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.
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
- 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
Other 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:
Less common
- Headache
- nausea
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
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]
General
The most common adverse reactions were headache, nausea, and dizziness.[Ref]
