Adverse effects of isotretinoin: A retrospective review of 1743 patients started on isotretinoin

Australas J Dermatol. 2010 Nov;51(4):248-53. doi: 10.1111/j.1440-0960.2010.00657.x.


Background/objectives: Isotretinoin has revolutionized the management of acne vulgaris. However, concerns continue regarding the adverse effect profile of isotretinoin. This study aims to review the adverse effects experienced by patients started on isotretinoin by a single dermatologist.

Methods: Retrospective chart review of 1743 patients started on isotretinoin for various dermatological conditions over a 6-year period. Details of the dose of isotretinoin used, concomitant medications, adverse effects and outcome were recorded.

Results: One-fifth (18.5%) of patients reported no adverse effects during the study period. Cheilitis was the most commonly reported adverse effect, affecting 78% of users, followed by eczema and tiredness, seen in 12% each. However, these were clearly dose-dependent, as the group treated with doses of isotretinoin under 0.25 mg/kg/day only reported cheilitis in 47%, eczema in 7% and tiredness in 5%, compared with 96%, 16% and 18%, respectively, in those treated with more than 0.75 mg/gm/day. Twenty-four patients (1.4%) stopped isotretinoin because of adverse effects; a further three patients complained of severe adverse effects on at least one occasion, but continued taking the medication. The adverse effect(s) that led to patients stopping isotretinoin were cheilitis (22 patients), mood change (13), tiredness (12), eczema (6) and pregnancy (2). There were no reported instances of suicidal ideation or attempted suicide.

Conclusions: Other than the two oral contraceptive failures, there were no serious adverse events recorded during this review period. Isotretinoin is a very effective medication with a low adverse-effect profile when used at lower doses.

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cheilitis / chemically induced
  • Child
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use
  • Dose-Response Relationship, Drug
  • Eczema / chemically induced
  • Fatigue / chemically induced
  • Female
  • Humans
  • Isotretinoin / administration & dosage
  • Isotretinoin / adverse effects*
  • Isotretinoin / therapeutic use
  • Male
  • Middle Aged
  • Mood Disorders / chemically induced
  • Pregnancy, Unplanned
  • Retrospective Studies
  • Young Adult


  • Dermatologic Agents
  • Isotretinoin