Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020.

Background: Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown.

Objectives: This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority.