Note: This document contains side effect information about sitagliptin. Some of the dosage forms listed on this page may not apply to the brand name Januvia.
Applies to sitagliptin: oral tablet
Along with its needed effects, sitagliptin (the active ingredient contained in Januvia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sitagliptin:
Incidence not known
Some side effects of sitagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to sitagliptin: oral tablet
Common (1% to 10%): Hypoglycemia (when used in combination with insulin or sulfonylurea)
In a pooled analysis of 19 trials (sitagliptin (the active ingredient contained in Januvia) 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)
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
Common (1% to 10%): Nasopharyngitis, upper respiratory infection, pharyngitis,
Postmarketing reports: Interstitial lung disease
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
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.
Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome
Postmarketing reports: Hepatic enzyme elevations
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.
Postmarketing reports: Worsening renal function
Postmarketing reports: Arthralgia, myalgia, extremity pain, back pain, osteoarthritis, rhabdomyolysis
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 had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).
Common (1% to 10%): Hypertension
Postmarketing reports: Pruritus
The most commonly reported adverse events included upper respiratory tract infection, nasopharyngitis, and headache. As add-on to insulin studies, hypoglycemia was commonly reported.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Januvia (www.drugs.com/januvia.html).