Gadoquatrane: uses, dosing, side effects & brands
Gadoquatrane is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Solution
- Sold as
- Ambelvist
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How gadoquatrane is dosed
From the FDA label for Ambelvist (application NDA219627). Other gadoquatrane products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dose for adult and pediatric patients, including term neonates, is 0.01 mmol/kg actual body weight (equivalent to an injection volume of 0.1 mL/kg). ( 2.1 ) Administer the dose by intravenous injection, manually or by compatible power injector, at 1 mL/sec to 4 mL/sec followed by a flush of 0.9% sodium chloride injection; for pediatric patients, adjust the flow rate and flush volume based on age. ( 2.2 ) 2.1 Recommended Dose The recommended dose of AMBELVIST for adult and pediatric patients, including term neonates, is 0.01 mmol/kg actual body weight (equivalent to an injection volume of 0.1 mL/kg) administered intravenously. Clarification on Gadolinium Content Each molecule of gadoquatrane contains four gadolinium (Gd) ions [see Description (11) ] . Therefore, the recommended dose of 0.01 mmol/kg of gadoquatrane (administered as AMBELVIST) delivers 0.04 mmol Gd/kg. 2.2 Administration and Imaging Instructions Administer AMBELVIST as an intravenous injection, manually or by compatible power injector, at a flow rate of approximately 1 mL/second to 4 mL/second, followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. AMBELVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ]. Use aseptic technique when preparing and administering…
Gadoquatrane side effects
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 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 clinical practice. The safety of AMBELVIST was evaluated in four clinical studies in a total of 842 patients who received a single 0.01 mmol/kg dose. This safety population included 697 adult patients from two active comparator, cross-over studies [see Clinical Studies (14.1) ], 52 adult patients from a dose-finding study, and 93 pediatric patients [see Use in Specific Populations (8.4) ] . Adult Patients Among the 749 adult patients (who were exposed to gadoquatrane), the mean age was 56 years (range: 18 years to 89…
Who shouldn’t take gadoquatrane
AMBELVIST is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. History of severe hypersensitivity to AMBELVIST. ( 4 )
Every gadoquatrane product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Ambelvist.
Related calculators
Frequently asked questions
What is gadoquatrane?
AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use.
Can you take gadoquatrane 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 gadoquatrane against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does gadoquatrane come in?
Across the brands we track, gadoquatrane is currently marketed as solution, 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 gadoquatrane?
We do not currently list a generic-labelled gadoquatrane 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). Gadoquatrane: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gadoquatrane
- MLA
- “Gadoquatrane: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gadoquatrane.
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 gadoquatrane on DailyMed (NIH) ↗ — including its boxed warning in full.