Drug-induced Vitiligo: A real-world Pharmacovigilance Analysis of the FAERS Database
Nonger Shen, Qingxia Fang, Yue Wu, Lan Lan, Fangfang Ma.
Abstract
In recent years, with the expanding use of novel therapeutics such as immune checkpoint inhibitors and monoclonal antibodies, reports of drug-induced vitiligo have been increasing. This study aimed to identify drugs associated with vitiligo using the FDA Adverse Event Reporting System (FAERS).
Introduction
Vitiligo is an acquired depigmenting disorder characterized by the presence of well-demarcated white patches of varying sizes on the skin [1]. The distribution of these patches may be localized to a specific body area or generalized throughout the body, particularly on exposed areas such as the face, hands, and feet. The etiology of vitiligo has yet to be fully elucidated. However, it is considered a multifactorial disease involving genetic, environmental, and immunological factors.
Materials and Methods:
The FAERS data files, ranging from the first quarter of 2004 to the fourth quarter of 2024, were obtained from the FDA website (https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html). The FAERS structure comprises seven core datasets: demographic/administrative records (DEMO), drug exposure details (DRUG), adverse reaction descriptions coded using MedDRA (REAC), patient outcomes (OUTC), reporting sources (RPSR), therapy duration (THER), and drug indications (INDI).
Discussion
The present study identified and classified the drugs most closely associated with the induction of vitiligo in one of the world’s largest adverse event reporting databases, with data covering the period from January 2004 to December 2024. The analysis demonstrated a fluctuating annual increase in the number of reported cases of drug-induced vitiligo. The top five drugs determined according to the number of case reports in the dataset were nivolumab, pembrolizumab, dupilumab, ipilimumab, and secukinumab, all of which were monoclonal antibody biologic agents. This observation suggests a potential correlation between the increasing number of drug-induced vitiligo cases and the growing clinical application of novel biologic agents and targeted therapies.
Citation: Shen N, Fang Q, Wu Y, Lan L, Ma F (2025) Drug-induced vitiligo: a real-world pharmacovigilance analysis of the FAERS database. PLoS One 20(9): e0332079. https://doi.org/10.1371/journal.pone.0332079
Editor: M Tanveer Hossain Parash,, Universiti Malaysia Sabah, MALAYSIA
Received: June 10, 2025; Accepted: August 26, 2025; Published: September 8, 2025.
Copyright: © 2025 Shen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: The datasets utilized in this study are publicly available from the FAERS database online repository: https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html. This analysis encompassed data from Q1 2004 to Q4 2024.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
