Systematic analysis of adverse reaction signals induced by leflunomide, upadacitinib, and baricitinib in the treatment of rheumatoid arthritis: a FAERS database analysis - Scorecard - 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 Scorecard: Comprehensive Evaluation of Adverse Event Reports Linked to Leflunomide, Upadacitinib, and Baricitinib in Rheumatoid Arthritis Management: Insights from the FAERS Database

At a Glance

CategoryDetail
ConditionRheumatoid Arthritis
Key MechanismsLeflunomide inhibits dihydroorotate dehydrogenase; Upadacitinib and Baricitinib are JAK inhibitors targeting inflammatory pathways.
Target PopulationPatients with Rheumatoid Arthritis
Care SettingPharmacovigilance and postmarketing safety evaluation

Key Highlights

  • 10,445 ADE reports for Leflunomide, 27,433 for Upadacitinib, and 2,638 for Baricitinib.
  • Baricitinib-related ADEs included infections and blood disorders.
  • Leflunomide-related ADEs involved hepatic disorders.
  • Upadacitinib-related ADEs included surgical and medical procedures.
  • Temporal trends in ADE reports varied by drug.

Guideline-Based Recommendations

Diagnosis

  • Monitor for adverse drug events in patients receiving Leflunomide, Upadacitinib, and Baricitinib.

Management

  • Consider alternative therapies based on individual patient response and ADE profiles.

Monitoring & Follow-up

  • Implement enhanced pharmacovigilance frameworks for early identification of adverse drug reactions.

Risks

  • Assess risks of hepatotoxicity, opportunistic infections, and hematological abnormalities.

Patient & Prescribing Data

Patients with Rheumatoid Arthritis requiring DMARD therapy.

Differentiated safety profiles necessitate careful patient selection and monitoring.

Clinical Best Practices

  • Utilize FAERS data for informed clinical decision-making regarding RA therapies.
  • Conduct sex-based analysis of adverse events for tailored patient management.
  • Encourage reporting of adverse events to enhance drug safety monitoring.

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