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)
Hypervolaemia02.05.04.019; 14.05.06.0030.000106%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoalbuminaemia14.10.01.002; 09.01.02.0030.000133%
Hypocalcaemia14.04.01.0040.000106%
Hypoglycaemia14.06.03.001; 05.06.03.0010.001868%
Hypoglycaemic coma14.06.03.004; 05.06.03.004; 17.02.09.0050.000212%Not Available
Hypokalaemia14.05.03.0020.000425%
Hypomagnesaemia14.04.02.0010.000080%
Hyponatraemia14.05.04.0020.000425%
Hypophosphataemia14.04.03.0010.000106%
Hypothermia12.05.03.001; 08.05.01.0030.000053%
Hypothyroidism05.02.03.001; 14.11.01.0120.000504%
Hypovolaemia14.05.05.0020.000133%Not Available
Ileus07.13.01.0010.000133%
Immune system disorder10.02.01.001--Not Available
Impaired gastric emptying07.02.02.0040.000196%
Impaired healing08.03.02.0010.000143%Not Available
Increased appetite14.03.01.003; 08.01.09.0270.000387%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.0050.000106%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.000287%
Inguinal hernia07.16.02.0010.000159%Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.0010.000117%Not Available
Insomnia19.02.01.002; 17.15.03.0020.001231%
Intermittent claudication24.04.03.0010.000053%Not Available
Interstitial lung disease10.02.01.033; 22.01.02.0030.000807%Not Available
Intestinal obstruction07.13.01.0020.000239%Not Available
Intestinal perforation07.04.06.0020.000053%Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.0020.000159%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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