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)
Failure to thrive14.03.02.008; 18.04.01.003; 19.07.05.0010.000106%-
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.0040.000133%
Feeling abnormal08.01.09.014---
Feeling jittery08.01.09.0160.000143%-
Flank pain08.01.08.007; 15.03.04.003; 20.02.03.0060.000053%
Flatulence07.01.04.0020.000456%
Fluid retention14.05.06.002; 20.01.02.0030.000159%-
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Food poisoning07.11.01.007; 11.07.02.001; 12.03.01.024---
Fungal skin infection11.03.05.002; 23.11.03.006---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.000833%
Gallbladder disorder09.03.02.0010.000106%-
Gastric cancer07.21.02.001; 16.13.03.0010.000159%-
Gastric ulcer07.04.03.0020.000080%
Gastritis07.08.02.0010.000292%
Gastritis erosive07.04.03.0030.000053%-
Gastrooesophageal reflux disease07.02.02.0030.001258%
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.0010.000398%-
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.0090.000478%-
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.0070.000186%
Glaucoma06.03.01.0020.000292%
Goitre05.02.01.001; 14.11.01.0080.000080%-
Gout14.09.01.001; 15.01.06.0010.000265%-
Granuloma08.01.05.001; 23.03.15.0010.000133%-
Haemangioma of liver09.04.01.003; 16.06.01.003; 24.03.06.0060.000080%-
Haematemesis07.12.02.002; 24.07.02.0110.000186%-
Haematochezia07.12.02.003; 24.07.02.0120.000186%-
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ADReCS-Target
Drug Name ADR Term Target
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