Prescription medicine
Gadoxetate Brand names: Eovist
Gadoxetate (Eovist) is a prescription medicine with an FDA approval on record since 2008. No generic is listed in FDA's NDC Directory.
- 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 NDA 22090 record on Drugs@FDA; every gadoxetate label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK ASSOCIATED WITH INTRATHECAL.
USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of EOVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ]. […]
Used for
From the label: indications and usageEOVIST 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.
Forms and strengths
- 181.43 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- July 3, 2008 Eovist, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 440 through July 30, 2026
What is gadoxetate used for?
From the label: indications and usageEOVIST 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. EOVIST is a gadolinium-based contrast agent 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 pharmacologic class: Gadolinium-based Contrast Agent.
Source: FDA drug label (EOVIST), 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 patient leaflet for gadoxetate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EOVIST?GBCAs like EOVIST may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if EOVIST is safe and effective with intrathecal use. EOVIST is not approved for this use. EOVIST contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. At equivalent doses, the amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after gadodiamide than after gadoxetate disodium, or gadobenate dimeglumine. Gadolinium stays in the body the least after gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive EOVIST.
Source: FDA drug label (EOVIST), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 6218b1e1-cbc3-4c14-bec7-528ac163a561), via openFDA; the full label on DailyMed
Is there a generic for gadoxetate (Eovist)?
No generic gadoxetate is approved (Drugs@FDA, October 8, 2026).
- 2008 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gadoxetate label say about other medicines?
The gadoxetate label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadoxetate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Gadobenate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadodiamide | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. |
| Gadopiclenol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadoterate | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Gadoteridol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. |
| Naproxen | warnings and precautions | Report any diagnosis of NSF following EOVIST administration to Bayer HealthCare (1-888-842-2937) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |
Source: FDA drug label (EOVIST), 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 for gadoxetate?
The FDA Adverse Event Reporting System holds 440 reports that list gadoxetate among the medicines taken, through July 30, 2026, 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gadolinium-based contrast agents
- the pharmacologic class, with prices and generics
- Gadoxetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other