Ocular adverse event profiles associated with endocrine therapies for breast cancer: a global pharmacovigilance study using FAERS and VigiAccess
Abstract
BackgroundOcular adverse events may affect tolerability during long-term endocrine therapy for breast cancer, but comparative real-world evidence remains limited. We characterized ocular adverse-event reporting patterns using the FDA Adverse Event Reporting System (FAERS) and VigiAccess.MethodsFAERS reports from Q1–2004 to Q1–2026 involving seven endocrine therapies were analyzed. Drug-specific signals were assessed using reporting odds ratio (ROR) and information component (IC) within a breast cancer indication-restricted, primary-suspect reference population. Class comparisons used multivariable logistic regression with Benjamini–Hochberg false-discovery-rate correction. Age, ovarian function suppression (OFS), and time to onset (TTO) were evaluated; VigiAccess was descriptive.ResultsAmong 42,851 eligible reports, 2,528 contained ocular adverse events. Tamoxifen showed the broadest signal spectrum, while aromatase inhibitors (AIs) showed ocular-surface and posterior-segment signals. No ocular Preferred Terms met signal criteria for toremifene or elacestrant. FDR-adjusted comparisons showed broader retinal, macular, optic nerve, corneal, and vitreous reporting with selective estrogen receptor modulators (SERMs), particularly versus AIs. Among SERM users, age ≤45 years showed lower reporting odds than age 45–60 years (aOR 0.67, 95% CI 0.46–0.94). Concomitant OFS showed lower reporting odds among AI users (aOR 0.43, 95% CI 0.28–0.63), interpreted as exploratory. Median TTO was 79, 77, and 491 days for AIs, selective estrogen receptor degraders (SERDs), and SERMs.ConclusionsOcular adverse-event reporting differed across endocrine therapies. These findings generate hypotheses for future pharmacoepidemiological, clinical, and mechanistic investigation but should not be interpreted as incidence, causality, or differential clinical risk.
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BibTeX
@article{wang2026ocular,
title = {{Ocular adverse event profiles associated with endocrine therapies for breast cancer: a global pharmacovigilance study using FAERS and VigiAccess}},
author = {Xiaoping Wang and Wenzi Zuo and Chengzhi Zhang and Ben Liu and Bin Zhu},
journal = {Frontiers in Oncology},
year = {2026},
month = nov,
doi = {10.3389/fonc.2026.1970118},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1970118},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Ocular adverse event profiles associated with endocrine therapies for breast cancer: a global pharmacovigilance study using FAERS and VigiAccess
AU - Xiaoping Wang
AU - Wenzi Zuo
AU - Chengzhi Zhang
AU - Ben Liu
AU - Bin Zhu
PY - 2026
DA - 2026/11/02
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1970118
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1970118
AB - BackgroundOcular adverse events may affect tolerability during long-term endocrine therapy for breast cancer, but comparative real-world evidence remains limited. We characterized ocular adverse-event reporting patterns using the FDA Adverse Event Reporting System (FAERS) and VigiAccess.MethodsFAERS reports from Q1–2004 to Q1–2026 involving seven endocrine therapies were analyzed. Drug-specific signals were assessed using reporting odds ratio (ROR) and information component (IC) within a breast cancer indication-restricted, primary-suspect reference population. Class comparisons used multivariable logistic regression with Benjamini–Hochberg false-discovery-rate correction. Age, ovarian function suppression (OFS), and time to onset (TTO) were evaluated; VigiAccess was descriptive.ResultsAmong 42,851 eligible reports, 2,528 contained ocular adverse events. Tamoxifen showed the broadest signal spectrum, while aromatase inhibitors (AIs) showed ocular-surface and posterior-segment signals. No ocular Preferred Terms met signal criteria for toremifene or elacestrant. FDR-adjusted comparisons showed broader retinal, macular, optic nerve, corneal, and vitreous reporting with selective estrogen receptor modulators (SERMs), particularly versus AIs. Among SERM users, age ≤45 years showed lower reporting odds than age 45–60 years (aOR 0.67, 95% CI 0.46–0.94). Concomitant OFS showed lower reporting odds among AI users (aOR 0.43, 95% CI 0.28–0.63), interpreted as exploratory. Median TTO was 79, 77, and 491 days for AIs, selective estrogen receptor degraders (SERDs), and SERMs.ConclusionsOcular adverse-event reporting differed across endocrine therapies. These findings generate hypotheses for future pharmacoepidemiological, clinical, and mechanistic investigation but should not be interpreted as incidence, causality, or differential clinical risk.
SN - 2234-943X
ER -