Chloroquine has well-documented safety data and adverse effect profiles
Chloroquine possesses well-documented safety data and adverse effect profiles, supported by extensive clinical use and pharmacovigilance studies detailing risks such as ocular and cardiac events.
The retrieved literature extensively documents the safety profile, adverse events, and pharmacovigilance data associated with chloroquine (and its derivative hydroxychloroquine) across multiple clinical contexts like autoimmune and rheumatic diseases. The evidence consistently describes well-characterized risks (e.g., ocular, cardiac, and neuropsychiatric events), directly supporting the claim that its safety data and adverse effect profiles are well-documented.
Al-Hamadani M, Darweesh M, Mohammadi S, Al-Harrasi A. Chloroquine and hydroxychloroquine: Immunomodulatory effects in autoimmune diseases.. 2025. https://doi.org/10.4331/wjbc.v16.i2.107042
Discusses the established clinical applications and long-term side effects of chloroquine and hydroxychloroquine in managing autoimmune diseases.
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Georgios Papazisis, Spyridon Siafis, Dainora Cepaityte, Dimitrios Giannis, Dimitrios Tzachanis, Antoine Egberts. Safety profile of chloroquine and hydroxychloroquine: an analysis of the FDA Adverse Event Reporting System (FAERS) database. 2020. https://doi.org/10.22541/au.158991643.34704253
Analyzes the safety profile and adverse events of chloroquine using real-world FDA pharmacovigilance data.
Li X, Zhang SQ, Wang KR, Wu SN, Wang MY, Chen CT, Dong N. Chloroquine and hydroxychloroquine-related ocular adverse events in SLE treatment: a real-world disproportionality analysis based on FDA adverse event reporting system (FAERS).. 2025. https://doi.org/10.3389/fphar.2025.1498814
Provides real-world evidence from the FAERS database regarding the ocular safety profile and specific risks associated with chloroquine and hydroxychloroquine.
Ates I, Sahin H, Irham LM, Yilmaz S, Suzen S. The Role of Hydroxychloroquine in the Management of Rheumatic Disorders: A Comprehensive Review.. 2025. https://doi.org/10.1111/bcpt.70082
Notes that while widely regarded as safe for rheumatic disorders, chloroquine and hydroxychloroquine have well-documented potential side effects requiring careful evaluation.
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