Insulin detemir Side Effects

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

For the Consumer

Applies to insulin detemir: subcutaneous solution

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

You should check with your doctor immediately if any of these side effects occur when taking insulin detemir:

Incidence not known
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • hives
  • hoarseness
  • increased hunger
  • irritation
  • itching
  • joint pain
  • nausea
  • nightmares
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • seizures
  • shakiness
  • skin rash
  • slurred speech
  • stiffness or swelling
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Some of the side effects that can occur with insulin detemir 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:

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
  • decrease in the amount of urine
  • noisy, rattling breathing
  • redistribution or accumulation of body fat
  • swelling of the fingers, hands, feet, or lower legs
  • trouble breathing at rest
  • weight gain

For Healthcare Professionals

Applies to insulin detemir: subcutaneous solution

General

Adverse reactions associated with insulin detemir include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Metabolic

Severe hypoglycemia defined as third party intervention, occurred in approximately 6% of patients receiving insulin detemir in clinical trials. Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.[Ref]

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

Local

Injection site reactions seem to occur more frequently with insulin detemir than with human insulin products. Reactions have included pain, redness, hives, inflammation, bruising, swelling, and itching at the injection site. Most injection site reactions have been minor and transitory, disappearing in a few days to a few weeks, even with continued treatment.[Ref]

Common (1% to 10%): Injection site reactions
Uncommon (0.1% to 1%): Injection site pain[Ref]

Hypersensitivity

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.

Allergic reactions and potentially allergic reactions were reported more frequently in 3 clinical studies with subjects receiving combination oral antidiabetic agents compared with the frequency across all studies (2.2% versus 0.1% to 1%).[Ref]

Uncommon (0.1% to 1%): Allergic reactions[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Peripheral edema[Ref]

Insulin may cause sodium retention and edema, especially as metabolic control is improving.[Ref]

Ocular

Frequency not reported: Refraction disorder, worsening of diabetic retinopathy[Ref]

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk of diabetic retinopathy.[Ref]

Dermatologic

Common (1% to 10%): Lipohypertrophy
Uncommon (0.1% to 1%): Lipoatrophy
Postmarketing reports: Rash urticaria[Ref]

Immunologic

In phase 3 trials, antibody development with no apparent impact on glycemic control was observed.[Ref]

Very common (10% or more): Influenza-like illness (up to 13%)
Common (1% to 10%): Viral infection
Frequency not reported: Antibody development[Ref]

Other

Common (1% to 10%): Pyrexia, fatigue[Ref]

Gastrointestinal

Very common (10% or more): Gastroenteritis (up to 16%), abdominal pain (up to 13%)
Common (1% to 10%): Nausea, vomiting, toothache[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Nervous system

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.[Ref]

Very common (10% or more): Headache (up to 31%)
Common (1% to 10%): Migraine, dizziness
Rare (less than 0.1%): Painful peripheral neuropathy[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 35%), pharyngitis (up to 17%)
Common (1% to 10%): Bronchitis, cough, rhinitis, sinusitis[Ref]

References

1. "Product Information. Levemir (insulin detemir)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Multum Information Services, Inc. Expert Review Panel"

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