Risk and timing of isotretinoin-related laboratory disturbances: a population-based study

Shirin Emtenani, Mariam Abdelghaffar, Ralf J. Ludwig, Enno Schmidt, Khalaf Kridin

Research output: Contribution to journalArticlepeer-review


Introduction: Uncertainty surrounds the optimal routine laboratory monitoring in acne patients treated with isotretinoin. Objective: Our aim was to evaluate the risk of mild and severe laboratory abnormalities in patients with acne starting isotretinoin versus oral antibiotic treatment. Methods: A global population-based retrospective cohort study assigned two groups of patients with acne-prescribed isotretinoin (n = 79,012) and oral antibiotics (n = 79,012). Comprehensive propensity-score matching was conducted. Results: Compared to acne patients treated with oral antibiotics, those under isotretinoin demonstrated an increased risk of grade ≥3 hypertriglyceridemia (hazard ratio [HR], 7.85; 95% confidence interval [CI], 5.58–11.05; P < 0.001) and grade ≥3 elevated aspartate transaminase (AST) levels (HR, 1.45; 95% CI, 1.13–1.85; P = 0.003) within the initial 3 months of treatment. The absolute risk of these abnormalities among isotretinoin initiators was 0.4% and 0.2%, respectively. The risk difference of these findings was clinically marginal: 3 and 1 additional cases per 1,000 patients starting isotretinoin, respectively. There was no significant risk of grade ≥3 impairment in cholesterol, alanine transaminase, gamma-glutamyl transferase, or creatinine levels under isotretinoin. Most laboratory abnormalities were documented 1–3 months after drug initiation in time-stratified analysis. Conclusion: Isotretinoin is associated with a clinically marginal increased risk of severe hypertriglyceridemia and hypertransaminasemia. Routine blood testing should be performed 1–3 months after commencing therapy.

Original languageEnglish
JournalInternational Journal of Dermatology
Early online date3 May 2024
StateE-pub ahead of print - 3 May 2024
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2024 The Authors. International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.


  • acne
  • isotretinoin
  • laboratory abnormalities
  • laboratory disturbances
  • oral antibiotics


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