Eovist Side Effects

Please note - some side effects for Eovist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Eovist Side Effects - for the Professional

Eovist

Nephrogenic systemic fibrosis and hypersensitivity reactions are very uncommon but serious reactions that have been associated with gadolinium-based contrast agents may be associated with the use of Eovist [see Warnings and Precautions (5.1, 5.2)].

Clinical Trials Experience

The data described below reflect Eovist exposure in 1755 adult subjects who received a dose that ranged from 0.003 to 0.5 mmol/kg body weight; the majority (n=1365) received the recommended dose of 0.025 mmol/kg body weight. Overall, 59% of the subjects were men and the ethnic distribution was 72% Caucasian, 12% Asian, 3% Hispanic, 2% Black, and 0.6% patients of other ethnic groups. The average age was 58 years (range from 19 to 84 years).

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Overall, 4.3% of subjects reported one or more adverse reactions during a follow-up period that, for most subjects, extended over 24 hours after Eovist administration. The adverse reactions were predominantly of mild to moderate severity. Serious adverse events were reported among six patients and were attributed to underlying conditions or non-MRI procedures. All serious events occurred more than 10 hours following Eovist administration.

Table 1 lists adverse reactions that occurred in ≥0.1% subjects treated with Eovist at the recommended dose of 0.025 mmol/kg body weight.

Adverse reactions that occurred with a frequency of <0.1% in subjects treated with Eovist at the recommended dose of 0.025 mmol/kg body weight include: paresthesia, chest pain, back pain, vertigo, tremor, akathisia, bundle branch block, palpitation, dry mouth, oral discomfort, salivary hypersecretion, maculopapular rash, hyperhidrosis, chills, discomfort, fatigue and malaise.

Elevation of serum iron values and serum bilirubin laboratory values were reported in less than 1% of patients after administration of Eovist. The values did not exceed more than 2–3 times the baseline values and returned to baseline within 1 to 4 days without other signs or symptoms of other abnormalities.

Postmarketing Experience

The following additional adverse reactions have been reported during the postmarketing use of Eovist. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reports were for anaphylactoid reactions including shock, tachycardia and restlessness.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included chest pain, bundle branch block, increased blood pressure, and flushing.

Nervous system

Nervous system side effects have included headache, akathisia, dizziness, parosmia, vertigo, tremor, akathisia, and dysgeusia.

Respiratory

Respiratory side effects have included dyspnea and respiratory distress.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, oral discomfort, salivary hypersecretion, nausea, and vomiting.

General

General side effects have included feeling hot, chills, discomfort, fatigue and malaise.

Dermatologic

Dermatologic side effects have included maculopapular rash, hyperhidrosis, rash, and pruritus.

Local

Local side effects have included injection site reactions (pain, burning, coldness, extravasation).

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