What the label lists and what reports show
Gadoxetate side effects
Gadoxetate's FDA label: “Most common adverse reactions (incidence ≥ 0.5%) are nausea, headache, feeling hot, dizziness, and back pain.” FAERS holds 440 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (160 reports).
- No generic listed
- Boxed warning
Check it at the source: the gadoxetate FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EOVIST?See " What is the most important information I should know about EOVIST? " Allergic reactions. EOVIST can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of EOVIST include: nausea, headache, feeling hot, dizziness, and back pain. These are not all the possible side effects of EOVIST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 6218b1e1-cbc3-4c14-bec7-528ac163a561), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 0.5%) are nausea, headache, feeling hot, dizziness, and back pain.
Table 1: Adverse Reactions Reported in ≥ 0.1% of Adult Subjects who Received EOVIST in Clinical Trials
| Adverse Reaction | EOVIST n = 1,581 Rate (%) |
|---|---|
| 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥ 0.5%) are nausea, headache, feeling hot, dizziness, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-84-BAYER (1-888-842-2937) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Adverse Reactions in Adults The safety of EOVIST was evaluated in 1,989 adult subjects who received EOVIST in clinical trials. Overall, 59% of the subjects were male, and the racial and ethnic distribution was 64% White, 22% Asian, 3% Hispanic or Latino, 2% Black or African American, and 0.5% other ethnic groups. The average age was 57 years (age range from 19 to 84 years). Table 1 lists adverse reactions that occurred in ≥ 0.1% of subjects who received the recommended dose of EOVIST in clinical trials.
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 6218b1e1-cbc3-4c14-bec7-528ac163a561), via openFDA; the full label on DailyMed
What do FAERS reports show?
440 reports list gadoxetate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 29 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Gadoxetate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions