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Questionnaire survey of acute and delayed adverse reactions to ferumoxides
Tadayoshi Kurata1, Akihiro Tanimoto, Hiroshi Shinmoto
1Department of Diagnostic Radiology, Keio University School of Medicine, Japan.
Purpose:
The purpose of this study was to assess acute and delayed adverse reactions to ferumoxides.
Materials And Methods:
473 consecutive patients who underwent ferumoxides-enhanced MRI were enrolled in this study. Following non-contrast-enhanced MRI, patients were interviewed about their allergic history, and after ferumoxides-enhanced MRI, they were asked to fill out a questionnaire sheet to record any symptoms within one week.
Results:
345 of 473 questionnaires (72.9%) were returned. Fifty-eight of 345 patients (16.8%) showed some adverse reactions considered to be related to ferumoxides: 25 (7.2%) during administration, 25 (7.2%) later on the day of ferumoxides administration, and 17 (4.9%) within one week. Thirty-three patients (9.6%) showed only delayed adverse reactions. Delayed adverse reactions were more frequent in women than in men (p<0.01), and in patients with any allergic history than in those without such history (p<0.05). Acute adverse reactions tended to be more frequent in patients who had some adverse events to any contrast medium than in those with no such history (p=0.069).
Conclusion:
By using the questionnaire, the incidence of adverse reactions to ferumoxides (16.8%) was higher than previously reported from Japanese clinical trials.
Insights
Ferumoxides-enhanced MRI showed a 16.8% incidence of adverse reactions, with delayed reactions more common in women and those with allergies. This finding is higher than previously reported in Japanese trials.
Area of Science:
- Radiology
- Medical Imaging
- Pharmacovigilance
Background:
- Ferumoxides are iron oxide nanoparticles used as contrast agents in MRI.
- Assessing the safety profile of contrast agents is crucial for clinical practice.
Purpose of the Study:
- To evaluate the incidence and characteristics of acute and delayed adverse reactions associated with ferumoxides administration.
- To compare the observed adverse reaction rates with previous clinical trial data.
Main Methods:
- A prospective study involving 473 patients undergoing ferumoxides-enhanced MRI.
- Patient allergic history was recorded pre-scan.
- A questionnaire was used to collect data on adverse reactions within one week post-scan.
Main Results:
- A 72.9% questionnaire return rate was achieved (345/473).
- 16.8% (58/345) of patients reported adverse reactions to ferumoxides.
- Delayed adverse reactions were more prevalent in women and patients with a history of allergies.
Conclusions:
- The incidence of adverse reactions to ferumoxides (16.8%) identified through this questionnaire-based study exceeds rates reported in prior Japanese clinical trials.
- This highlights the importance of post-market surveillance for contrast agent safety.
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