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

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Cancer (hematologic malignancies and solid tumors) (n=1778). Intervention: Anthracyclines (aclarubicin, daunorubicin, doxorubicin, epirubicin) vs. Other drugs in the FAERS database. Primary outcome: Disproportionality signals for cardiac adverse events.

Q: What does this research mean for the field?

Individual anthracyclines display distinct real-world cardiotoxicity profiles, with the strongest reporting risk signals observed for acute cardiomyopathy with doxorubicin, heart failure with midrange ejection fraction with epirubicin, left ventricular dysfunction with aclarubicin, and supraventricular arrhythmia with daunorubicin. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Maoxia Fan; Huimin Lu; Jiacheng Zheng; Yawen Wang; Meng Li; Lijing Zhang

doi:10.1155/cdr/8073571

January 1, 2026Cardiovascular TherapeuticsOpen Access

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

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Key result

Anthracyclines show distinct cardiotoxicity profiles, led by doxorubicin for acute cardiomyopathy and epirubicin for HFmrEF.

n=1,778

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Why the study?

Data mining of adverse event signals related to anthracyclines was conducted to explore their potential medication risks, especially cardiotoxicity, to promote rational and safe clinical use.

Does the use of specific anthracyclines (aclarubicin, daunorubicin, doxorubicin, epirubicin) associate with distinct real-world cardiotoxicity profiles in the FAERS database?

Key Points

To identify adverse event signals associated with anthracyclines in the FAERS database, focusing particularly on cardiotoxicity risks to guide clinical safety.
Retrieved adverse event reports from the FAERS database spanning January 1, 2004, to June 30, 2025, for aclarubicin, daunorubicin, doxorubicin, and epirubicin.
Conducted disproportionation analysis using the Bayesian confidence propagation neural network (BCPNN) to detect risk signals across system organ classes.
Extracted 324 adverse event reports for aclarubicin, 298 for daunorubicin, 822 for doxorubicin, and 334 for epirubicin.
Cardiovascular risk signal strengths ranked highest for left ventricular dysfunction with aclarubicin, supraventricular arrhythmia with daunorubicin, acute cardiomyopathy with doxorubicin, and heart failure with midrange ejection fraction with epirubicin.
Cardiac failure accounted for the highest number of cardiac adverse event reports for aclarubicin, doxorubicin, and epirubicin, while tachycardia had the highest reporting count for daunorubicin.

Study Design

Type

Observational (n=1,778)

Structured PICO

Does the use of specific anthracyclines (aclarubicin, daunorubicin, doxorubicin, epirubicin) associate with distinct real-world cardiotoxicity profiles in the FAERS database?

P

Population

1,778 adverse event reports from the FAERS database involving patients treated with anthracyclines to identify signals of cardiotoxicity.

E

Exposure

Anthracyclines (aclarubicin, daunorubicin, doxorubicin, and epirubicin) used commonly to treat hematologic malignancies and solid tumors.

C

Comparator

Other drugs in the FAERS database (used for disproportionation analysis).

O

Outcome

Signals of adverse events related to anthracyclines, focusing on cardiotoxicity, assessed using disproportionation analysis (ROR, PRR, BCPNN, EBGM).safety

This real-world pharmacovigilance study characterizes the distinct cardiotoxicity profiles of different anthracyclines, emphasizing the need for agent-specific and sex-specific cardiovascular monitoring during chemotherapy.

Limitations

Voluntary reporting in FAERS may be affected by various factors, leading to underreporting or overreporting.
Disproportionality analysis provides a statistical assessment of signal strength, not actual clinical risk.
The causal relationship between drugs and adverse events cannot be definitively established due to potential confounding by underlying diseases.
Absence of dose-response analysis prevents assessment of whether signals correlate with cumulative anthracycline exposure.
Lack of adjustment for concomitant cardiotoxic medications and no consideration of time-to-event data.
Inconsistencies in the names of some drugs and adverse events due to multinational reporting
Number of adverse event reports for the year 2025 were incomplete (only captured up to the second quarter)

Implication

May inform agent-specific monitoring; leaves open whether signals guide anthracycline selection in prospective trials.

Abstract

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Discussion

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Cite This Study

Fan et al. (2026) conducted an observational in Cancer (hematologic malignancies and solid tumors) (n=1,778). Anthracyclines (aclarubicin, daunorubicin, doxorubicin, epirubicin) vs. Other drugs in the FAERS database was evaluated on Disproportionality signals for cardiac adverse events. Pharmacovigilance analysis revealed distinct cardiotoxicity profiles, with doxorubicin showing the strongest risk signal for acute cardiomyopathy and epirubicin for heart failure with midrange ejection fraction.

synapsesocial.com/papers/6ad0fce415427f6a840403a2 https://doi.org/10.1155/cdr/8073571

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

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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