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)
Umbilical hernia07.16.03.0010.000133%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000212%
Urinary retention20.02.02.0110.000106%
Urinary tract disorder20.08.01.0010.000143%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine leiomyoma21.07.02.004; 16.04.02.0010.000133%Not Available
Varicose vein24.10.04.0010.000143%Not Available
Vasculitic rash24.12.04.026; 23.06.02.003; 10.02.02.0120.000053%Not Available
Ventricular extrasystoles02.03.04.0070.000080%Not Available
Ventricular fibrillation02.03.04.0080.000080%
Ventricular tachycardia02.03.04.0100.000053%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.0070.000743%
Visual impairment06.02.10.0130.000456%Not Available
Vitamin B12 deficiency14.12.02.0040.000053%Not Available
Vitamin D deficiency14.12.03.0030.000249%Not Available
Vomiting07.01.07.0030.002016%
Weight increased13.15.01.006--
Wheezing22.03.01.0090.000106%
Mental status changes19.07.01.0010.000223%Not Available
Tubulointerstitial nephritis20.05.02.0020.000223%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000106%Not Available
Fibromyalgia15.05.02.0020.000260%Not Available
Intestinal polyp16.05.01.002; 07.20.01.0090.000053%Not Available
Joint range of motion decreased15.01.02.0060.000053%
Tooth infection11.01.04.004; 07.09.01.004--
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.0050.000133%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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