Gadavist Side Effects

Generic name: gadobutrol

Note: This document contains side effect information about gadobutrol. Some of the dosage forms listed on this page may not apply to the brand name Gadavist.

Some side effects of Gadavist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to gadobutrol: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking gadobutrol (the active ingredient contained in Gadavist) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects of gadobutrol may occur up to several days after injection.

Call your doctor at once if you have a serious side effect such as:

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite;

• swelling, weight gain, feeling short of breath;

• seizure (convulsions);

• breathing problems;

• pounding heartbeats or fluttering in your chest; or

• severe pain, burning, or irritation around the IV needle.

Less serious side effects of gadobutrol may include:

• headache, dizziness;

• dry mouth, nausea, vomiting;

• feeling unusually hot;

• unusual or unpleasant taste in your mouth;

• numbness or tingly feeling;

• mild itching or rash; or

• cold feeling, warmth, pain, or burning where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to gadobutrol: intravenous solution

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid shock, circulatory collapse, increased blood pressure, chest pain, respiratory arrest, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, face edema, angioedema, conjunctivitis, eyelid edema, hyperhidrosis, cough, sneezing, and burning sensation.

Nervous system

Nervous system side effects have included headache, dysgeusia, parosmia, dizziness, paresthesia, loss of consciousness, and convulsions.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting and dry mouth.

Dermatologic

Dermatologic side effects have included erythema, rash (including generalized, macular, papular, pruritic) and pruritus.

Cardiovascular

Cardiovascular side effects have included hypotension, flushing, pallor, tachycardia, palpitation, and cardiac arrest

Renal

Renal side effects have included nephrogenic systemic fibrosis (NSF).

Respiratory

Respiratory side effects have included dyspnea.

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