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)
Faeces pale07.01.03.0050.000250%Not Available
Malignant ascites07.07.01.004; 16.32.03.0130.000098%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000065%Not Available
Mesenteric vein thrombosis24.01.08.004; 07.15.02.0130.000375%Not Available
Metastases to abdominal cavity16.22.02.010; 07.21.03.0060.000098%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000250%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000261%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000815%Not Available
Mitral valve prolapse02.07.01.0080.000250%Not Available
Obstruction gastric07.13.04.0020.000750%
Oesophageal dilatation07.11.02.0050.000250%Not Available
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.002088%Not Available
Pancreatic carcinoma recurrent07.21.09.007; 16.13.10.0040.000163%Not Available
Pancreatic cyst16.05.01.005; 07.18.03.0030.000196%Not Available
Pancreatitis relapsing07.18.01.0110.000250%Not Available
Renal atrophy20.01.06.0010.000375%Not Available
Spinal column stenosis15.10.04.003; 17.10.01.0110.000375%Not Available
Splenic vein thrombosis24.01.03.005; 01.09.02.0190.000250%Not Available
Throat cancer22.08.02.008; 16.19.02.0070.000625%Not Available
Pancreatic mass07.18.02.0070.000750%Not Available
Anaemia of malignant disease01.03.04.0030.000250%Not Available
Mechanical ileus07.13.01.0140.000250%Not Available
Carbohydrate antigen 19-9 increased13.22.01.0070.000250%Not Available
Metastases to spleen16.22.02.025; 01.09.02.0100.000375%Not Available
Adrenal mass05.01.03.0030.000500%Not Available
Insulin-requiring type 2 diabetes mellitus05.06.01.009; 14.06.01.0090.001000%Not Available
Small intestine carcinoma16.13.13.002; 07.21.01.0160.000375%Not Available
Aortic calcification24.03.04.0100.000375%Not Available
Clostridium difficile infection11.02.02.0090.000250%Not Available
Cardiac stress test abnormal13.14.02.0160.000250%Not Available
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