Evaluation of clinical adverse effects and laboratory alterations in patients with acne vulgaris treated with oral isotretinoin

BACKGROUND: Oral isotretinoin therapy has completely changed the treatment of acne. The clinical adverse effects of isotretinoin are classified into two groups: mucocutaneous and systemic toxic. Laboratory alterations such as dyslipidemia and increase of hepatic enzymes are reported. OBJECTIVES: To evaluate the tolerability of oral isotretinoin with special attention to lipid metabolism, hepatic function, and clinical adverse reactions. METHODS: 150 patients clinically diagnosed with acne being treated with oral isotretinoin were included in the study. Clinical and laboratory evaluations were conducted before the start of therapy, one month after, and every three months thereafter until the completion of treatment. RESULTS: Of the 150 patients evaluated, 48% were female and 52%, male. They were aged from 15 to 32 years. The most prevalent mucocutaneous adverse reaction associated with isotretinoin therapy was cheilitis, reported by 94% of the patients. Systemic clinical effects were much less common. Cholesterol, triglyceride, and transaminase levels were assessed and significant changes were not observed during treatment. CONCLUSION: Patients showed adverse effects compatible to those described in the literature, which are mostly controlled with symptomatic medication. Isotretinoin is a safe drug and adverse and laboratory effects are well tolerated.