Insulin detemir Side Effects
Applies to insulin detemir: subcutaneous solution.
Serious side effects of Insulin detemir
Along with its needed effects, insulin detemir 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 detemir:
Incidence not known
- Anxiety
- blurred vision
- chest tightness
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- depression
- difficulty swallowing
- dizziness
- fast heartbeat
- fever
- headache
- hives, itching, or skin rash
- hoarseness
- increased hunger
- irritation
- joint pain
- nausea
- nightmares
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- seizures
- shakiness
- slurred speech
- stiffness or swelling
- swelling of the eyelids, face, lips, hands, or feet
- trouble breathing
- unusual tiredness or weakness
Other side effects of Insulin detemir
Some side effects of insulin detemir 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:
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
Common (1% to 10%): Injection site reactions
Uncommon (0.1% to 1%): Injection site pain[Ref]
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]
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
Insulin may cause sodium retention and edema, especially as metabolic control is improving.[Ref]
Uncommon (0.1% to 1%): Peripheral edema[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
Very common (10% or more): Influenza-like illness (up to 13%)
Common (1% to 10%): Viral infection
Frequency not reported: Antibody development[Ref]
In phase 3 trials, antibody development with no apparent impact on glycemic control was observed.[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
Very common (10% or more): Headache (up to 31%)
Common (1% to 10%): Migraine, dizziness
Rare (less than 0.1%): Painful peripheral neuropathy[Ref]
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]
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]
Frequently asked questions
More about insulin detemir
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- Reviews (74)
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- During pregnancy
- Drug class: insulin
Patient resources
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References
1. (2005) "Product Information. Levemir (insulin detemir)." Novo Nordisk Pharmaceuticals Inc
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. "Multum Information Services, Inc. Expert Review Panel"
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.