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Lixisenatide Side Effects

For the Consumer

Applies to lixisenatide: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by lixisenatide. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

If any of the following symptoms of overdose occur while taking lixisenatide, get emergency help immediately:

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

Minor Side Effects

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

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

Not all side effects for lixisenatide may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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