Note: This document contains side effect information about insulin detemir. Some dosage forms listed on this page may not apply to the brand name Levemir.
Summary
Common side effects of Levemir include: severe hypoglycemia. Continue reading for a comprehensive list of adverse effects.
Applies to insulin detemir: parenteral injection.
Side effects include:
Hypoglycemia, allergic reactions, pruritus, rash, injection site reactions, lipodystrophy, peripheral edema, weight gain.
Adults with type 1 or type 2 diabetes mellitus: Upper respiratory tract infection, headache, pharyngitis, influenza-like illness, abdominal pain, back pain, gastroenteritis, bronchitis.
Pregnant women with type 1 diabetes mellitus: nasopharyngitis, headache, anemia, diarrhea, preeclampsia, urinary tract infection, gastroenteritis, upper abdominal pain, vomiting, spontaneous abortion, abdominal pain, oropharyngeal pain.
Children and adolescents with type 1 diabetes mellitus: Upper respiratory tract infection, headache, pharyngitis, gastroenteritis, influenza-like illness, abdominal pain, pyrexia, cough, viral infection, nausea, rhinitis, vomiting.
For Healthcare Professionals
Applies to insulin detemir: subcutaneous solution.
General
Adverse reactions associated with insulin detemir (the active ingredient contained in Levemir) 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 (the active ingredient contained in Levemir) 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 (the active ingredient contained in Levemir) 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
Insulin may cause sodium retention and edema, especially as metabolic control is improving.[Ref]
Uncommon (0.1% to 1%): Peripheral edema[Ref]
Ocular
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]
Frequency not reported: Refraction disorder, worsening 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
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]
