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
Musculoskeletal
Other
- Common (1% to 10%): Viral infection[Ref]
Respiratory
Dermatologic
Hypersensitivity
- Uncommon (0.1% to 1%): Anaphylactic reaction, angioedema, pruritus[Ref]
See also:
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References
1. Cerner Multum, Inc. "Australian Product Information."
2. (2016) "Product Information. Adlyxin (lixisenatide)." sanofi-aventis
Frequently asked questions
- Soliqua vs Lantus: What’s the difference between them?
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- How often do you need to inject Adlyxin?
More about lixisenatide
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- During pregnancy
- Drug class: GLP-1 Agonists (Incretin Mimetics)
- Breastfeeding
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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.