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Insulin degludec Side Effects

For the Consumer

Applies to insulin degludec: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by insulin degludec. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with insulin degludec may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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 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.

Not all side effects for insulin degludec may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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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