Monitoring adverse drug reactions of isotretinoin: a prospective observational study

Introduction : Acne vulgaris is very common and may have a significant psychosocial effect. Moderate to severe acne is best treated using oral isotretinoin, which has a wide spectrum of adverse drug reactions (ADRs). Aim : To characterize the occurrence, pattern, and severity of isotretinoin-related ADRs in the Iraqi dermatology clinics and clarify clinical and treatment factors linked to its frequency. Patients and methods : This was a prospective observational cohort study carried out at two of the outpatient dermatology clinics in Basra city between January 2024 and December 2025. Patients were recruited consecutively as they were aged 12 years and older and had been taking systemic isotretinoin as the main form of therapy against acne. Results : Out of 420 patients who were screened, 400 patients qualified. The mean age was 21.8 years, and the SD was 4.7 years; 55% of the population was female, and 90% had moderate or severe acne. In general, 360 patients (90%) had at least one ADR, which led to 965 events. The most common were mucocutaneous reactions (88.5% of patients); then there were laboratory abnormalities (22%) and musculoskeletal complaints (around 15%-16%). Biochemical abnormalities were generally mild to moderate, while clinically significant psychiatric events were rare. Moderate/severe ADRs were independently related to female sex, baseline dyslipidemia, and daily dose ≥0.5 mg/kg/day. Conclusion : With the aid of organized monitoring, risk-specific dosing, and strong pregnancy prevention and counseling measures, isotretinoin may be deployed effectively and in a relatively safe way in the Iraqi dermatology clinics.