Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children

Abstract

Background: The safety of gadolinium-based contrast agents is a hot topic in radiology. Purpose: To evaluate the safety profile of gadobutrol during routine use. Material and Methods: Prospective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug reactions (ADR) following gadobutrol administration. Results: A total of 3710 patients were included in the analysis, including 404 children (10.9%). A total of 6026 magnetic resonance imaging examinations of organs/organ systems and 872 magnetic resonance angiography examinations were performed. A total of 22 (0.59%) patients experienced at least one ADR. Nausea and vomiting were the most frequent ADRs, experienced by nine (0.24%) and three (0.08%) patients, respectively. One serious ADR was recorded (anaphylactoid reaction). No deaths were reported. Conclusion: This non-interventional study in 3710 patients confirmed gadobutrol as a safe and reliable contrast agent in adults and children.