Systematic analysis of adverse reaction signals induced by leflunomide, upadacitinib, and baricitinib in the treatment of rheumatoid arthritis: a FAERS database analysis - Report - MDSpire

Comprehensive Evaluation of Adverse Event Reports Linked to Leflunomide, Upadacitinib, and Baricitinib in Rheumatoid Arthritis Management: Insights from the FAERS Database

  • By

  • Jizheng Dang

  • Li Shu

  • July 21, 2026

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Clinical Report: Adverse Event Reports for Leflunomide, Upadacitinib, Baricitinib

Overview

This study analyzed adverse drug events (ADEs) associated with leflunomide, upadacitinib, and baricitinib in rheumatoid arthritis treatment using the FAERS database. A total of 10,445, 27,433, and 2,638 ADE reports were identified for leflunomide, upadacitinib, and baricitinib, respectively, from January 2004 to December 2024.

Background

Rheumatoid arthritis (RA) is a chronic inflammatory disease that significantly impacts patient quality of life. Leflunomide, upadacitinib, and baricitinib are commonly used treatments.

Data Highlights

DrugADE ReportsPeak Year
Leflunomide10,4452020
Upadacitinib27,4332022
Baricitinib2,6382019

Key Findings

  • Baricitinib-related ADEs included infections and blood disorders.
  • Leflunomide-related ADEs involved hepatic disorders and hereditary diseases.
  • Upadacitinib-related ADEs included surgical and medical procedures.
  • The number of ADE reports for each drug varied significantly over the years.

Clinical Implications

Clinicians should be aware of the specific ADEs associated with leflunomide, upadacitinib, and baricitinib when prescribing these medications. Continuous monitoring of ADEs can inform safer prescribing practices and improve patient outcomes.

Conclusion

This evaluation of ADEs linked to leflunomide, upadacitinib, and baricitinib provides insights for healthcare professionals managing rheumatoid arthritis.

Related Resources & Content

  1. Clinical Rheumatology, 2025 -- Evaluating the Safety Profile of Janus Kinase Inhibitors for Rheumatoid Arthritis: A Disproportionality Study Utilizing the FAERS Database from 2012 to 2022
  2. Drug Safety, 2021 -- Analysis of Thromboembolic Event Reporting Associated with JAK Inhibitors: Insights from the FAERS Database (2010–2019)
  3. Drug Safety, 2020 -- Evaluating the Benefit-Risk Profile of Upadacitinib in Patients with Rheumatoid Arthritis: Insights from a Phase III Study Series
  4. EULAR recommendations, 2025 -- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biologic disease-modifying antirheumatic drugs: 2025 update
  5. Frontiers in Immunology — Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases
  6. FDA Warnings on JAK Inhibitors
  7. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biologic disease-modifying antirheumatic drugs: 2025 update
  8. Risk of Malignancies and Major Adverse Cardiovascular Events Related to JAK Inhibitors in Rheumatoid Arthritis: A Meta-Analysis - PubMed

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