Clinical features of moderate-to-severe antibiotic allergy in Korea: analysis from the drug allergy safety information sharing system database

Background/Aims: Antibiotics are major causes of drug allergy. Sharing standardized information on culprit agents is essential to prevent recurrent drug allergy. In 2024, the Ministry of Health and Welfare established the Drug Allergy Safety Information Sharing System (DASI), integrated with the Personal Health Record (PHR). We analyzed the epidemiology, culprit antibiotics, clinical manifestations, and diagnostic practices of antibiotic allergy in Korea using DASI data.Methods: We retrospectively reviewed 807 cases of moderate-to-severe antibiotic allergy from eight tertiary hospitals. Clinical features were assessed according to reaction type, severity, MedDRA system organ class, culprit antibiotics, and diagnostic methods.Results: Of 807 cases, the most common manifestations were cutaneous (77.1%), immune (35.2%), and respiratory (23.7%) symptoms. Most cases were caused by β-lactams, particularly second-generation cephalosporins (43.1%). Regarding single agent, cefaclor was the leading culprit (36.7%) and showed significant associations with immediate (odds ratio [OR] 13.88, 95% confidence interval [CI] 7.37–29.75) and severe reactions (OR 3.39, 95% CI 2.52–4.59). Immediate reactions frequently involved multiple organs, while 95.7% of delayed reactions involved the skin. β-lactams were the leading culprits of both immediate and delayed reactions, while sulfamethoxazole/trimethoprim, tetracyclines, and glycopeptides were identified as the major culprits of delayed reactions. Diagnosis relied mainly on clinical assessment (45.4%), while confirmatory drug provocation testing was performed in only 11.8%.Conclusions: Immediate antibiotic allergy in Korea was mainly caused by β-lactams, with cefaclor identified as the leading culprit for severe reactions. Delayed reactions were characterized by a relatively greater contribution of non-β-lactam antibiotics than immediate reactions.