Eovist Side Effects Center

Last updated on RxList: 1/7/2022
Eovist Side Effects Center

What Is Eovist?

Eovist (gadoxetate disodium) is a contrast agent that produces magnetic effects and is used in combination with magnetic resonance imaging (MRI) to help diagnose certain disorders of the liver.

What Are Side Effects of Eovist?

Common side effects of Eovist include:

  • headache
  • dizziness
  • changes in your sense of taste or smell
  • unusual or unpleasant taste in your mouth
  • nausea
  • vomiting
  • mild itching of your skin or eyes
  • skin rash
  • flushing (warmth, redness, or tingly feeling)
  • feeling unusually hot, or
  • injection site reactions (cold feeling, pain, mild burning, warmth, bruising, or swelling)

Dosage for Eovist

The recommended dose of Eovist is 0.1 mL/kg body weight (0.025 mmol/kg body weight).

What Drugs, Substances, or Supplements Interact with Eovist?

Eovist may interact with rifampin or other drugs that can affect the kidneys. Tell your doctor all medications and supplements you use.

Eovist During Pregnancy or Breastfeeding

During pregnancy, Eovist should be used only if prescribed. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Eovist (gadoxetate disodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Eovist Consumer Information

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

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

Gadoxetate can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • tiredness, muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or dark patches.

Also call your doctor at once if you have:

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • swelling, irritation, or skin changes where the injection was given.

Common side effects may include:

  • headache, back pain;
  • dizziness;
  • nausea; or
  • feeling hot.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eovist (Gadoxetate Disodium Injection)

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Eovist Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Nephrogenic systemic fibrosis (NSF) [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

The adverse reactions described in this section reflect EOVIST exposure in 1,989 subjects with the majority (1,581 subjects) receiving the recommended dose. Overall, 59% of the subjects were men and the ethnic distribution was 64% Caucasian, 22% Asian, 3% Hispanic, 2% Black, and 0.5% of subjects consisted of other ethnic groups. The average age was 57 years (age range from 19 to 84 years).

Overall, 4% of subjects reported one or more adverse reactions following EOVIST administration. The most frequent (≥ 0.5%) adverse reactions associated with the use of EOVIST were nausea, headache, feeling hot, dizziness, and back pain. Adverse reactions were predominantly of mild to moderate severity.

Table 1 lists adverse reactions that occurred in ≥ 0.1% of subjects treated with EOVIST.

Table 1 Adverse Reactions

Reaction Rate (%)
n = 1581
Nausea 1.1
Headache 1.1
Feeling hot 0.8
Dizziness 0.6
Back pain 0.6
Vomiting 0.4
Blood pressure increased 0.4
Injection site reactions (pain, burning, coldness, extravasation, irritation) 0.4
Dysgeusia 0.4
Paresthesia 0.3
Flushing 0.3
Parosmia 0.3
Pruritus (generalized, eye) 0.3
Rash 0.3
Respiratory disorders (dyspnea, respiratory distress) 0.2
Fatigue 0.2
Chest pain 0.1
Vertigo 0.1
Dry mouth 0.1
Chills 0.1
Feeling abnormal 0.1

Adverse reactions that occurred with a frequency of < 0.1% in subjects who received EOVIST include: tremor, akathisia, bundle branch block, palpitation, oral discomfort, salivary hypersecretion, maculopapular rash, hyperhidrosis, discomfort, 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 3 times the baseline values and returned to baseline within 1 to 4 days.

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.

  • Hypersensitivity reactions (anaphylactic shock, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough and pallor) [see WARNINGS AND PRECAUTIONS]
  • Tachycardia
  • Restlessness
  • General Disorders and Administration Site Conditions: Adverse events with variable onset and duration have been reported after GBCA administration [see WARNINGS AND PRECAUTIONS]. These include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems.
  • Skin: Gadolinium associated plaques

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Eovist (Gadoxetate Disodium Injection)

© Eovist Patient Information is supplied by Cerner Multum, Inc. and Eovist Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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