Gadobutrol Side Effects
Medically reviewed by Drugs.com. Last updated on Jul 31, 2024.
Applies to gadobutrol: intravenous solution.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your or your child's progress while you are receiving this medicine and during the MRI or MRA scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Check with your doctor or nurse right away if you or your child have burning or itching of the skin, deep bone pain in the hips or ribs, joint stiffness, a limited range of motion in the arms and legs, muscle weakness, red or dark patches on the skin of the arms or legs, or skin swelling, hardening, or tightening within the first few days or weeks after you receive this medicine. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble with breathing after receiving the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin, liver, kidney, spleen) for a long time (several months to years). Talk to your doctor if you have concerns.
This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased if you or your child are receiving high doses of gadobutrol.
Tell your doctor right away if you or your child have burning pain, feeling of warmth or coldness, redness or swelling at the injection site.
Common side effects of gadobutrol
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:
Rare side effects
Serious side effects of gadobutrol
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 side effects
- 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
For healthcare professionals
Applies to gadobutrol: intravenous solution.
General adverse events
The most common adverse reactions were headache, nausea, and dizziness.[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
- Uncommon (0.1% to 1%): Rash, pruritus, erythema
- Very rare (less than 0.01%): Face edema
- Postmarketing reports: Nephrogenic systemic fibrosis[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]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity/anaphylactoid reaction[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2011) "Product Information. Gadavist (gadobutrol)." Bayer Pharmaceutical Inc
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Further information
Gadobutrol 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.