Insulin degludec Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 8, 2023.

Applies to insulin degludec: subcutaneous solution.

Serious side effects of Insulin degludec

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:

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
• 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

Other side effects of Insulin degludec

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

• 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

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

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]

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Further information

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.

Medical Disclaimer