A Comprehensive Study on Adverse Reactions of Benzoyl Peroxide (BPO) in Dermatological Aesthetics Utilizing the FAERS Database.

BACKGROUND

Benzoyl peroxide (BPO) is widely used in dermatological aesthetics for treating acne and other skin conditions. However, its potential adverse reactions remain a concern.

AIMS: This study aimed to investigate the application of BPO in dermatological aesthetics, analyze its associated adverse reactions, and provide insights into patient safety.

METHODS

The study analyzed adverse reaction reports related to BPO in the Food and Drug Administration's Adverse Event Reporting System database from 2004 to 2024. Demographic characteristics, types of adverse reactions, and specific issues related to the novel drug EPSOLAY (5% microencapsulated BPO) were examined.

RESULTS

The findings reveal that BPO users are predominantly female (74.18%), with a significant proportion falling within the 18-44 age group (37.45%). The most common adverse reactions involve skin and subcutaneous tissue disorders (36.34%), including skin swelling, pain, and burning sensations. Reports on EPSOLAY indicate adverse reactions such as erythema, pruritus, and skin exfoliation, but no tumor-related reports have been recorded.

CONCLUSIONS

BPO usage in dermatological aesthetics is associated with various adverse reactions, primarily affecting the skin. The introduction of EPSOLAY has not altered the adverse reaction profile significantly. However, the risk of BPO decomposing into the carcinogen benzene under certain conditions necessitates enhanced patient education, improved production processes, and continuous post-marketing surveillance to ensure drug safety.