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Tresiba Side Effects

Generic Name: insulin degludec

Note: This document contains side effect information about insulin degludec. Some of the dosage forms listed on this page may not apply to the brand name Tresiba.

For the Consumer

Applies to insulin degludec: subcutaneous solution

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
  • 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
  • chills
  • cold sweats
  • confusion
  • convulsions
  • 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 sex organs
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • nightmares
  • numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shakiness
  • slurred speech
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness

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

For Healthcare Professionals

Applies to insulin degludec: subcutaneous solution

General

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]

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

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

Local

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

Injection site reactions have included injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoluration, 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[Ref]

Immunologic

The incidence of anti-insulin degludec (the active ingredient contained in Tresiba) antibodies has not been established. The detection of antibodies is 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 medications, and underlying disease. Therefore, comparison of the incidence of antibodies may be misleading. In a study in patients with type 1 diabetes, almost 96% of patients were positive for anti-insulin antibodies at least once during the studies, including almost 90% at baseline.[Ref]

Frequency not reported: Anti-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]

References

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

2. "Product Information. Tresiba FlexTouch (insulin degludec)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Some side effects of Tresiba may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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