Comparative analysis of adverse events associated with epirubicin and doxorubicin: An observational study based on FDA Adverse Event Reporting System (FAERS) following STROBE guidelines.

Breast cancer has overtaken lung cancer as the leading malignant tumor affecting women in many countries. Chemotherapy is one of the key adjuvant treatments for breast cancer. Epirubicin and Doxorubicin are the cornerstone of chemotherapy regimens used in clinical practice. This research utilized data extracted from the Food and Drug Administration Adverse Event Reporting System covering the period from the first quarter of 2004 to the third quarter of 2024. We confirmed the findings using the Bayesian confidence propagation neural network. From 2004 Q1 to 2024 Q3, Food and Drug Administration Adverse Event Reporting System contained 12,418,989 adverse event reports, with 5732 linked to Epirubicin and 30,613 to Doxorubicin. Febrile neutropenia (Epirubicin: 95% CI lower bound = 10.03, IC-2SD = 3.23; Doxorubicin: 95% CI lower bound = 32.68, IC-2SD = 4.89), cardiotoxicity (Epirubicin: 95% CI lower bound = 22.41, IC-2SD = 3.99; Doxorubicin: 95% CI lower bound = 62.02, IC-2SD = 5.68) exhibited a strong association with both Epirubicin and Doxorubicin. Epirubicin was more prone to the following adverse reactions: granulocyte count decreased (Epirubicin: χ2 = 1092.8, 95% CI lower bound = 34.48, IC-2SD = 3.4). Doxorubicin was more prone to the following adverse reactions: hepatitis b reactivation (Doxorubicin: χ2 = 7899.99, 95% CI lower bound = 39.17, IC-2SD = 4.91). Epirubicin was mainly associated with hematological, cardiac, and hepatobiliary adverse events, while Doxorubicin showed a broader spectrum, including neoplastic disorders and infections. Based on the above differences, the clinical drug selection should be balanced by the patient's hematological status, cardiac function and HBV carrier/infection risk.