J Korean Soc Radiol.  2016 Jul;75(1):41-48. 10.3348/jksr.2016.75.1.41.

Adverse Drug Reactions to CT Contrast Media in South Korea: Incidence and Risk Factors

• Bae K
• Lee SM
• Ha JY
• Jeon KN
• Moon JI
• Choi BH
• Baek HJ
• Cho SB
• Choi DS
• Cho JM
• Na JB

• KMID: 2327366
• DOI: http://doi.org/10.3348/jksr.2016.75.1.41

Abstract

PURPOSE
To evaluate the incidence, severity, and risk factors of adverse drug reactions (ADR) to intravenous administration of nonionic iodinated contrast media in computed tomography (CT), and to determine the recurrence rate after premedication in patients with a previous history of ADR.
MATERIALS AND METHODS
We prospectively recorded all ADR to intravenous CT contrast media in 32313 consecutive outpatients (54572 cases) who underwent contrast enhanced CT examinations. Clinical report forms and electronic medical records were reviewed to search for the incidence of ADR, treatment, and clinical outcome of patients. The risk factors of ADR to CT contrast media (age, sex, history of previous ADR, season) were evaluated using statistical analysis.
RESULTS
Of the 54572 cases, a total of 191 (0.35%) had adverse reactions. Of the 191 cases, 157 (82%) were categorized as mild reactions, 29 (15%) were moderate, and 5 (3%) were severe. A total of 165 (86.4%) cases had acute adverse reactions (which occurred within 1 hour after administration), while 26 (13.6%) had delayed adverse reactions (occurred 1 hour after the administration). The rate of ADR was significantly higher in females [relative risk (RR) = 2.05, 95% confidence interval (CI) 1.53-2.75], patients under the age of 60 years (RR = 1.45, 95% CI 1.07-1.98), patients with a history of previous ADR (RR = 6.51, 95% CI 3.13-13.57), and in the spring season (RR = 1.44, 95% CI 1.07-1.95). The recurrence rate after premedication in patients with previous ADR to CT contrast media was 3.2% (8/247). No deaths occurred that were attributed to the contrast media.
CONCLUSION
The incidence of ADR to nonionic CT contrast media was 0.35%; most of which were mild reactions. Risk factors for ADR included female gender, an age of under 60 years, a history of previous ADR, and spring season.

MeSH Terms

Administration, Intravenous
Contrast Media*
Drug-Related Side Effects and Adverse Reactions*
Electronic Health Records
Female
Humans
Hypersensitivity
Incidence*
Korea*
Outpatients
Premedication
Prospective Studies
Recurrence
Republic of Korea
Risk Factors*
Seasons
Contrast Media

Figure

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  Fig. 1 Comparison of adverse drug reactions to CT contrast media by age. Bars represent mean values and error lines represent standard errors (Appendix 1).

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  Fig. 2 Comparison of adverse drug reactions to CT contrast media by month of the year. Bars represent mean values and error lines represent standard errors (Appendix 2).

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