Antimalarial drugs have been prescribed for years to treat several connective-tissue diseases.1 Epidemiological studies now suggest they may play a role in preventing severe complications in systemic lupus erythematosus (SLE).2 Antimalarial drugs are also used off-label for other systemic autoimmune conditions, including sarcoidosis and Sjögren's syndrome. Indeed, antimalarial drugs are inexpensive and have a good safety profile,3 especially hydroxychloroquine,1 and when systematic monitoring of ophthalmological side-effects is initiated.4 However, some cases of audiovestibular toxicity have been reported anecdotally.5,–,7 We conducted this study to evaluate audiovestibular side-effects in patients treated with antimalarial drugs.

All spontaneous reports of audiovestibular adverse events attributed to antimalarial drugs in the French Pharmacovigilance Network database, between January 1986 and …