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 cell carcinoma16.08.02.002; 20.01.04.0030.000053%-
Hypertransaminasaemia09.01.02.0050.000133%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000350%
Conjunctival pallor01.03.02.015; 06.07.01.0040.000053%-
Acute kidney injury20.01.03.0160.001274%
Hepatic cancer09.04.02.008; 16.07.02.0040.000080%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.000106%-
Anal incontinence07.01.06.029; 17.05.01.0210.000080%
Ureterolithiasis20.04.03.0030.000053%-
Abnormal loss of weight14.03.02.0190.000186%-
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000053%-
Anaemia of chronic disease01.03.04.0020.000265%-
Chronic gastritis07.08.02.005; 10.04.04.011; 11.07.01.0160.000106%-
Drowning08.04.01.014; 12.01.18.0030.000053%-
Faeces pale07.01.03.0050.000053%-
Malignant ascites07.07.01.004; 16.32.03.0130.000106%-
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000080%-
Mesenteric vein thrombosis07.15.02.013; 24.01.08.0040.000106%-
Metastases to abdominal cavity07.21.03.006; 16.22.02.0100.000080%-
Metastases to adrenals05.01.04.007; 16.22.02.0120.000053%-
Metastases to bone15.09.03.006; 16.22.02.0050.000212%-
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000716%-
Mitral valve prolapse02.07.01.0080.000053%-
Obstruction gastric07.13.04.0020.000212%
Oesophageal dilatation07.11.02.0050.000053%-
Overweight14.03.02.0210.000080%-
Pancreatic carcinoma metastatic07.21.09.006; 16.13.10.0030.002070%-
Pancreatic carcinoma recurrent07.21.09.007; 16.13.10.0040.000133%-
Pancreatic cyst07.18.03.003; 16.05.01.0050.000249%-
Pancreatitis relapsing07.18.01.0110.000053%-
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ADReCS-Target
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