Standardized laboratory monitoring with use of isotretinoin in acne

J Am Acad Dermatol. 2016 Aug;75(2):323-8. doi: 10.1016/j.jaad.2016.03.019. Epub 2016 May 14.


Background: Laboratory monitoring for adverse effects to isotretinoin occurs with variability. Standardization of laboratory monitoring practices represents an opportunity to improve quality of care.

Objective: We sought to develop an evidence-based approach to laboratory monitoring of patients receiving isotretinoin therapy for acne.

Methods: We reviewed laboratory data from 515 patients with acne undergoing 574 courses of isotretinoin from March 2003 to July 2011. Frequency, timing, and severity of abnormalities were determined.

Results: Clinically insignificant leukopenia or thrombocytopenia occurred in 1.4% and 0.9% of patients, respectively. Elevated liver transaminases were detected infrequently and not significantly increased compared with baseline detection rates (1.9% vs 1.6% at baseline). Significant elevations occurred with triglyceride (19.3%) and cholesterol (22.8%) levels. The most severe abnormalities were grade 2 (moderate). Mean duration of treatment before abnormalities were detected was 56.3 days for hypertriglyceridemia, 61.9 days for alanine transaminitis, and 50.1 days for hypercholesterolemia.

Limitations: This was a single-center experience examining variable isotretinoin laboratory monitoring practices.

Conclusions: In healthy patients with normal baseline lipid panel and liver function test results, repeated studies should be performed after 2 months of isotretinoin therapy. If findings are normal, no further testing may be required. Routine complete blood cell count monitoring is not recommended.

Keywords: acne; hypercholesterolemia; hypertriglyceridemia; isotretinoin; laboratory monitoring; leukopenia; thrombocytopenia; transaminitis.

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adolescent
  • Adult
  • Alanine Transaminase / blood
  • Child
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use*
  • Female
  • Humans
  • Hypercholesterolemia / chemically induced
  • Hypertriglyceridemia / chemically induced
  • Isotretinoin / adverse effects*
  • Isotretinoin / therapeutic use*
  • Leukopenia / chemically induced
  • Liver / drug effects
  • Liver / enzymology
  • Liver Function Tests
  • Male
  • Middle Aged
  • Thrombocytopenia / chemically induced
  • Young Adult


  • Dermatologic Agents
  • Alanine Transaminase
  • Isotretinoin