Drug-induced vitiligo: a real-world pharmacovigilance analysis of the FAERS database
Nonger Shen, Qingxia Fang, Yue Wu,Lan Lan, Fangfang Ma
Abstract
Background
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.
Materials and method
2.1. Data source
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).
Results
3.1. Descriptive analysis
A total of 22,249,476 AE reports were extracted from the FAERS database between Q1 2004 and Q4 2024 (Fig 1). After de-duplication and data cleaning, 1,910 cases were found to be associated with vitiligo. The demographic characteristics of the cases included in this study are presented in Table 1, which shows that males and females constituted 35.9% and 45.9% of the cases, respectively.
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.
Conclusion
This pharmacovigilance analysis identified 46 drugs with positive signals for drug-induced vitiligo, 80.4% of which lacked warnings in their FDA-approved labels. Antineoplastic and immunomodulating agents comprised the majority (63.0%, 29/46) of the implicated drugs, including PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, CDK4/6 inhibitors, BRAF/MEK inhibitors, anti-estrogens, aromatase inhibitors, alkylating agents, interleukin inhibitors, interferons, and other monoclonal antibodies.
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.
