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
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]
Frequently asked questions
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More about lixisenatide
- Check interactions
- Compare alternatives
- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- Drug class: Incretin Mimetics (GLP-1 Agonists)
- Breastfeeding
Patient resources
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References
1. Cerner Multum, Inc. Australian Product Information.
2. Product Information. Adlyxin (lixisenatide). sanofi-aventis. 2016.
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.
