Lixisenatide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 16, 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 adverse events

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

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

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]

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]

See also:

Frequently asked questions

• Soliqua vs Lantus: What’s the difference between them?
• What is the difference between Soliqua and Xultophy?
• How often do you need to inject Adlyxin?

Further information

Lixisenatide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer