Related Experiment Video
Updated: Jul 1, 2025
A Multicenter MRI Protocol for the Evaluation and Quantification of Deep Vein Thrombosis
Published on: June 2, 2015
Clinical Safety of Gadobutrol: Review of Over 25 Years of Use Exceeding 100 Million Administrations
Jan Endrikat1, Matthias Gutberlet, Karl-Titus Hoffmann
1From the Bayer AG, Radiology, Berlin, Germany (J.E., L.S., C.H.); Department of Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany (J.E.); Department of Diagnostic and Interventional Radiology, University of Leipzig, Heart Center, Leipzig, Germany (M.G.); Department of Neuroradiology, University of Leipzig, Leipzig, Germany (K.-T.H.); Bayer US LLC, Benefit Risk Management Pharmacovigilance, Whippany, NJ (A.B.); and Department of Radiology and Nuclear Medicine, University Hospital Schleswig Holstein-Campus Luebeck, Luebeck, Germany (J.B.).
Background:
The macrocyclic gadolinium-based contrast agent gadobutrol was introduced to the market in February 1998. Over the last 25 years, gadobutrol has been administered more than 100 million times worldwide providing a wealth of data related to safety.
Objective:
The aim of this study was to perform a thorough review and status update on gadobutrol's safety.
Materials And Methods:
Safety data from the clinical phase II-IV program and postmarketing surveillance were descriptively analyzed from February 1998 until December 31, 2022. Literature on special at-risk populations and specific safety aspects was critically summarized.
Results:
Forty-five clinical phase II-IV studies recruited 7856 patients receiving gadobutrol. Drug-related adverse events (AEs) were reported in 3.4% and serious AEs in <0.1% of patients. Nausea (0.7%) and dysgeusia (0.4%) were the most reported AEs. All other drug-related AEs occurred ≤0.3%. After more than 100 million gadobutrol administrations, overall adverse drug reactions (ADRs) from postmarketing surveillance (including clinical trials) were rare with an overall reporting rate of 0.0356%, hypersensitivity reactions (0.0147%), nausea (0.0032%), vomiting (0.0025%), and dyspnea (0.0010%). All other ADRs were <0.001%. No trend for higher rates of AEs was found in patients with reduced renal or liver function. Seven clinical studies reported safety findings in 7292 children ≤18 years, thereof 112 newborns/toddlers younger than 2 years. Overall, 61 ADRs (0.84%) were reported, including 3 serious ones. Adverse events in patients ≥65 years of age ("elderly") were significantly less frequent than in younger patients. A total of 4 reports diagnostic of or consistent with nephrogenic systemic fibrosis have been received. No causal relationship has been established between clinical signs and symptoms and the presence of small amounts of gadolinium in the body in patients with normal renal function after use of gadobutrol.
Conclusions:
More than 100 million administrations worldwide have shown gadobutrol's well-established benefit-risk profile in any approved indication and populations.
More Related Videos
Related Concept Videos
01:14Imaging Studies I: CT and MRI
Description of the Procedures
Computed Tomography (CT) scan:
Computed Tomography (CT) scans use X-ray technology to generate detailed images of bones, organs, and tissues. During the scan, the patient lies on a moving table...
01:23Lower GI Series: Barium Enema
Procedure Details
The examination begins by inserting a lubricated rectal tube into the patient's rectum to administer a radiopaque barium solution. The barium flow is carefully...
01:30Radiological Investigation I: X-ray and CT
01:25Drug Regulation
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:21Factors Affecting Drug Response: Overview