Mining and analysis of adverse event signals of isotretinoin based on the real-world data of FAERS database.

ABSTRACT:

Objective

Isotretinoin (ISO) is an oral prescription retinoid that is well-known for its effectiveness in treating acne. This study aims to provide valuable insights into the safety of its clinical use by analyzing adverse events (AEs) associated with ISO reported in the FDA Adverse Event Reporting System (FAERS) database.

Methods

FAERS data from Q1 2004 to Q2 2024 were analyzed. Duplicate reports were excluded, and disproportionality analysis using four algorithms (ROR, PRR, BCPNN, EBGM) was performed. AEs were classified using MedDRA terms, with Important Medical Events (IMEs) flagged based on the MedDRA IME list.

Results

The FAERS database identified 46,526 ISO-related AE reports covering 27 System Organ Classes (SOCs). Of these, 445 AEs showed significant signals

SUBMITTER: Yang L 

PROVIDER: S-EPMC12521089 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature