Lixisenatide Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 20, 2023.

Applies to lixisenatide: parenteral injection.

Side effects include:

Lixisenatide: Nausea, vomiting, headache, diarrhea, dizziness, hypoglycemia.

Fixed combination of insulin glargine and lixisenatide: Hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, headache.

For Healthcare Professionals

Applies to lixisenatide: subcutaneous kit, subcutaneous solution.

General

The most frequently reported adverse reactions were nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 26.5%), vomiting (up to 10.5%)

Common (1% to 10%): Dyspepsia, diarrhea, constipation, abdominal distension, abdominal pain, upper abdominal pain

Frequency not reported: Pancreatitis^[Ref]

Gastrointestinal adverse reactions including nausea and vomiting were responsible for discontinuation of treatment in 4.3% of patients. During clinical trials, the severity of gastrointestinal adverse reactions were graded as mild, moderate or severe in 64.2%, 32.3%, and 3.5% of cases, respectively. The majority of reactions occurred during the first 3 weeks of treatment.

During clinical trials, 21 cases of pancreatitis were reported including acute pancreatitis (n=3), pancreatitis (n=12), chronic pancreatitis (n=5), and edematous pancreatitis (n=1). Of these cases, some had risk factors such as a history of cholelithiasis or alcohol abuse. Fourteen cases of pancreatitis were reported in the comparator-treated.^[Ref]

Immunologic

Pooled analysis of drug-treated patients has found that almost 70% were antibody positive at 24 weeks. Of the antibody positive patients, those with the highest antibody concentrations (greater than 100 nmol/L) had attenuated glycemic responses. Additionally, a higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients.^[Ref]

Very common (10% or more): Development of anti-lixisenatide antibodies (69.8%)^[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (in combination with a sulfonylurea and/or a basal insulin)

Common (1% to 10%): Hypoglycemia (in combination with metformin alone)^[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Dizziness, somnolence^[Ref]

Cardiovascular

Common (1% to 10%): Palpitations

Uncommon (0.1% to 1%): Tachycardia^[Ref]

Genitourinary

Common (1% to 10%): Cystitis^[Ref]

Local

Common (1% to 10%): Injection site reactions including pain, pruritus, erythema^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Other

Common (1% to 10%): Viral infection^[Ref]

Respiratory

Common (1% to 10%): Influenza, upper respiratory tract infection^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, angioedema, pruritus^[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.

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