Gadobutrol: uses, dosing, side effects & brands
Gadobutrol is a gadolinium-based 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
- Gadolinium-Based Contrast Agent
- Available as
- Injectable
- Sold as
- 2 products — Gadavist and Gadobutrol
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How gadobutrol is dosed
From the FDA label for Gadavist (application NDA201277). Other gadobutrol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dose for adults and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous bolus injection. ( 2.1 , 2.2 ) See Full Prescribing Information for administration, imaging, and handling. ( 2.2 , 2.3 ) 2.1 Recommended Dose The recommended dose of GADAVIST for adult and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously. For CMRI, the dose is divided into two separate, equal injections [see Dosage and Administration (2.2) ] . Refer to Table 1 for volumes to be administered for example body weights. Table 1: Volume of GADAVIST for Example Body Weights Body Weight (kg) Volume to be Administered (mL) 2.5 0.25 5 0.5 10 1 15 1.5 20 2 25 2.5 30 3 35 3.5 40 4 45 4.5 50 5 60 6 70 7 80 8 90 9 100 10 110 11 120 12 130 13 140 14 2.2 Administration and Imaging Instructions General GADAVIST is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium-based contrast agents, resulting in a lower volume of administration [see Dosage and Administration (2.1) ]. GADAVIST is for intravenous use only and must not be administered intrathecally [see Warnings and Precautions (5.1) ]. Use aseptic technique when preparing and administering GADAVIST. Visually inspect GADAVIST for particulate matter and…
Gadobutrol side effects
The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness. ( 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 GADAVIST was evaluated in 7,713 subjects (including 184 pediatric population, ages 0 to 17 years) who received GADAVIST in clinical trials. Approximately 52% of the subjects were male and the racial and ethnic distribution was 62% White, 28% Asian, 5% Hispanic or Latino, 2.5% Black or African American, and 2.5% other ethnic groups. The average age was 56 years (range from 1 week to 93 years). Table 2 lists adverse reactions that occurred in ≥ 0.1% subjects who received GADAVIST. Table 2: Adverse Reactions…
Who shouldn’t take gadobutrol
GADAVIST is contraindicated in patients with history of severe hypersensitivity reactions to GADAVIST [see Warnings and Precautions (5.3) ] . History of severe hypersensitivity reaction to GADAVIST ( 4 )
Every gadobutrol 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 gadobutrol keeps
The date on a sealed pack is not the only one: some gadobutrol labels start a second clock once the product is opened or mixed, as short as 24 hours.
Does gadobutrol expire? The in-use limits and storage rules from its labelsGadobutrol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for gadobutrol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadGadobutrol 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. However, because there is no published experience with gadobutrol during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
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 gadobutrol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,146 reports naming gadobutrol, and the FDA flagged 91% 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:
- dyspnoea144 reports
- pruritus136 reports
- nausea130 reports
- urticaria110 reports
- vomiting88 reports
- erythema84 reports
- dizziness83 reports
- hypotension80 reports
Read these as a signal, not a rate. A report does not mean gadobutrol 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 August 25, 2026.
Related calculators
Frequently asked questions
What is gadobutrol?
GADAVIST (gadobutrol) injection is a paramagnetic macrocyclic gadolinium-based contrast agent for intravenous use.
What kind of drug is gadobutrol?
The FDA classifies gadobutrol as a gadolinium-based 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 gadobutrol 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 gadobutrol 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 gadobutrol sold under?
We track 2 gadobutrol-containing products in the U.S.: Gadavist and Gadobutrol. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does gadobutrol come in?
Across the brands we track, gadobutrol 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 gadobutrol?
Yes. Our catalog lists 1 generic gadobutrol product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Gadobutrol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gadobutrol
- MLA
- “Gadobutrol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gadobutrol.
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 gadobutrol on DailyMed (NIH) ↗ — including its boxed warning in full.