Tresiba Side Effects

Generic name: insulin degludec

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 8, 2024.

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

Applies to insulin degludec: subcutaneous solution.

Precautions

Never share insulin pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

It is very important that your doctor will want to check your progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you or your child is taking insulin degludec (the active ingredient contained in Tresiba) unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—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 that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin degludec and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin degludec can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin degludec with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

• Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, changes in insulin regimen, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
• If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you use the medicine.

This medicine may cause hypokalemia (low levels of potassium in your blood). Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

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 Tresiba

Some side effects of insulin degludec 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 Tresiba

Along with its needed effects, insulin degludec 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 insulin degludec:

For healthcare professionals

Applies to insulin degludec: subcutaneous solution.

General adverse events

The most commonly reported adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia
• Frequency not reported: Weight gain^[Ref]

Weight gain, attributed to the anabolic effects of insulin, has been reported. In 52-week clinical trials, an average weight gain of 1.8 kg and 3 kg was reported in patients with type 1 diabetes and type 2 diabetes, respectively.^[Ref]

Cardiovascular

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

In clinical trials, peripheral edema was reported in 3% and 0.9% of patients with type 1 diabetes and type 2 diabetes, respectively.^[Ref]

Local

• Common (1% to 10%): Injection site reactions^[Ref]

Injection site reactions have included injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. These reactions are usually mild and transient and disappear with continued treatment.^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching) and urticaria^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Lipodystrophy, urticaria
• Postmarketing reports: Localized cutaneous amyloidosis (at injection site)^[Ref]

Immunologic

• Frequency not reported: Anti-insulin antibodies^[Ref]

Insulin administration may cause anti-insulin antibodies to form. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. It is for these reasons, comparisons with antibodies in other studies or to other products may be misleading.

In a study of adult insulin-experienced type 1 diabetes patients, 68.9% of patients receiving this were positive at baseline for anti-insulin degludec antibodies and 12.3% of the patients developed anti-insulin degludec antibodies at least once during the study. In pediatric insulin-experienced patients with type 1 diabetes, 84.1% of those were positive at baseline for anti-insulin degludec antibodies and 5.8% of patients developed anti-insulin degludec antibodies at least once during the study. Between 96.7% and 99.7% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (23.9%), upper respiratory tract infection (11.9%)
• Common (1% to 10%): Sinusitis^[Ref]

Nervous system

• Very common (10% or more): Headache (11.8%)^[Ref]

Gastrointestinal

• Common (1% to 10%): Gastroenteritis, diarrhea^[Ref]

See also:

Frequently asked questions

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Further information

Tresiba 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