Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS)
ObjectiveThis study aimed to evaluate the risk of adverse events associated with chloroquine (CQ) and hydroxychloroquine (HCQ) in patients with systemic lupus erythematosus (SLE), using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsDisproportionality a...
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Frontiers Media S.A.
2025-06-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1498814/full |
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| author | Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Si-Qi Zhang Ke-Rui Wang Ke-Rui Wang Shi-Nan Wu Shi-Nan Wu Meng-Yuan Wang Meng-Yuan Wang Cui-Ting Chen Cui-Ting Chen Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong |
| author_facet | Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Si-Qi Zhang Ke-Rui Wang Ke-Rui Wang Shi-Nan Wu Shi-Nan Wu Meng-Yuan Wang Meng-Yuan Wang Cui-Ting Chen Cui-Ting Chen Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong |
| author_sort | Xiang Li |
| collection | DOAJ |
| description | ObjectiveThis study aimed to evaluate the risk of adverse events associated with chloroquine (CQ) and hydroxychloroquine (HCQ) in patients with systemic lupus erythematosus (SLE), using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsDisproportionality analysis was conducted using the Reporting Odds Ratio (ROR) to detect potential safety signals. Sensitivity analyses were performed to validate these signals, and the time to onset for each Preferred Term (PT) was assessed.ResultsBetween 2004 and 2024, a total of 2,575 adverse event reports related to HCQ or CQ use in patients with SLE were identified in the FAERS database, of which 437 involved ocular adverse events. The most frequently reported ocular conditions were cataract, macular degeneration, and glaucoma. Disproportionality analysis demonstrated strong associations between HCQ/CQ use and retinal degeneration (ROR = 28.5, 95%CI: 19.94–40.74), cystoid macular oedema (ROR = 12.46, 95%CI: 8.01–19.37), and optic atrophy (ROR = 6.55, 95%CI: 3.51–12.19). Sensitivity analyses, conducted after excluding SLE cases, indicated that all but one event (vitreous floaters) remained statistically significant, suggesting that these risks are more likely attributable to HCQ/CQ exposure than to the underlying disease. The time-to-onset analysis showed that cataract had the shortest average onset time (125.5 days), whereas retinal degeneration had the longest (937.5 days).ConclusionThe extensive clinical use of HCQ and CQ raises significant concerns regarding their ocular safety profile. This study provides real-world pharmacovigilance evidence supporting a substantial risk of ocular adverse events associated with HCQ/CQ use. Further mechanistic and prospective studies are warranted to elucidate the underlying pathophysiological pathways and to confirm these associations. |
| format | Article |
| id | doaj-art-079b136b63e949919db7a3bf8cb48a62 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-06-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-079b136b63e949919db7a3bf8cb48a622025-08-20T03:28:09ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-06-011610.3389/fphar.2025.14988141498814Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS)Xiang Li0Xiang Li1Xiang Li2Xiang Li3Xiang Li4Xiang Li5Xiang Li6Xiang Li7Si-Qi Zhang8Ke-Rui Wang9Ke-Rui Wang10Shi-Nan Wu11Shi-Nan Wu12Meng-Yuan Wang13Meng-Yuan Wang14Cui-Ting Chen15Cui-Ting Chen16Nuo Dong17Nuo Dong18Nuo Dong19Nuo Dong20Nuo Dong21Nuo Dong22Nuo Dong23Nuo Dong24Xiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Key Laboratory of Ophthalmology, Xiamen, Fujian, ChinaFujian Key Laboratory of Corneal & Ocular Surface Diseases, Xiamen, Fujian, ChinaXiamen Key Laboratory of Corneal & Ocular Surface Diseases, Xiamen, Fujian, ChinaTranslational Medicine Institute of Xiamen Eye Center of Xiamen University, Xiamen, Fujian, ChinaHuaxia Eye Hospital of Quanzhou, Quanzhou, Fujian, ChinaDepartment of Ophthalmology, Affiliated People’s Hospital and Zhenjiang Kangfu Eye Hospital, Zhenjiang College, Zhenjiang, Jiangsu, ChinaDepartment of Oncology, Xiang’an Hospital of Xiamen University, Xiamen, Fujian, ChinaXiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Eye Center and Eye Institute of Xiamen University, School of Medicine, Xiamen, ChinaXiamen Clinical Research Center for Eye Diseases, Xiamen, Fujian, ChinaXiamen Key Laboratory of Ophthalmology, Xiamen, Fujian, ChinaFujian Key Laboratory of Corneal & Ocular Surface Diseases, Xiamen, Fujian, ChinaXiamen Key Laboratory of Corneal & Ocular Surface Diseases, Xiamen, Fujian, ChinaTranslational Medicine Institute of Xiamen Eye Center of Xiamen University, Xiamen, Fujian, ChinaHuaxia Eye Hospital of Quanzhou, Quanzhou, Fujian, ChinaDepartment of Ophthalmology, Affiliated People’s Hospital and Zhenjiang Kangfu Eye Hospital, Zhenjiang College, Zhenjiang, Jiangsu, ChinaObjectiveThis study aimed to evaluate the risk of adverse events associated with chloroquine (CQ) and hydroxychloroquine (HCQ) in patients with systemic lupus erythematosus (SLE), using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsDisproportionality analysis was conducted using the Reporting Odds Ratio (ROR) to detect potential safety signals. Sensitivity analyses were performed to validate these signals, and the time to onset for each Preferred Term (PT) was assessed.ResultsBetween 2004 and 2024, a total of 2,575 adverse event reports related to HCQ or CQ use in patients with SLE were identified in the FAERS database, of which 437 involved ocular adverse events. The most frequently reported ocular conditions were cataract, macular degeneration, and glaucoma. Disproportionality analysis demonstrated strong associations between HCQ/CQ use and retinal degeneration (ROR = 28.5, 95%CI: 19.94–40.74), cystoid macular oedema (ROR = 12.46, 95%CI: 8.01–19.37), and optic atrophy (ROR = 6.55, 95%CI: 3.51–12.19). Sensitivity analyses, conducted after excluding SLE cases, indicated that all but one event (vitreous floaters) remained statistically significant, suggesting that these risks are more likely attributable to HCQ/CQ exposure than to the underlying disease. The time-to-onset analysis showed that cataract had the shortest average onset time (125.5 days), whereas retinal degeneration had the longest (937.5 days).ConclusionThe extensive clinical use of HCQ and CQ raises significant concerns regarding their ocular safety profile. This study provides real-world pharmacovigilance evidence supporting a substantial risk of ocular adverse events associated with HCQ/CQ use. Further mechanistic and prospective studies are warranted to elucidate the underlying pathophysiological pathways and to confirm these associations.https://www.frontiersin.org/articles/10.3389/fphar.2025.1498814/fullcloroquinehydroxychloroquineocular adverse eventsFAERSsystemic lupus erythematosus |
| spellingShingle | Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Xiang Li Si-Qi Zhang Ke-Rui Wang Ke-Rui Wang Shi-Nan Wu Shi-Nan Wu Meng-Yuan Wang Meng-Yuan Wang Cui-Ting Chen Cui-Ting Chen Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Nuo Dong Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) Frontiers in Pharmacology cloroquine hydroxychloroquine ocular adverse events FAERS systemic lupus erythematosus |
| title | Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) |
| title_full | Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) |
| title_fullStr | Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) |
| title_full_unstemmed | Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) |
| title_short | Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS) |
| title_sort | chloroquine and hydroxychloroquine related ocular adverse events in sle treatment a real world disproportionality analysis based on fda adverse event reporting system faers |
| topic | cloroquine hydroxychloroquine ocular adverse events FAERS systemic lupus erythematosus |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1498814/full |
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