Safety of gadoteridol injection: U.S. clinical trial experience.

As part of the clinical evaluation of gadoteridol injection, intravenous doses ranging from 0.05 to 0.3 mmol/kg were administered to 1,709 patients and volunteers. Safety monitoring included pre- and postdose physical examinations, vital signs, and clinical laboratory values. Adverse event recording included occurrence, duration, severity, relationship to injection, and clinical importance. No clinically important changes in physical examination results, electrocardiograms, or vital signs were attributed to gadoteridol injection except for one case of hypotension. Four clinically important changes in laboratory values possibly or definitely related to the contrast agent were noted in two patients (0.1%). Adverse events were recorded in 118 subjects (6.9%), including nausea in 24 subjects (1.4%) and taste perversion in 22 subjects (1.3%). All other adverse events occurred with a frequency of less than 1%. Adverse events related to contrast agent administration occurred in 79 subjects (4.6%). Gadoteridol injection demonstrated excellent clinical safety and patient tolerance at various doses and injection rates.