Quick answers
- What is Gadoxetate disodium used for?
- The FDA-approved label (Eovist, Bayer HealthCare Pharmaceuticals Inc., March 2, 2026) says: “EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gadoxetate disodium have a boxed warning?
- Yes. The FDA label for Eovist has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gadoxetate disodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gadoxetate disodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gadoxetate disodium?
- 1 company lists prescription products of Gadoxetate disodium in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..
What Gadoxetate disodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. …
— FDA label: Eovist, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Eovist |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022090 EOVIST | Bayer Hlthcare | July 3, 2008 | 18, latest February 13, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 6218b1e1-cbc3-4c14-bec7-528ac163a561 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA022090 |
| Active ingredients (FDA) | GADOXETATE DISODIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Eovist, Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →