• Tsahi T Lerman, Chen Gadot, Noam Greenberg, Boris Kruchin, Ori Rahat, Kirill Buturlin, Aharon Erez, Gustavo Goldenberg, Alon Barsheshet, Gregory Golovchiner, Katia Orvin, Alon Eisen, Amos Levi, Ran Kornowski, Tamar Fishman, Adam Goldman, Lior Seluk, Karen Scandrett, David A Nace, Daniel E Forman, and Boris Fishman.
• The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
• Am. J. Med. 2025 Jan 20.

BackgroundAmiodarone is a widely used antiarrhythmic agent with significant toxicities and drug interactions more likely to affect older adults. Nevertheless, data regarding amiodarone safety in this population are limited.MethodsWe conducted a retrospective analysis of FDA Adverse Event Reporting System (FAERS) data from 2003 to 2024 . Reports with amiodarone as the primary suspect were compared to other antiarrhythmics (sotalol, dronedarone, flecainide, propafenone, dofetilide). Disproportionality analysis assessed reporting odds ratios (RORs) for predefined adverse events in adults (<75 years) and older adults (≥75 years). Interaction analysis evaluated differences between age groups.ResultsAmong 9,196 amiodarone FAERS reports, 4,129 (44.9%) involved older adults. Hyperthyroidism (ROR 39.1, 95% CI [25-61] and ROR of 23.4 [11-49.8]) and hypothyroidism (ROR 36.9 [15.2-89.8] and ROR 24.5 [11.5-52.1]) were substantially over-reported in amiodarone users among both adults and older adults, respectively. Drug-induced liver injury and peripheral neuropathy were also over-reported without a significant age interaction. Interstitial lung disease was reported more frequently in amiodarone users overall, with significantly higher reporting in older adults (ROR 11.4 [6.9-18.6] vs. 4.9 [3.4-7.0], Pinteraction=0.007). Bradycardia was also over-reported in older adults compared to adults (ROR 1.6 [1.3-2] vs. 1.0 [0.8-1.3], Pinteraction=0.003). Torsades de Pointes/QT prolongation were less frequently reported in both age groups.ConclusionsIn this global postmarketing study, interstitial lung disease and bradycardia were more frequently reported in older adults treated with amiodarone. These findings support vigilant monitoring for these adverse events, particularly in older patients.Copyright © 2025. Published by Elsevier Inc.

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