Adverse drug events associated with hydroxychloroquine : A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database
- 1Longyan Traditional Chinese Medicine Hospital of Xiamen University, School of Medicine, Xiamen University, Longyan, Fujian, China
- 2Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
- 3Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
Abstract
Background:: Hydroxychloroquine (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 event (AE) from the The FDA’s Adverse Event Reporting System (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 AEs. AE data from 2004 to 2024 were collected, with AE reports of the primary suspected drugs retrieved from the FAERS database. We filtered and analyzed reports related to HCQ use. Four different methods – reporting odds ratio, proportional reporting ratio, the multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network – 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 AEs 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 1 month of starting HCQ; however, the risk of AEs remained even after 2 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.
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BibTeX
@article{yuan2026adverse,
title = {{Adverse drug events associated with hydroxychloroquine : A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database}},
author = {Shiwei Yuan and Zhen Li and Yongchang Yuan and Weifeng Lin and Yuan Zhang and Yongying Zhong and Jinyu Lin and Dong Chen and Wei Guo and Anning Zhu and Siyu Liu},
journal = {Medicine},
year = {2026},
month = oct,
doi = {10.1097/md.0000000000051285},
url = {https://europepmc.org/article/PMC/PMC13727192},
note = {CC BY},
}
RIS
TY - JOUR
TI - Adverse drug events associated with hydroxychloroquine : A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database
AU - Shiwei Yuan
AU - Zhen Li
AU - Yongchang Yuan
AU - Weifeng Lin
AU - Yuan Zhang
AU - Yongying Zhong
AU - Jinyu Lin
AU - Dong Chen
AU - Wei Guo
AU - Anning Zhu
AU - Siyu Liu
PY - 2026
DA - 2026/10/30
JO - Medicine
DO - 10.1097/md.0000000000051285
UR - https://europepmc.org/article/PMC/PMC13727192
AB - Background:: Hydroxychloroquine (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 event (AE) from the The FDA’s Adverse Event Reporting System (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 AEs. AE data from 2004 to 2024 were collected, with AE reports of the primary suspected drugs retrieved from the FAERS database. We filtered and analyzed reports related to HCQ use. Four different methods – reporting odds ratio, proportional reporting ratio, the multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network – 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 AEs 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 1 month of starting HCQ; however, the risk of AEs remained even after 2 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.
SN - 0304-5412
SN - 1536-5964
SN - 0025-7974
ER -