Gadoteridol: uses, dosing, side effects & brands
Gadoteridol is a paramagnetic contrast agent sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Paramagnetic Contrast Agent
- Available as
- Injectable
- Sold as
- 2 products — Prohance and Prohance Multipack
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How gadoteridol is dosed
From the FDA label for Prohance (application NDA020131). Other gadoteridol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ( 2.1 ) Follow injection with a saline flush of at least 5 mL normal saline ( 2.1 ) 2.1 Recommended Dose The recommended dose for adult and pediatric patients, including term neonates, is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). Table 1 provides weight-adjusted recommended dose volumes. Table 1: Recommended Volume of ProHance Injection by Body Weight Body Weight (kg) Volume to be Administered (mL) 2.5 0.5 5 1 10 2 20 4 30 6 40 8 50 10 60 12 70 14 80 16 90 18 100 20 110 22 120 24 130 26 140 28 150 30 MRI of the CNS in Adults : A supplementary dose of 0.4 mL/kg (0.2 mmol/kg) may be given up to 30 minutes after the first dose in adult patients with normal renal function suspected of having poorly visualized CNS lesions, in the presence of negative or equivocal scans The safety and efficacy of supplementary dosing have not been established in pediatric patients 2.2 Administration Visually inspect ProHance for particulate matter and discoloration prior to use Do not administer the solution if it is discolored or particulate matter is present Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be…
Gadoteridol side effects
The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic systemic fibrosis [see Boxed Warning and Warnings and Precautions ( 5.2 )] Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, Contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse events described in this section were observed in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to ProHance. Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other. In 5% of the subjects, race was not reported. Average age was 47 years (range from 1 day to 91 years) and the exposure ranged from 0.03 to 0.3 mmol/kg. Overall, approximately 5.8% of subjects reported one or more adverse…
Who shouldn’t take gadoteridol
ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance [see Warnings and Precautions ( 5.3 )]. Allergic or hypersensitivity reactions to ProHance ( 4 )
Every gadoteridol product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
How long gadoteridol keeps
No gadoteridol label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does gadoteridol expire? The in-use limits and storage rules from its labelsGadoteridol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for gadoteridol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAlthough no data exist on the excretion of gadoteridol into milk, only 0.01 to 0.04% of the maternal gadolinium dose is present in breastmilk and there is limited gastrointestinal absorption in the breast-fed infant with other gadolinium contrast agents. Gadoteridol is one of the most stable gadolinium agents, theoretically making it one of the safer drugs to use during breastfeeding. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium.
National Institute of Child Health and Human Development, record revised December 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about gadoteridol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 115 reports naming gadoteridol, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nephrogenic systemic fibrosis25 reports
- anaphylactic reaction13 reports
- muscular weakness13 reports
- rash13 reports
- arthralgia12 reports
- emotional distress12 reports
- pain in extremity12 reports
- skin induration12 reports
Read these as a signal, not a rate. A report does not mean gadoteridol caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is gadoteridol?
ProHance, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, nonpyrogenic injectable solution. Each mL contains 279.3 mg (0.5 mmol/mL) gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection; pH adjusted with hydrochloric acid and/or sodium hydroxide. ProHance contains no antimicrobial preservative.
What kind of drug is gadoteridol?
The FDA classifies gadoteridol as a paramagnetic contrast agent. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take gadoteridol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run gadoteridol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is gadoteridol sold under?
We track 2 gadoteridol-containing products in the U.S.: Prohance and Prohance Multipack. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does gadoteridol come in?
Across the brands we track, gadoteridol is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic gadoteridol?
We do not currently list a generic-labelled gadoteridol product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Gadoteridol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gadoteridol
- MLA
- “Gadoteridol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gadoteridol.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for gadoteridol on DailyMed (NIH) ↗ — including its boxed warning in full.