Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Real-world Adverse Events Associated with Fluconazole and Itraconazole: Analysis of Nationwide Data Using a Spontaneous Reporting System Database

의약품부작용보고시스템 데이터베이스를 이용한 fluconazole 및 itraconazole 관련 이상사례 분석

  • Lee, Yu gyeong (College of Pharmacy and Inje Institute of Pharmaceutical Sciences and Research, Inje University) ;
  • Lee, Jungmin (The Korean Pharmaceutical Association for Patient and Drug Safety Regional Pharmacovigilance Center) ;
  • Chun, Pusoon (College of Pharmacy and Inje Institute of Pharmaceutical Sciences and Research, Inje University)
  • 이유경 (인제대학교 약학대학 인제약학연구소) ;
  • 이정민 (대한약사회 지역의약품안전센터) ;
  • 천부순 (인제대학교 약학대학 인제약학연구소)
  • Received : 2022.09.07
  • Accepted : 2022.09.16
  • Published : 2022.09.30
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Abstract

Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

Keywords

Acknowledgement

We thank the Korean Pharmaceutical Association for Patient and Drug Safety Regional Pharmacovigilance Center for their cooperation in providing access to the KAERS database for this study.

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