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Cho, Moon, Kim, Kang, Lee, Cho, and Kang: Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System



To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.


Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.


A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.


Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.

Figures and Tables

Fig. 1

The number of drug-induced anaphylaxis cases reported annually. ADR, adverse drug reaction.

Table 1

Demographic characteristics of patients with anaphylaxis (n=4,700)


Values are presented as number (%) or mean±standard deviation.

Table 2

Categories of causative agents of drug-induced anaphylaxis (n=6,212)


NSAID, nonsteroidal anti-inflammatory drug.

Table 3

Causal agents of drug-induced anaphylaxis

Table 4

Causative agents of the anaphylaxis-related deaths


NSAID, nonsteroidal anti-inflammatory drug.

Table 5

List of drugs which list anaphylaxis as an adverse drug reaction on FDA drug label but not on domestic drug label


FDA, U.S. Food and Drug Administration.

Table 6

List of drugs which did not list anaphylaxis as an adverse drug reaction on domestic drug label, FDA drug label, and Micromedex


FDA, U.S. Food and Drug Administration; 5-HT4, 5-hydroxytryptamine 4; HMG, 3-hydroxy-methyl glutaryl; CoA, Coenzyme A


This research was supported by a grant from Ministry of Food and Drug Safety to the regional pharmacovigilance center in 2019.


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Hye-Ryun Kang

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