01.06.0090.000080%Not Available
Faecaloma07.01.03.0040.000053%Not Available
Pulmonary mass22.02.07.0040.000780%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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