Note: This document contains side effect information about sitagliptin. Some dosage forms listed on this page may not apply to the brand name Januvia.
Applies to sitagliptin: oral tablets.
Side effects include:
Sitagliptin (the active ingredient contained in Januvia) monotherapy or add-on therapy with metformin and/or a thiazolidinedione or glimepiride and more commonly than with placebo: Nasopharyngitis, upper respiratory tract infection, peripheral edema, headache.
Sitagliptin administered concomitantly with ertugliflozin and more commonly than with placebo: Adverse effects similar in type and incidence to those reported with ertugliflozin alone.
Sitagliptin administered concomitantly with metformin and more commonly than with placebo: Diarrhea, upper respiratory infection, headache.
Sitagliptin administered concomitantly with metformin and glimepiride and more commonly than with placebo: Hypoglycemia, headache.
Sitagliptin administered concomitantly with insulin and more commonly than with placebo: Hypoglycemia.
For Healthcare Professionals
Applies to sitagliptin: oral tablet.
Metabolic
Common (1% to 10%): Hypoglycemia (when used in combination with insulin or sulfonylurea)[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain, nausea, diarrhea, constipation, gastroenteritis
Postmarketing reports: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, vomiting, mouth ulceration, stomatitis, constipation[Ref]
In a pooled analysis of 19 trials (sitagliptin 100 mg/day, n=5429; active control or placebo, n=4817), the incidence of acute pancreatitis was in 0.1 per 100 patient-years in each group (4 patients in each group)[Ref]
Respiratory
Common (1% to 10%): Nasopharyngitis, upper respiratory infection, pharyngitis,
Postmarketing reports: Interstitial lung disease[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness[Ref]
Hypersensitivity
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with this drug. Reactions have occurred within the first 3 months of therapy initiation, with some reports occurring after the first dose.[Ref]
Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome[Ref]
Hepatic
Postmarketing reports: Hepatic enzyme elevations[Ref]
Renal
There have been postmarketing reports of worsening renal function, including acute renal failure, sometime requiring dialysis. A subset of these reports involved patients with renal insufficiency, some who were prescribed inappropriate doses of this drug. With drug discontinuation, supportive treatment and discontinuation of potentially causative agents, a return to baseline levels of renal insufficiency occurred.[Ref]
Postmarketing reports: Worsening renal function[Ref]
Musculoskeletal
Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitors. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy. In 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin (the active ingredient contained in Januvia) had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]
Postmarketing reports: Arthralgia, myalgia, extremity pain, back pain, osteoarthritis, rhabdomyolysis, severe and disabling arthralgia[Ref]
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Dermatologic
Postmarketing reports: Pruritus, bullous pemphigoid[Ref]
General
The most commonly reported adverse events included upper respiratory tract infection, nasopharyngitis, and headache. As add-on to insulin studies, hypoglycemia was commonly reported.[Ref]
