ORIGINAL RESEARCH article
Front. Immunol.
Sec. Immunological Memory
Vitiligo secondary to Immunosuppressants: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
Provisionally accepted
- 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
- 2Beijing University of Chinese Medicine, Beijing, China
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Background: Vitiligo is an acquired depigmentation disorder affecting individuals worldwide. The potential link between immunosuppressants and the onset or exacerbation of vitiligo remains a topic of clinical concern. Objective: This study aims to evaluate the association between various immunosuppressants and vitiligo using data from the FDAAdverse Event Reporting System (FAERS). Methods: A retrospective pharmacovigilance analysis was conducted using FAERS data from January 2004 to June 2024. Vitiligo cases were identified through the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analysis was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM) to detect significant drug-event associations. Results: A total of 435 vitiligo-related adverse event (AE) reports were identified. The United States, Canada, France, Germany, and Brazil contributed the most reports. Vitiligo reports were more frequent in female patients, particularly within the 18-65 age group. The primary indications for immunosuppressant use included psoriasis, rheumatoid arthritis, psoriatic arthropathy, Crohn's disease, and ulcerative colitis. Adalimumab (74 cases) and secukinumab (52 cases) accounted for the highest number of reports. Significant signals were detected for alemtuzumab, ixekizumab, ustekinumab, secukinumab, guselkumab, and risankizumab. Conclusion: This study highlights the importance of continuous pharmacovigilance in monitoring potential adverse events associated with immunosuppressants. The observed association between specific immunosuppressants and vitiligo suggests a need for further research to elucidate underlying mechanisms and develop strategies to mitigate these potential AEs.
Keywords: Adverse event, drug-induced vitiligo, FAERS, Pharmacovigilance study, Vitiligo
Received: 17 Sep 2025; Accepted: 09 Feb 2026.
Copyright: © 2026 Jia, Xie, Yang, Cui, Wang 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:
Bingnan Cui
Junhui Wang
Zhan-Shuo Xiao
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