Gadobutrol
Paramagnetic Contrast Media
Sold as PIXXOSCAN · GADOVIST 1.0
- Drug class
- Paramagnetic Contrast Media
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 13
- FDA reports (12 mo)
- 271
Overview
Gadobutrol is an active pharmaceutical ingredient in the Paramagnetic Contrast Media group (V08CA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 10 | May 29, 2026 |
| US United States | FDA | 1 | July 15, 2025 |
| CA Canada | Health Canada | 2 | May 12, 2026 |
GBUnited Kingdom· MHRA
10 products
Uses
This medicinal product is for diagnostic use only. Gadobutrol is indicated in adults and children of all ages (including term neonates) for: • Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). • Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant.
• Contrast enhancement in magnetic resonance angiography (CE-MRA). Gadobutrol can also be used for MR Imaging of pathologies of the whole body. Gadobutrol facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue.
Gadobutrol should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).
USUnited States· FDA
1 product
Uses
3 ) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). 4 ). 1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) Gadobutrol injection is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
2 MRI of the Breast Gadobutrol injection is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease. 3 Magnetic Resonance Angiography (MRA) Gadobutrol injection is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease.
4 Cardiac MRI Gadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
CACanada· Health Canada
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (2)
Drug interactions
Known interactions involving Gadobutrol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL412030011 · revised September 12, 2025
- [2]FDA DailyMed · 007696d0-4b62-49… · revised July 15, 2025 [PDF]
- [3]Health Canada (DPD) · 02241089 · revised May 12, 2026
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.