Januvia Side Effects
Generic name: sitagliptin
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]
Frequently asked questions
- When is the best time to take Januvia?
- How long does it take for Januvia to work?
- Does Januvia cause weight gain or loss?
- What is Januvia used for and how does it work?
- Can Januvia and Invokana be taken together?
- Can Victoza and Januvia be used together?
More about Januvia (sitagliptin)
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Januvia (sitagliptin)." Merck & Co., Inc (2006):
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf" (2015):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
