Januvia Side Effects
Generic Name: sitagliptin
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.
For the Consumer
Applies to sitagliptin: oral tablet
Side effects requiring immediate medical attention
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:
- blurred vision
- cold sweats
- cool, pale skin
- fast heartbeat
- increased hunger
- loss of consciousness
- slurred speech
- unusual tiredness or weakness
Incidence not known
- Blistering, peeling, loosening of the skin
- hives or welts, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- redness of the skin
- severe joint pain
- sores, ulcers, or white spots in the mouth or on the lips
Side effects not requiring immediate medical attention
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:
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- muscle aches
- sore throat
- stuffy or runny nose
- stomach pain
For Healthcare Professionals
Applies to sitagliptin: oral tablet
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%): Nasopharyngitis, upper respiratory infection, pharyngitis,
Postmarketing reports: Interstitial lung disease[Ref]
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]
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]
Common (1% to 10%): Hypertension[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Januvia (sitagliptin)." Merck & Company Inc, West Point, PA.
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: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):
Frequently asked questions
- When is the best time to take Januvia?
- Does Januvia cause weight gain or loss?
- How long does it take for Januvia to work?
- What is Januvia used for and how does it work?
- Can Januvia and Invokana be taken together?
- Can Victoza and Januvia be used together?
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.
More about Januvia (sitagliptin)
- During Pregnancy or Breastfeeding
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 109 Reviews
- Drug class: dipeptidyl peptidase 4 inhibitors
- FDA Alerts (3)
- FDA Approval History