Eovist
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Eovist
Eovist Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Eovist in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some of the side effects of gadoxetate can occur up to several days after you have received the medication.
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
- swelling, irritation, or skin changes where the injection was given.
Less serious side effects may include:
- headache;
- dizziness;
- changes in your sense of taste or smell;
- nausea, vomiting;
- mild itching of your skin or eyes;
- flushing (warmth, redness, or tingly feeling);
- feeling unusually hot; or
- cold feeling, pain, or mild burning around the IV needle when the medicine is injected.
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) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Eovist FDA Prescribing Information: Side Effects
(Adverse Reactions)
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
- Hypersensitivity/anaphylactoid reactions including shock, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough and pallor [see WARNINGS AND PRECAUTIONS].
- Tachycardia
- Restlessness
Read the entire FDA prescribing information for Eovist (Gadoxetate Disodium Injection) »
Additional Eovist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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