Taxane-induced macular oedema: disproportionality and timing analyses using FAERS and JADER

Taxanes such as paclitaxel and docetaxel are widely used in malignancies but may cause rare ophthalmic toxicities, including macular oedema. This study clarified occurrence patterns and time to onset by analysing the FDA Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER). In total, 4880 macular oedema cases were reported in FAERS and 523 in JADER; 306 and 97 cases were attributed to paclitaxel, and 54 and 13 to docetaxel, respectively. Disproportionality analysis showed positive reporting signals. Median onset times were 115 d in FAERS and 145 d in JADER for paclitaxel and 104 d in FAERS for docetaxel. Weibull shape parameters indicated a random pattern. Outcomes were mostly favourable for paclitaxel, whereas docetaxel cases showed more non-recovery or sequelae in JADER. Taxane-induced macular oedema is a clinically relevant adverse event requiring continuous ophthalmologic monitoring, and potential regional differences and patient-level risk factors warrant further study.