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StudyRetina (Philadelphia, Pa.) · 2026

Post-Marketing Ocular Adverse Events Associated with Tamoxifen and Raloxifene: A Population-Based Pharmacovigilance Study.

Abdelrahman Abu Osba, Farah Saleh, Aaryamaan V Verma … Marko Popovic

OphthalmologyStudy

Raloxifene strongly linked to retinal vein thrombosis in safety reports

Post-Marketing Ocular Adverse Events Associated with Tamoxifen and Raloxifene: A Population-Based Pharmacovigilance Study.

Abdelrahman Abu Osba … Marko Popovic

Retina (Philadelphia, Pa.) · 2026

Purpose

The purpose of this study was to evaluate postmarketing ocular adverse events associated with tamoxifen and raloxifene using a pharmacovigilance database.

Methods

The U.

Results

ROR 340.0

Retinal vein blood clot reports were far more common with raloxifene than other drugs

More results

There were a total of 4,084 reports of adverse events associated with tamoxifen (mean age 56.7 years), including 505 ocular adverse events.

The strongest signals were for corneal graft rejection (reporting odds ratios 118.9), retrobulbar hemorrhage (104.6), ophthalmic vein thrombosis (82.7), retinal deposits (80.7), and macular hole (78.6).

More results

Additional events included maculopathy, retinopathy, and optic neuropathy.

There were 5,600 reports of adverse events associated with raloxifene (mean age 68.6 years), including 437 ocular adverse events.

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Conclusion · 1 of 2

Tamoxifen and raloxifene had unique ocular adverse events profiles. Tamoxifen was primarily linked to retinal, optic nerve, and corneal disorders, whereas raloxifene was strongly associated with retinal vascular and thromboembolic events.

Conclusion · 2 of 2

These findings underscore the importance of clinician awareness and future prospective studies to further elucidate the risks.

Post-Marketing Ocular Adverse Events Associated with Tamoxifen and Raloxifene: A Population-Based Pharmacovigilance Study.

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