Prescription medicine
Gadobutrol Brand names: Gadavist
Gadobutrol (Gadavist) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the gadobutrol FDA label on DailyMed (effective May 1, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 201277 record on Drugs@FDA; every gadobutrol label on DailyMed.
Highlights of the record
FDA label of May 1, 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. GADAVIST 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 GADAVIST 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 GADAVIST 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 usageGADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aor
Forms and strengths
- 604.72 mg/ml
Injection.
On the market
- Earliest approval on file
- March 14, 2011 Gadavist, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first November 17, 2022; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,851 through July 30, 2026
What is gadobutrol used for?
From the label: indications and usageGADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a […]
FDA pharmacologic class: Gadolinium-based Contrast Agent.
Source: FDA drug label (Gadavist), Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026 (SPL set bd28560f-de4d-4140-874e-31df823f4dbb), via openFDA; the full label on DailyMed
What does the patient leaflet for gadobutrol 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 GADAVIST?GBCAs like GADAVIST 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 GADAVIST is safe and effective with intrathecal use. GADAVIST is not approved for this use. GADAVIST 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. There are different GBCAs that can be used for your MRI exam. 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 GADAVIST.
Source: FDA drug label (Gadavist), Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026 (SPL set bd28560f-de4d-4140-874e-31df823f4dbb), via openFDA; the full label on DailyMed
Is there a generic for gadobutrol (Gadavist)?
The FDA approved the first generic gadobutrol on November 17, 2022. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists gadobutrol from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2011 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is gadobutrol in shortage?
No gadobutrol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated June 30, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
| Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 30, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the gadobutrol label say about other medicines?
The gadobutrol label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadobutrol. 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. |
| 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. |
| Gadoxetate | 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. |
| Naproxen | warnings and precautions | Report any diagnosis of NSF following GADAVIST administration to Bayer Healthcare (1-888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch). |
Source: FDA drug label (Gadavist), Bayer HealthCare Pharmaceuticals Inc., effective May 1, 2026 (SPL set bd28560f-de4d-4140-874e-31df823f4dbb), via openFDA; the full label on DailyMed
What do FAERS reports show for gadobutrol?
The FDA Adverse Event Reporting System holds 4,851 reports that list gadobutrol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 187 are coded as a death and 717 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.
Reports received each year
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
- Gadobutrol side effects
- the label's list beside FAERS reports
- Gadobutrol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other