Auditory toxicity of antimalarials in systemic autoimmune diseases: a systematic review and critical appraisal

Antimalarial agents, particularly hydroxychloroquine and chloroquine, are widely used in systemic autoimmune diseases. While ocular toxicity is well established, the extent and clinical relevance of potential auditory toxicity remain unclear. We conducted a systematic review to evaluate the available evidence on auditory adverse effects associated with antimalarial use in systemic autoimmune diseases.

A systematic search was performed in PubMed, Scopus, and the Cochrane Library from inception to January 2025. Observational and interventional studies reporting audiological outcomes in patients exposed to antimalarials were included, excluding malaria-related treatments. Risk of bias was assessed according to study design. Due to substantial clinical and methodological heterogeneity, results were synthesized descriptively without meta-analysis.

Sixteen studies encompassing heterogeneous autoimmune populations and audiological methods were included. The reported prevalence of hearing abnormalities varied widely across studies and diagnostic techniques. Associations with antimalarial exposure, dose, or duration were inconsistent. Some studies described subclinical cochlear or brainstem alterations, while others found no significant differences compared with non-exposed patients.

Available evidence is limited and heterogeneous, precluding causal inferences regarding antimalarial-related auditory toxicity. Increased clinical awareness of auditory symptoms may be reasonable, but standardized monitoring is not supported. Prospective controlled studies with standardized audiological assessments are needed.