Adverse event of ruxolitinib cream: a real-world analysis based on FDA Adverse Event Reporting System from 2021 to 2024.

Background: Ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, is a widely used treatment for various dermatological diseases. This study employs the FDA Adverse Event Reporting System (FAERS) database to examine adverse events (AEs) associated with ruxolitinib cream.

Methods: This study employed disproportionate analysis methods, including reported odds ratio and proportional reporting ratio, to collate AEs reported from the fourth quarter of 2021 to the first quarter of 2024.

Results: After data processing, 803 reports involving ruxolitinib cream were analyzed. Statistically significant signals were identified for 4 system organ classes (SOCs) and 29 preferred terms (PTs). The most notable signal observed in the SOCs was associated with skin and subcutaneous tissue disorders. For PTs, the AEs observed included clinical symptoms such as pruritus, skin irritation, and burning sensations, as well as signs such as rash, scratching, erythema, and dry skin. Additionally, other observed AEs included diseases such as acne, drug hypersensitivity, and herpes zoster.

Conclusions: This study offers insights into the safety of ruxolitinib cream, improving understanding of its AEs and guiding safer clinical practices. However, the FAERS database lacks data on AE severity and the ability to establish causality, requiring further research to clarify mechanisms behind certain AEs.