Ocular Adverse Events Associated with Docetaxel and Paclitaxel: A Pharmacovigilance Disproportionality Analysis

To examine ocular adverse events associated with docetaxel and paclitaxel using a disproportionality analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS).

FAERS reports from January 2004 to September 2025 listing docetaxel or paclitaxel as the primary suspect drug were analyzed. For 258 ophthalmic MedDRA preferred terms, a signal was required to satisfy both frequentist criteria (reporting odds ratio [ROR], proportional reporting ratio, and chi-square) and the Bayesian information component (IC₀₂₅ >0). Analytic validity was assessed using prespecified positive controls (peripheral sensory neuropathy, neutropenia) and a negative control (road traffic accident). Principal signals were evaluated in sensitivity analyses stratified by sex, age, and reporting period, with findings contextualized by a targeted literature review.

Of 14,104,729 reports, 125,425 (0.9%) involved taxanes. There were 23 signals that satisfied both the frequentist and Bayesian criteria: 19 for docetaxel and 4 for paclitaxel. The highest-magnitude signals for docetaxel involved the eyelid, adnexal, and lacrimal compartments: madarosis (ROR, 722.46), lacrimal structural disorder (ROR, 646.15), and dacryostenosis (ROR, 198.48). Cystoid macular edema (CME) was the strongest paclitaxel signal (ROR, 91.77). Dacryostenosis, increased lacrimation, and CME remained significant across sex, age, and reporting-period strata; madarosis reports were concentrated among females and after 2015.

Taxane chemotherapy generated ocular adverse event signals across multiple ocular compartments, with a broader and higher-magnitude toxicity signal profile for docetaxel than paclitaxel. These findings raise clinical awareness of the breadth of ocular structures potentially affected during taxane therapy, though they require confirmation by studies adjusting for clinical confounders.