Prescription medicine
Gadoteridol Brand names: Prohance
Gadoteridol (Prohance) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the gadoteridol FDA label on DailyMed (effective March 14, 2025, Bracco Diagnostics Inc); the NDA 20131 record on Drugs@FDA; every gadoteridol label on DailyMed.
Highlights of the record
FDA label of March 14, 2025; 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. ProHance 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 ProHance 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 systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR less than 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 (e.g. age greater than 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. […]
Used for
From the label: indications and usageProHance Multipack is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) ProHance
Forms and strengths
- 279.3 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- November 16, 1992 Prohance, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first February 11, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 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
- 1,795 through July 30, 2026
What is gadoteridol used for?
From the label: indications and usageProHance Multipack is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracranial/Extraspinal Tissues ProHance is indicated for MRI in adults to visualize lesions in the head and neck. […]
FDA pharmacologic class: Paramagnetic Contrast Agent.
Source: FDA drug label (ProHance), Bracco Diagnostics Inc, effective March 14, 2025 (SPL set e8b76200-c0aa-491b-aad7-e22d2f68496f), via openFDA; the full label on DailyMed
What does the patient leaflet for gadoteridol 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 PROHANCE?GBCAs like PROHANCE 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 PROHANCE is safe and effective with intrathecal use. PROHANCE is not approved for this use. PROHANCE 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 Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. 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 PROHANCE.
Source: FDA drug label (ProHance), Bracco Diagnostics Inc, effective March 14, 2025 (SPL set e8b76200-c0aa-491b-aad7-e22d2f68496f), via openFDA; the full label on DailyMed
Is there a generic for gadoteridol (Prohance)?
The FDA approved the first generic gadoteridol on February 11, 2025. 1 generic application is approved; 1 of it carries 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 gadoteridol from 1 labeler 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.
- 1992 earliest approval on file
- 2025 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gadoteridol label say about other medicines?
The gadoteridol label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadoteridol. 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, retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadodiamide | warnings and precautions | At equivalent doses, retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadoterate | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoxetate | warnings and precautions | At equivalent doses, retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
Source: FDA drug label (ProHance), Bracco Diagnostics Inc, effective March 14, 2025 (SPL set e8b76200-c0aa-491b-aad7-e22d2f68496f), via openFDA; the full label on DailyMed
What do FAERS reports show for gadoteridol?
The FDA Adverse Event Reporting System holds 1,795 reports that list gadoteridol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 160 are coded as a death and 374 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 paramagnetic contrast agents
- the pharmacologic class, with prices and generics
- Gadoteridol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other