Gadoversetamide Side Effects

Some side effects of gadoversetamide 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 gadoversetamide: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking gadoversetamide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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; or

• fast, uneven heart rate.

Less serious side effects of gadoversetamide may include:

• headache, dizziness;

• nausea, diarrhea;

• flushing (warmth, redness, or tingly feeling);

• unusual or unpleasant taste in your mouth;

• numbness, burning pain, or tingling in your hands or feet; or

• cold feeling, warmth, pain, bruising, swelling, 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 gadoversetamide: intravenous solution

Nervous system

Nervous system side effects have included headache, dizziness, paresthesia, agitation, anxiety, confusion, depersonalization, dystonia, hallucinations, hypertonia, hypesthesia, nervousness, somnolence, tremor, hyperacusis, parosmia, tinnitus, seizure, and vertigo.

Cardiovascular

Cardiovascular side effects have included vasodilatation, arrhythmia, chest pain, hypertension, hypotension, pallor, palpitation, syncope, tachycardia, and vasospasm.

Gastrointestinal

Gastrointestinal side effects have included taste perversion, nausea, anorexia, increased appetite, constipation, dry mouth, dysphagia, eructation, flatulence, increased salivation, thirst, and vomiting.

Ocular

Ocular side effects have included diplopia, amblyopia, and conjunctivitis.

Respiratory

Respiratory side effects have included asthma, cough, dyspnea, epistaxis, hemoptysis, laryngismus, pharyngitis, sinusitis, and voice alteration.

Local

Local side effects have included application site reaction, injection site edema and inflammation.

Dermatologic

Dermatologic side effects have included erythema multiforme, pruritus, macular papular rash, vesicullous bullous rash, skin dry, thrombophlebitis, and urticaria.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, leg cramps, myalgia, myasthenia, and spasm.

Genitourinary

Genitourinary side effects have included dysuria, oliguria, and urine frequency.

Metabolic

Metabolic side effects have included increased creatinine, edema, hypercalcemia, hyperglycemia, hypoglycemia, and hyponatremia.

Hematologic

Hematologic side effects have included thrombocytopenia.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction, facial edema, fever, flu-like syndrome, malaise, mucous membrane discharge, neck rigidity, neck pain, pelvic pain, and increased sweating.

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