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Gadobutrol Side Effects

For the Consumer

Applies to gadobutrol: intravenous solution

Warning

Intravenous route (Solution)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF is greatest in patients with acute kidney injury or chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2). Evaluate patients for acute kidney injury or other conditions which may reduce renal function. Patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes) should have their estimate the glomerular filtration rate (GFR) determined through laboratory testing. Do not exceed the recommended gadobutrol dose in patients at highest risk for NSF. Allow sufficient time for the drug to be eliminated by the body prior to subsequent doses.

Along with its needed effects, gadobutrol 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 or nurse immediately if any of the following side effects occur while taking gadobutrol:

Rare

  • Bleeding, blistering, burning, coldness, discoloration of the 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
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • general feeling of discomfort or illness
  • hives or welts, itching, or skin rash
  • loss of consciousness
  • paleness of the skin
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • seizures
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness

Incidence Not Known

  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • burning sensation
  • burning, dry, or itching eyes
  • chest pain
  • cough
  • decreased or uncontrolled urination
  • deep bone pain
  • difficulty with swallowing
  • discharge or excessive tearing
  • hoarseness
  • increased sweating
  • lack or loss of strength
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • muscle stiffness or weakness
  • no blood pressure or pulse
  • no breathing
  • noisy breathing
  • numbness, tingling, pain, or weakness in the hands or feet
  • paralysis or severe weakness of the legs
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches
  • slow or irregular breathing
  • sneezing
  • stiff joints or trouble moving
  • stopping of the heart
  • swelling of the mouth or throat
  • uncontrolled bowel movements
  • uncontrolled movements of the body

Some side effects of gadobutrol 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:

Less Common

Rare

  • Change in sense of smell
  • change in taste
  • dizziness
  • dry mouth
  • feeling hot or cold
  • loss of taste
  • unusually warm skin
  • vomiting

For Healthcare Professionals

Applies to gadobutrol: intravenous solution

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity/anaphylactoid reaction[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness, paresthesia, dysgeusia

Rare (less than 0.1%): Loss of consciousness, convulsion, parosmia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Vomiting

Rare (less than 0.1%): Dry mouth[Ref]

Dermatologic

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Vomiting

Rare (less than 0.1%): Dry mouth[Ref]

Cardiovascular

Rare (less than 0.1%): Tachycardia, palpitation, pallor

Postmarketing reports: Cardiac arrest[Ref]

Respiratory

Respiratory side effects have included dyspnea.[Ref]

Local

Uncommon (0.1% to 1%): Injection site reactions[Ref]

Ocular

Very rare (less than 0.01%): Eyelid edema[Ref]

Other

Uncommon (0.1% to 1%): Feeling hot

Rare (less than 0.1%): Malaise, feeling cold[Ref]

General

The most common adverse reactions were headache, nausea, and dizziness.[Ref]

References

1. "Product Information. Gadavist (gadobutrol)." Bayer Pharmaceutical Inc, West Haven, CT.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. 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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