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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.

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:

More common side effects

  • body aches or pain
  • diarrhea
  • dry mouth
  • ear congestion
  • fever
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • stomach pain

Incidence not known

  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • redistribution or accumulation of body fat

Serious side effects of Tresiba

Along with its needed effects, insulin degludec (the active ingredient contained in Tresiba) 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:

Less common side effects

  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Incidence not known

  • anxiety
  • blurred vision
  • chest tightness
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • cough
  • decreased urine
  • depression
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast heartbeat
  • headache
  • hives, itching, or skin rash
  • increased hunger
  • increased thirst
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • loss of appetite
  • muscle pain or cramps
  • nausea
  • nightmares
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness
  • slurred speech
  • sweating
  • unusual tiredness or weakness
  • vomiting
Managing side effects (general information)

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

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

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

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

Dermatologic

Immunologic

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

Nervous system

Gastrointestinal

References

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

2. (2015) "Product Information. Tresiba FlexTouch (insulin degludec)." Novo Nordisk Pharmaceuticals Inc

Frequently asked questions

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