Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis

While extensive research has been conducted on isotretinoin's systemic side effects, studies focusing on its ocular side effects remain limited and often lack substantial sample sizes. To address this gap, we conducted a comprehensive investigation of isotretinoin-related ocular toxicity using data from the FAERS spanning 2004 to 2024. After excluding duplicate and incomplete records from the FAERS database, we identified 760 eye-related adverse event reports from a total of 45,258 isotretinoin-related entries. We employed the Reporting Odds Ratio (ROR) method to assess the risk of ocular problems. Additionally, we examined the onset timing of eye toxicity. Among the 760 reports analyzed, dry eye emerged as the most frequently reported condition (n = 222), although it did not exhibit the strongest association. The ROR was observed for night blindness (ROR = 35.8, 95% CI = 29.66-43.21), indicating a significant risk. This finding underscores the need to focus on isotretinoin's impact on the retina and fundus, especially since night blindness and vision loss can manifest as early as the first day of treatment. Our study has identified various ocular Preferred Terms (PTs) associated with isotretinoin, highlighting a significant link to retinal effects. Notably, some individuals reported blindness and night blindness following short-term use of isotretinoin. These findings prompt new recommendations for safety monitoring by clinicians. However, additional clinical and fundamental research is essential to substantiate these observations and further elucidate the effects of isotretinoin on ocular health.