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Sitagliptin Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 21, 2021.

Applies to sitagliptin: oral tablets.

Side effects include:

Sitagliptin 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 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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Januvia (sitagliptin)." Merck & Company 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.