Ocular adverse effects of systemic treatment with isotretinoin

Arch Dermatol. 2012 Jul;148(7):803-8. doi: 10.1001/archdermatol.2012.352.


Objective: To examine whether isotretinoin therapy could result in deleterious ocular effects, as previously described in case report studies.

Design: Retrospective cohort study.

Setting: The study was conducted using the electronic medical databases of a large health maintenance organization in Israel.

Patients: The study population consisted of 14 682 adolescents and young adults who were new users of isotretinoin for acne and 2 age- and sex-matched comparison groups (isotretinoin-naive patients with acne and acne-free patients).

Main outcome measures: Ocular adverse effects (AEs) or purchases of ophthalmic medications within 1 year after the first dispensed isotretinoin prescription.

Results: In total, 13.8% of the isotretinoin group experienced ocular AEs vs 9.6% of the isotretinoin-naive group and 7.1% of the acne-free group. During a 1-year follow-up period, the isotretinoin group had significantly higher risk for any ocular AEs (hazard ratio, 1.70; P.001) compared with the acne-free group. No such increased risk was observed for the isotretinoin-naive group. The isotretinoin group had higher relative risks for inflammatory and structural AEs.

Conclusion: Isotretinoin use may be associated with short-term ocular events, especially conjunctivitis, underscoring the importance of educating patients and caregivers about these potentially important AEs of the therapy.

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adolescent
  • Case-Control Studies
  • Cohort Studies
  • Conjunctivitis / chemically induced
  • Conjunctivitis / epidemiology
  • Databases, Factual
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use
  • Eye Diseases / chemically induced*
  • Eye Diseases / epidemiology
  • Follow-Up Studies
  • Health Maintenance Organizations
  • Humans
  • Isotretinoin / adverse effects*
  • Isotretinoin / therapeutic use
  • Israel / epidemiology
  • Male
  • Patient Education as Topic / methods
  • Proportional Hazards Models
  • Retrospective Studies
  • Risk
  • Young Adult


  • Dermatologic Agents
  • Isotretinoin