European Radiology

, Volume 7, Supplement 5, pp S243–S245 | Cite as

Worldwide clinical safety assessment of gadoteridol injection: an update

  • V. M. Runge
  • J. R. Parker


Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I–IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies.

Key words: Magnetic resonance (MR) contrast enhancement Gadolinium Contrast media paramagnetic Contrast media complications Safety 

Copyright information

© Springer-Verlag Berlin Heidelberg 1997

Authors and Affiliations

  • V. M. Runge
    • 1
  • J. R. Parker
    • 2
  1. 1.Department of Diagnostic Radiology, University of Kentucky, Lexington, KY 40536, USAUS
  2. 2.Department of Medical and Scientific Affairs, Bracco Diagnostics Inc., P. O. Box 5225, Princeton, NJ 08543, USAUS

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