Long-term tamoxifen citrate use and potential ocular toxicity

Am J Ophthalmol. 1998 Apr;125(4):493-501. doi: 10.1016/s0002-9394(99)80190-1.


Purpose: To estimate the prevalence of abnormalities in visual function and ocular structures associated with the long-term use of tamoxifen citrate.

Methods: A single-masked, cross-sectional study involving multiple community and institutional ophthalmologic departments was conducted with a volunteer sample of 303 women with breast cancer currently taking part in a randomized clinical trial to determine the efficacy of tamoxifen (20 mg/day) in preventing recurrences. Participants included women who had never been on drug (n=85); women who had taken tamoxifen for an average of 4.8 years, then been off the drug for an average of 2.7 years (n=140); and women who had been on tamoxifen continuously for an average of 7.8 years (n=78). Women were evaluated by questionnaire, psychophysical testing, and clinical examination to determine any abnormalities in visual function and the comparative prevalences of corneal, lens, retinal, and optic nerve pathology.

Results: There were no cases of vision-threatening ocular toxicity among the tamoxifen-treated participants. Compared with nontreated participants, the tamoxifen-treated women had no differences in the activities of daily vision, visual acuity measurements, or other tests of visual function except for color screening. Intraretinal crystals (odds ratio [OR]=3.58, P=.178) and posterior subcapsular opacities (OR=4.03, P=.034) were more frequent in the tamoxifen-treated group.

Conclusions: Women should have a thorough baseline ophthalmic evaluation within the first year of initiating tamoxifen therapy and receive appropriate follow-up evaluations.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Breast Neoplasms / prevention & control
  • Cataract / chemically induced
  • Cross-Sectional Studies
  • Eye Diseases / chemically induced*
  • Female
  • Humans
  • Lens, Crystalline / drug effects
  • Longitudinal Studies
  • Middle Aged
  • Neoplasm Recurrence, Local / prevention & control
  • Prevalence
  • Retina / drug effects
  • Retinal Diseases / chemically induced
  • Single-Blind Method
  • Tamoxifen / adverse effects*
  • Tamoxifen / therapeutic use
  • Vision Tests
  • Vision, Ocular / drug effects*


  • Antineoplastic Agents, Hormonal
  • Tamoxifen