Mining and Analysis of Adverse Event Signals of Isotretinoin Based on the Real-World Data of FAERS Database

This study found that isotretinoin therapy for acne vulgaris typically causes mild mucocutaneous adverse events, which are reversible and vary individually.

Isotretinoin may cause hair loss, especially in women and young adults.

This review highlights that isotretinoin effectively treats acne by addressing its pathogenic mechanisms, although managing its teratogenic risk and side effects through structured monitoring is crucial for safe use.

This review highlights the broad range of adverse effects associated with isotretinoin in acne treatment and examines strategies such as dietary supplementation and adjusted dosing protocols to enhance patient tolerability while maintaining efficacy.

This review synthesizes information on isotretinoin’s systemic toxicity, emphasizing that its adverse effects, including mucocutaneous, hepatic, and musculoskeletal reactions, primarily reflect its pharmacodynamic actions and are generally manageable with individualized dosing and monitoring, though its teratogenicity remains a significant safety concern.