Evaluation of Adverse Reactions of Roxadustat and Daprodustat: A Pharmacovigilance Study.

Purpose

Roxadustat and daprodustat are oral small-molecule drugs widely used in clinical practice for the treatment of renal anemia. This study compared and analyzed the characteristics of adverse events (AEs) related to the 2 drugs after their market release, providing a more comprehensive and accurate basis for clinical judgment when choosing drugs.

Methods

This study used reporting odds ratio (ROR) analysis to assess the safety profiles of 2 drugs recorded in the Japanese Adverse Drug Event Reporting System between 2019 and 2026, and applied χ2 tests to compare the 2 drugs.

Findings

There were 135 AEs possibly related to roxadustat and 108 possibly related to daprodustat. Intergroup comparison revealed that roxadustat was associated with a greater risk of central hypothyroidism (n = 457, ROR = 1504.68), hyperkalemia (n = 113, ROR = 8.09), injury (n = 608, ROR = 4.32), and metabolism and nutrition disorders (n = 309, ROR = 1.35), whereas daprodustat was linked to a higher risk of eye disorders (n = 60, ROR = 1.89), nervous system disorders (n = 294, ROR = 1.53), and tumor progression (n = 188, ROR = 2.24). The analysis of the occurrence time of AEs of the 2 drugs found no significant difference, and the incidence rate of both decreased over time. IMPLICATIONS This study is the first to comprehensively compare roxadustat and daprodustat using a database, revealing significant differences between the 2 drugs across multiple systemic organs. In the clinical selection process, the choice should be made based on the patient's underlying diseases and baseline indicator levels, combined with the AE characteristics of the 2 drugs, to ensure the tolerability and rationality of clinical medication and maximize the benefits for the patients.