Observational studyInternational ophthalmology2026
Ocular toxicity associated with Ethambutol in the South-East Asia Region.
Observational study in International ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
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Abstract
introductionEthambutol-induced optic neuropathy is a well-documented adverse reaction, the severity of which depends on drug serum concentration in the body. The recent dose-frequency modification for ethambutol from thrice-weekly regimen to daily-dose regimen might have opened doors for increased drug toxicity, resulting in increasing incidence of ocular toxicity. METHODOLOGY: A retrospective, post-market observational study was conducted using data collected from VigiBase® until Jan 2026, using mapped terms under Medical Dictionary for Regulatory Activities (MedDRA).
resultsOf 49,327 ethambutol-suspected adverse event cases reported globally, 4,748 cases were reported under the system organ class (SOC) eye disorders, of which 220 blindness cases were reported globally. Within South-East Asia Region (SEAR), India (n = 820, 79.8%), Thailand (n = 148, 14.4%) and Indonesia (n = 59, 5.7%) reported cases of ethambutol-related eye disorders. Commonly reported preferred terms in SEAR include vision blurred (n = 425, 41.3%), visual impairment (n = 263, 25.6%), optic neuropathy (n = 68, 6.6%), blindness (n = 66, 6.4%) and eye pain (n = 20, 1.9%), with more cases being observed in adults within the age group of 18-64 years. India alone reported 65 cases of blindness followed by Indonesia with 1 case reported.
conclusionThe increased cases of ethambutol-related ocular toxicity specifically blindness warrants periodic monitoring, dose adjustments and exploring newer, safer antibiotics.
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