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Sitagliptin Side Effects

It is possible that some side effects of sitagliptin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sitagliptin: oral tablet

As well as its needed effects, sitagliptin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sitagliptin, check with your doctor immediately:

Less common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of consciousness
  • nausea
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness

Some sitagliptin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Body aches or pain
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose
Less common
  • Abdominal or stomach pain
  • diarrhea

For Healthcare Professionals

Applies to sitagliptin: oral tablet


Common (1% to 10%): Hypoglycemia (when used in combination with insulin or sulfonylurea)[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]

Common (1% to 10%): Abdominal pain, nausea, diarrhea, constipation, gastroenteritis
Postmarketing reports: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, vomiting[Ref]


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]


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]


Postmarketing reports: Hepatic enzyme elevations[Ref]


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]


Postmarketing reports: Arthralgia, myalgia, extremity pain, back pain, osteoarthritis[Ref]

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]


Common (1% to 10%): Hypertension[Ref]


Postmarketing reports: Pruritus[Ref]


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]


1. "Product Information. Januvia (sitagliptin)." Merck & Company Inc, West Point, PA.

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

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. Available from: URL:" ([2015, Aug 28]):

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