Ocular toxicity in low-dose tamoxifen: a prospective study

Eye (Lond). 1999 Dec:13 ( Pt 6):729-33. doi: 10.1038/eye.1999.217.


Purpose: To look at the incidence, symptomatology, course and reversibility of low-dose tamoxifen ocular toxicity.

Methods: Sixty-five women with breast cancer, on tamoxifen oral therapy (20 mg/day), and a totally normal eye examination, were prospectively followed up. A full ophthalmic evaluation was done every 6 months, for a median of 30 months (range 4-79 months). Any sign of toxicity in the cornea, lens, retina or optic nerve was looked for, whether associated with a change in visual acuity or not.

Results: Ocular toxicity was documented in 8 patients, giving an incidence of 12%. Seven patients had keratopathy in the form of subepithelial deposits, whorls and linear opacities. Three of these patients had a concurrent symptomatic bilateral pigmentary retinopathy that warranted discontinuation of therapy. One patient developed bilateral optic neuritis that left her with optic nerve pallor and a decrease in vision. The patients who had the toxicity had a significantly higher tamoxifen cumulative dose (p = 0.03), and were longer on treatment (p = 0.04), than the non-affected ones. The keratopathy changes were reversible upon discontinuation of the drug.

Conclusion: Prompt reporting of symptoms and yearly ophthalmic examinations are mandatory in patients on tamoxifen to detect toxic effects while these are still reversible.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Antineoplastic Agents, Hormonal / administration & dosage
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Breast Neoplasms / drug therapy
  • Corneal Diseases / chemically induced
  • Drug Administration Schedule
  • Eye Diseases / chemically induced*
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Optic Neuritis / chemically induced
  • Prospective Studies
  • Retinal Diseases / chemically induced
  • Tamoxifen / administration & dosage
  • Tamoxifen / adverse effects*
  • Visual Acuity / drug effects


  • Antineoplastic Agents, Hormonal
  • Tamoxifen