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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Cardiovascular and Smooth Muscle Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1517616

Adverse events in different administration routes of amiodarone: a pharmacovigilance study based on the FDA adverse event reporting system

Provisionally accepted
Jingrong Yang Jingrong Yang 1Mengfan You Mengfan You 1Jingxin Wang Jingxin Wang 2*Rongfei Sun Rongfei Sun 3*Lili Han Lili Han 4*Xiaonan Liu Xiaonan Liu 1*Kaibin Niu Kaibin Niu 1*Kaidi Xing Kaidi Xing 1Juanping Sun Juanping Sun 1*Yifei Wang Yifei Wang 5*Wenge Su Wenge Su 5*
  • 1 Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
  • 2 Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
  • 3 Shandong Public Health Clinical Center, Jinan, Shandong Province, China
  • 4 Zhangdian District Traditional Chinese Medicine Hospital, Zibo City, Shandong, China
  • 5 Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China

The final, formatted version of the article will be published soon.

    Background: Arrhythmias are prevalent cardiac disorders with significant impacts on patient quality of life and mortality. Amiodarone, a class III antiarrhythmic agent, is widely used to manage both atrial and ventricular arrhythmias due to its efficacy in prolonging the cardiac action potential and its multiple antiarrhythmic properties. While clinical trials have highlighted the safety and efficacy of amiodarone, there is limited real-world data on adverse events (AEs) associated with different administration routes. This study aims to address this gap by utilizing the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of AEs related to amiodarone administration through disproportionality analysis and stratification methods.Methods:Data from the FAERS database were analyzed using disproportionality analysis , particularly atrial fibrillation (AF) and ventricular arrhythmias (VAs),Despite its clinical benefits, amiodarone is associated with notable adverse drug reactions (ADRs), including extracardiac toxicity and drug-drug interactions, which may vary depending on the route of administration (intravenous or oral).

    Keywords: Amiodarone, Oral, intravenous, fda, adverse events

    Received: 26 Oct 2024; Accepted: 02 Jan 2025.

    Copyright: © 2025 Yang, You, Wang, Sun, Han, Liu, Niu, Xing, Sun, Wang and Su. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Jingxin Wang, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China
    Rongfei Sun, Shandong Public Health Clinical Center, Jinan, Shandong Province, China
    Lili Han, Zhangdian District Traditional Chinese Medicine Hospital, Zibo City, Shandong, China
    Xiaonan Liu, Shandong University of Traditional Chinese Medicine, Jinan, 250355, Shandong Province, China
    Kaibin Niu, Shandong University of Traditional Chinese Medicine, Jinan, 250355, Shandong Province, China
    Juanping Sun, Shandong University of Traditional Chinese Medicine, Jinan, 250355, Shandong Province, China
    Yifei Wang, Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China
    Wenge Su, Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.