Prescription medicine

Gadoquatrane Brand names: Ambelvist

Gadoquatrane (Ambelvist) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the gadoquatrane FDA label on DailyMed (effective June 12, 2025, Bayer HealthCare Pharmaceuticals Inc.); the NDA 219627 record on Drugs@FDA; every gadoquatrane label on DailyMed.

Highlights of the record

FDA label of June 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

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. AMBELVIST 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 AMBELVIST 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/1.73 m 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. […]

Used for

From the label: indications and usage
AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric patient

Forms and strengths

257.9 mg/ml

Injection.

On the market

Earliest approval on file: June 12, 2026 Ambelvist, Bayer Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
Last listed patent: May 19, 2040 Ambelvist injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is gadoquatrane used for?

From the label: indications and usage
AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)

Source: FDA drug label (Ambelvist), Bayer HealthCare Pharmaceuticals Inc., effective June 12, 2025 (SPL set fac80f5d-8d37-4237-bb52-0faef0dd46aa), via openFDA; the full label on DailyMed

What does the patient leaflet for gadoquatrane 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 AMBELVIST?
GBCAs like AMBELVIST 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 AMBELVIST is safe and effective with intrathecal use. AMBELVIST is not approved for this use. AMBELVIST 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, gadopiclenol, and gadoquatrane. 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 called nephrogenic systemic fibrosis (NSF). Your healthcare provider should screen you to see how well your kidneys are working before you receive AMBELVIST.

Source: FDA drug label (Ambelvist), Bayer HealthCare Pharmaceuticals Inc., effective June 12, 2025 (SPL set fac80f5d-8d37-4237-bb52-0faef0dd46aa), via openFDA; the full label on DailyMed

Is there a generic for gadoquatrane (Ambelvist)?

No generic gadoquatrane is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 6 patents for Ambelvist injection: the compound patent runs to May 30, 2036, and the last listed entry to May 19, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2026 earliest approval on file
2040 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the gadoquatrane label say about other medicines?

The gadoquatrane label names 8 other medicines in its interaction, contraindication or warning sections. 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, gadopiclenol, and gadoquatrane.
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, gadopiclenol, and gadoquatrane.
Gadoterate	warnings and precautions	Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, gadopiclenol, and gadoquatrane.
Gadoteridol	warnings and precautions	Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, gadopiclenol, and gadoquatrane.
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 AMBELVIST administration to Bayer HealthCare (1- 888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Check gadoquatrane against other medicines

Source: FDA drug label (Ambelvist), Bayer HealthCare Pharmaceuticals Inc., effective June 12, 2025 (SPL set fac80f5d-8d37-4237-bb52-0faef0dd46aa), via openFDA; the full label on DailyMed

What next?

Check an interaction: what two or more labels say about each other