Drug-induced atrial fibrillation: A real-world pharmacovigilance study using the US Food and Drug Administration Adverse Event Reporting System database

Introduction Drug-induced atrial fibrillation is a serious adverse drug reaction (ADR) that occurs during the use of certain medications. The results of ADR signal detection derived from the analysis of a large number of reports, can help understand the safety profile of drugs and optimize clinical practice.Currently, there is a lack of comprehensive quantitative analysis of the major drugs that contribute to atrial fibrillation. Objective To identify the primary drugs associated with atrial fibrillation and provide information for clinical practice. Method We used disproportionality analyses to assess the association between medications and AF adverse events.Data were extracted from the U.S. Food and Drug Administration Adverse Event Reporting System database from January 2004 through December 2024. This study analyzed the distribution of drug types and related drug indications associated with drug-induced AF. Results From the first quarter of 2004 to the fourth quarter of 2024, there were a total of 118,074 adverse reaction reports on AF in the FAERS database. After setting screening criteria, we ultimately screened 80,289 AF-related reports and identified 156 medications associated with pharmacologic AF episodes.A wide range of drugs were reported, with cardiovascular system drugs, antineoplastic drugs and metabolic and endocrine drugs being the most common.Based on the number of reported cases,ibrutinib was the most commonly reported drug followed by rosiglitazone,sacubitril/valsartan,digoxin,dronedarone.Based on the ROR signal intensity,the highest signal intensity was dronedarone followed by eplantersen, propafenone,digoxin,dobutamine. Conclusion Our study provides a real-world overview of drug-induced AF and a list of potential culprit drugs. We examined ADR signals, and the results of ADR signal detection and ADR signal distribution characteristics help to understand the safety profile of a drug and optimize clinical practice.