ORIGINAL RESEARCH article
Front. Med.
Sec. Dermatology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1559972
This article is part of the Research TopicExploring Innovative Therapies for Rare Inflammatory Skin DiseasesView all 6 articles
Mining and analysis of adverse event signals of Isotretinoin based on the real-world data of FAERS database
Provisionally accepted
- 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
- 2Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
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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.The FAERS database identified 46,526 ISO-related AE reports covering 27 System Organ Classes (SOCs). Of these, 445 AEs showed significant signals across all four algorithms, including 38 previously unlabeled AEs within the top 50 positive Preferred Term (PT) signals. Key IMEs, such as Dandy-Walker syndrome (N=13), childhood depression (N=3), and suicidal ideation (N=2175), were identified, with Gastrointestinal Disorders being the most frequently reported SOC (10,064 reports). AEs occurred most frequently in the early (0-30 days, 23.5%) and mid-treatment phases (91-180 days, 22.7%), with females accounting for 55.9% of the reports.This study identified previously unlabeled AEs and IMEs associated with ISO, including life-threatening events such as Dandy-Walker syndrome, suicidal ideation, and childhood depression, emphasizing the need for updated drug labels and enhanced safety measures. Future research should focus on mechanisms underlying teratogenicity and psychiatric risks to refine ISO's safety profile.
Keywords: Isotretinoin, Pharmacovigilance, FAERS database, adverse events, Signal detection, Pharmacovigilance Methodology, Dandy-Walker Syndrome, Suicidal Ideation
Received: 13 Jan 2025; Accepted: 20 May 2025.
Copyright: © 2025 Yang, Xie, Jia, Cui and Xiao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Zhan-Shuo Xiao, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
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