The real-world pharmacovigilance study based on the FAERS database analyzed the adverse drug events associated with hydroxychloroquine

Abstract Introduction: HCQ is an antimalarial and immunomodulatory drug widely used to treat autoimmune diseases and other conditions. Despite its significant efficacy, HCQ can cause adverse effects such as gastrointestinal issues, retinal toxicity, and cardiotoxicity. As the application of HCQ in immunotherapy expands, its safety and long-term effects need to be evaluated through big data and clinical observations. In a post-marketing surveillance study conducted from the first quarter of 2004 to the third quarter of 2024, we analyzed HCQ-related adverse events (AEs) from the FAERS database, aiming to provide clinical references for its use. Methods: This retrospective pharmacovigilance study, based on the FAERS database, aimed to explore the association between HCQ and adverse events (AEs). AE data from 2004 to 2024 were collected, with adverse event reports of the primary suspected (PS) drugs retrieved from the FAERS database. We filtered and analyzed reports related to HCQ use. Four different methods—ROR, PRR, MGPS, and BCPNN—were applied to perform disproportionality analysis on the AEs associated with HCQ. Results: The year 2020 had the highest number of AE reports, accounting for 20.44% of the total. In gender-based analysis, women were more likely to report adverse events such as rheumatoid arthritis, disease exacerbation, drug intolerance, nausea, and pain, while men were more prone to report ECG QT prolongation and acute kidney injury. The study highlighted the differences in AE distribution across age groups and genders and pointed out that most AEs occurred within one month of starting HCQ; however, the risk of AEs remained even after two years, emphasizing the importance of long-term monitoring. The findings provided a reference for healthcare professionals and policymakers in developing safer drug usage guidelines. Conclusion: This study emphasizes that HCQ-related adverse reactions are influenced by factors such as gender, age, and underlying diseases, revealing the potential risks associated with the widespread use of HCQ, particularly the risks related to severe adverse reactions. It underscores the importance of continuous drug safety monitoring and suggests the need for individualized risk assessments in clinical settings, especially for patients on long-term use or combination therapies.