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Eovist

Eovist (Gadoxetate Disodium Injection) side effects drug center

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    Liver Disease
    • 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.

    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)

    Eovist Professional Information

    SIDE EFFECTS

    The following serious but uncommon adverse reactions that have been associated with gadolinium-based contrast agents may be associated with the use of EOVIST are discussed elsewhere in the labeling:

    • Nephrogenic systemic fibrosis [see WARNINGS AND PRECAUTIONS]
    • Hypersensitivity reactions [see 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 data described below reflect EOVIST exposure in 1989 subjects who received a dose that ranged from 0.003 to 0.5 mmol/kg body weight; the majority (n=1581) received the recommended dose of 0.025 mmol/kg body weight. Overall, 59% of the subjects were men and the ethnic distribution was 64 % Caucasian, 22% Asian, 3 % Hispanic, 2% Black, and 0.5% subjects of other ethnic groups. The average age was 57.4 years (range from 19 to 84 years).

    Overall, 4.3% of subjects reported one or more adverse reactions during a follow-up period that for most subjects, extended 24 hours after EOVIST administration.

    The adverse reactions were predominantly of mild to moderate severity.

    The most frequent (≥0.5%) adverse reactions associated with the use of EOVIST are nausea, headache, feeling hot, dizziness, and back pain.

    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.

    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 treated with EOVIST at the recommended dose of 0.025 mmol/kg body weight 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 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 post-marketing 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

    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.