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Molecule

Gadoteridol

Paramagnetic Contrast Agent
Available on requestContrast media and diagnostics
Presentations
10
Brands
1
Manufacturers
1
Available from stock
0

Gadoteridol is a paramagnetic contrast agent indicated for magnetic resonance imaging (MRI) to visualize, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Gadoteridol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Paramagnetic Contrast Agent, Magnetic Resonance Contrast Activity
ATC classification
V08CA04 Gadoteridol · MRI contrast agent, subgroup V08CA
US FDA first approval
16 November 1992
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Identifiers
UNII 0199MV609FRxCUI 25483CAS 120066-54-8DrugBank DB00597Q5516429

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ProHance 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 lesions in the head and neck in adults

Source: US FDA prescribing information

How it works

Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent. In MRI, visualization of normal and pathologic brain tissue depends, in part, on variations in the radiofrequency signal intensity that occur with: 1) differences in proton density, 2) differences of the spin-lattice or longitudinal relaxation times (T1), and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadoteridol decreases T1 relaxation times in the target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.

Source: US FDA prescribing information

Dosing overview

Recommended dose in adult and pediatric patients is 0.2 mL/kg (0.1 mmol/kg) body weight administered as rapid intravenous infusion or bolus. Follow injection with a saline flush of at least 5 mL normal saline

Source: US FDA prescribing information

Contraindications

ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance. Allergic or hypersensitivity reactions to ProHance

Source: US FDA prescribing information

Warnings and precautions

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. ProHance is not approved for intrathecal use. Hypersensitivity: anaphylactic/anaphylactoid reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur. Monitor patients closely for need of emergency cardiorespiratory support. Gadolinium is retained for months or years in brain, bone, and other organs.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic systemic fibrosis Hypersensitivity reactions The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9%

Source: US FDA prescribing information

Storage

Store at 25°C (77° F). Excursions permitted to 15°C to 30°C (59°F to 86°F). DO NOT FREEZE. Should freezing occur in the vial, ProHance should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 60 minutes, ProHance should return to a clear, colorless to slightly yellow solution. Protect from light.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

10 presentations of Gadoteridol, sorted by availability.

MedicineManufacturerRegisterAvailability
Gadoteridol 1396.5 mg/5 mL injectionIntravenousGeneric name—US FDAAvailable on request
Gadoteridol 2793 mg/10 mL injectionIntravenousGeneric name—US FDAAvailable on request
Gadoteridol 4189.5 mg/15 mL injectionIntravenousGeneric name—US FDAAvailable on request
Gadoteridol 5586 mg/20 mL injectionIntravenousGeneric name—US FDAAvailable on request
ProHance 1396.5 mg/5 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request
ProHance 13965 mg/50 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request
ProHance 2793 mg/10 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request
ProHance 27930 mg/100 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request
ProHance 4189.5 mg/15 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request
ProHance 5586 mg/20 mL injectionIntravenousBracco DiagnosticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 November 1992Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Gadoteridol available for export from India?

Yes, on request. MedsAcross lists 10 presentations of Gadoteridol and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Gadoteridol have?

The catalogue lists 1 brand names for Gadoteridol, including ProHance.

Is Gadoteridol approved by the US FDA?

Yes. The US FDA first approved Gadoteridol on 16 November 1992, according to Drugs@FDA.

Does Gadoteridol need cold chain shipping?

No listed presentation of Gadoteridol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Gadoteridol in?

Gadoteridol is classified under ATC code V08CA04 (Gadoteridol).

References

  1. ProHance prescribing information (Bracco Diagnostics). U.S. National Library of Medicine, DailyMed. Retrieved 14 March 2025

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