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Lixisenatide Side Effects

For the Consumer

Applies to lixisenatide: subcutaneous solution

Along with its needed effects, lixisenatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lixisenatide:

More common
  • Anxiety
  • bloating
  • bluish or pale skin
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • constipation
  • cough
  • darkened urine
  • depression
  • difficulty swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • fever
  • headache
  • hives, itching, redness, skin rash
  • increased hunger
  • indigestion
  • loss of appetite
  • nausea
  • nervousness
  • nightmares
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness
  • shortness of breath
  • slurred speech
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Agitation
  • decreased urine output
  • hostility
  • irritability
  • lethargy
  • muscle twitching
  • rapid weight gain
  • stupor
  • swelling of the face, ankles, or hands

Get emergency help immediately if any of the following symptoms of overdose occur while taking lixisenatide:

Symptoms of overdose
  • Diarrhea
  • loss of appetite
  • nausea or vomiting
  • stomach pain, fullness, or discomfort
  • indigestion
  • passing of gas

Some side effects of lixisenatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
Less common
  • Acid or sour stomach
  • belching
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • heartburn
  • pressure in the stomach
  • stomach discomfort, upset, or pain

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 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]

References

1. "Product Information. Adlyxin (lixisenatide)." sanofi-aventis, Bridgewater, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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.

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