Adlyxin Side Effects
Generic name: lixisenatide
Medically reviewed by Drugs.com. Last updated on Aug 16, 2024.
Note: This document provides detailed information about Adlyxin.
Applies to lixisenatide: parenteral injection Side Effects associated with lixisenatide. Some dosage forms listed on this page may not apply specifically to the brand name Adlyxin.
Applies to lixisenatide: parenteral injection.
Side effects include:
Lixisenatide: Nausea, vomiting, headache, diarrhea, dizziness, hypoglycemia.
Fixed combination of insulin glargine and lixisenatide (the active ingredient contained in Adlyxin) 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
- Very common (10% or more): Development of anti-lixisenatide (the active ingredient contained in Adlyxin) 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]
References
1. Cerner Multum, Inc. "Australian Product Information."
2. (2016) "Product Information. Adlyxin (lixisenatide)." sanofi-aventis
Frequently asked questions
- What is the difference between Soliqua and Xultophy?
- How often do you need to inject Adlyxin?
- Soliqua vs Lantus: What’s the difference between them?
More about Adlyxin (lixisenatide)
- Check interactions
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- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: Incretin Mimetics (GLP-1 Agonists)
- Breastfeeding
Patient resources
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Further information
Adlyxin 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.
Some side effects may not be reported. You may report them to the FDA.