Januvia Side Effects

Generic name: sitagliptin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 11, 2024.

Note: This document provides detailed information about Januvia Side Effects associated with sitagliptin. Some dosage forms listed on this page may not apply specifically to the brand name Januvia.

Applies to sitagliptin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loose skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.

This medicine may cause kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Januvia

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:

Serious side effects of Januvia

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:

For healthcare professionals

Applies to sitagliptin: oral liquid, oral tablet.

General adverse events

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]

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

• Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome^[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]

Hepatic

• Postmarketing reports: Hepatic enzyme elevations^[Ref]

Renal

• Postmarketing reports: Worsening renal function^[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]

Musculoskeletal

• Postmarketing reports: Arthralgia, myalgia, extremity pain, back pain, osteoarthritis, rhabdomyolysis, severe and disabling arthralgia^[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]

Cardiovascular

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

Dermatologic

• Postmarketing reports: Pruritus, bullous pemphigoid^[Ref]

Metabolic

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

See also:

Frequently asked questions

• What is Januvia used for and how does it work?
• Can Januvia and Invokana be taken together?
• When is the best time to take Januvia?
• How long does it take for Januvia to work?
• Does Januvia cause weight gain or loss?
• Can Victoza and Januvia be used together?

Further information

Januvia side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer