Isotretinoin is one of the most effective drugs to treat patients with severe acne. However, there are some unsolved issues related to its administration. This applies to selection of an adequate dose of the drug, its safety, and stability of disease remission after treatment. The objective of this work was to analyze the literature on the choice of the optimal daily and cumulative dose of isotretinoin, the incidence and causes of relapses of acne after comprehensive treatment, the structure and incidence of the most significant side effects. Material and Methods. We analysed 59 literature sources. The following keywords were used as search criteria: «isotretinoin», «acne», «efficacy», «mechanisms of action», «side effects», «teratogenicity», «depression», «inflammatory intestinal diseases». Conclusion. Isotretinoin have been used for over 30 years, which conclusively proves its high clinical efficacy in treatment of patients with severe acne. However, the data accumulated so far show that some patients have relapses of the disease after the complete course of treatment. Potential complications, some of which appears to be very significant (depression, inflammatory intestinal diseases, etc.) may also significantly limit the use of the drug in clinical practice.