Anthracycline Cardiotoxicity: A Real-World Study Based on FDA Adverse Event Reporting System Database

Based on the FDA Adverse Event Reporting System (FAERS) database, data mining of adverse event (AE) signals related to anthracyclines was conducted to explore their potential medication risks, especially cardiotoxicity, in order to promote the rational and safe use of these drugs in clinical practice.

AE data for anthracyclines (represented by aclarubicin, daunorubicin, doxorubicin, and epirubicin) commonly used to treat hematologic malignancies and solid tumors were retrieved from the FAERS database from January 1, 2004, to June 30, 2025. Disproportionation analysis was primarily used to mine signals of AEs related to anthracyclines.

A total of 324 AE reports related to aclarubicin, 298 related to daunorubicin, 822 related to doxorubicin, and 334 related to epirubicin were extracted from the FAERS database. Based on risk signal detection using the Bayesian confidence propagation neural network (BCPNN) for cardiac AEs: For aclarubicin, left ventricular dysfunction exhibited the strongest risk signal among AEs with positive risk signals, whereas cardiac failure had the largest number of reports. For daunorubicin, supraventricular arrhythmia represented the strongest risk signal among AEs with positive risk signals, and tachycardia had the highest reporting count. For doxorubicin, acute cardiomyopathy showed the strongest risk signal among AEs with positive risk signals, whereas cardiac failure possessed the greatest number of reports. For epirubicin, heart failure with midrange ejection fraction yielded the strongest risk signal among AEs with positive risk signals, and cardiac failure had the largest number of reports.

This study provides a more comprehensive insight into the monitoring, supervision, and management of adverse reactions related to anthracyclines. Clinicians should further focus on the impact of various AEs related to anthracyclines and their corresponding signal strengths, especially the cardiotoxicity of anthracyclines, which is of great value for improving the clinical safety of anthracyclines.