Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sitagliptin phosphate
Drug ID BADD_D02030
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 D06645; D12294
MeSH ID D000068900
PubChem ID 6451150
TTD Drug ID D0U2JP
NDC Product Code 48087-0078; 60312-0107; 60312-0109; 67317-0113; 12666-0013; 58175-0620; 50370-0026; 65344-0031; 60312-0108; 49711-1519; 66039-873; 67317-0114; 15894-0018; 66651-917; 67317-0056; 65727-078; 73309-144; 48087-0154; 67835-0022; 71796-010; 75945-020; 48087-0155; 50370-0027; 59651-231; 65015-766; 69037-0022; 82608-006
UNII TS63EW8X6F
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 C16H18F6N5O5P
CAS Registry Number 654671-78-0
SMILES C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)CC(CC3=CC(=C(C=C3F)F)F)N.OP(=O)(O)O
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)
Abdominal pain07.01.05.002--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Constipation07.02.02.001--
Cutaneous vasculitis10.02.02.003; 24.12.04.008; 23.06.02.001--Not Available
Diarrhoea07.02.01.001--
Headache17.14.01.001--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pancreatitis acute07.18.01.002--Not Available
Rash23.03.13.001--Not Available
Skin exfoliation23.03.07.003--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
White blood cell count increased13.01.06.013--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Renal impairment20.01.03.010--Not Available
Acute kidney injury20.01.03.016--
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