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.
The most frequently reported adverse reactions were nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.[Ref]
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]
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]
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]
Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence[Ref]
Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Tachycardia[Ref]
Common (1% to 10%): Cystitis[Ref]
Common (1% to 10%): Injection site reactions including pain, pruritus, erythema[Ref]
Common (1% to 10%): Back pain[Ref]
Common (1% to 10%): Viral infection[Ref]
Common (1% to 10%): Influenza, upper respiratory tract infection[Ref]
Uncommon (0.1% to 1%): Urticaria[Ref]
Uncommon (0.1% to 1%): Anaphylactic reaction, angioedema, pruritus[Ref]
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?
More about lixisenatide
- Check interactions
- Dosage information
- During pregnancy
- Drug class: incretin mimetics
- En español
Related treatment guides
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Adlyxin (lixisenatide)." sanofi-aventis (2016):
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.