Objective:

To analyze adverse drug events (ADEs) reported for leflunomide, upadacitinib, and baricitinib in the treatment of rheumatoid arthritis using the FAERS database.

Approach:

• Data Extraction: ADE reports were extracted from the FAERS database from January 2004 to December 2024 and categorized using preferred terms and system organ classes.
• Statistical Analysis: Baseline characteristics of the drugs were analyzed, and temporal trends of ADE reports were plotted using R packages.

Key Findings:

• Total ADE reports: 10,445 for leflunomide, 27,433 for upadacitinib, and 2,638 for baricitinib.
• Baricitinib-related ADEs included infections and infestations and blood and lymphatic system disorders; leflunomide was associated with hepatic disorders and congenital, familial, and hereditary diseases; upadacitinib included surgical and medical procedures.

Interpretation:

Limitations:

• The study is based on reported ADEs, which may not capture all adverse events.
• Data is limited to the FAERS database, which may not represent all patient populations.

Conclusion:

This study identified ADEs in leflunomide, upadacitinib, and baricitinib based on the FAERS database.