{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T16:13:18Z","timestamp":1790611998607,"version":"4.1.0"},"reference-count":54,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:00:00Z","timestamp":1757289600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>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).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>A retrospective disproportionality analysis was performed on FAERS reports from the first quarter of 2004 to the fourth quarter of 2024. Disproportionality signals were assessed using the Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The present study identified 1,910 cases of vitiligo, with a median age of 54 years (interquartile range [IQR]: 40.0\u201366.0). The gender distribution among these cases was 45.9% female, 35.9% male, and 18.3% with undetermined gender. The three most frequently reported drugs were nivolumab (152 cases), pembrolizumab (132 cases), and dupilumab (77 cases). Forty-six drugs showed significant positive vitiligo signals. The three strongest signals (based on ROR) were mogamulizumab (ROR 73.93, 95% confidence interval [CI] 39.62\u2013137.94; the lower 95% CI for the information component [IC<jats:sub>025<\/jats:sub>] 2.40), imiquimod (ROR 72.00, 95% CI 43.24\u2013119.89; IC<jats:sub>025<\/jats:sub> 3.00) and chloroquine (ROR 53.33, 95% CI 17.13\u2013166.02; IC<jats:sub>025<\/jats:sub> 0.47). Notably, 80.4% (37\/46) of these drugs lacked vitiligo warnings in their FDA-approved labels.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>This study has uncovered an extensive catalog of drugs with the potential to induce vitiligo. While these findings are based on pharmacovigilance signals and require further validation, patients receiving these medications should be closely monitored for the development of vitiligo.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0332079","type":"journal-article","created":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T17:43:53Z","timestamp":1757353433000},"page":"e0332079","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":8,"title":["Drug-induced vitiligo: a real-world pharmacovigilance analysis of the FAERS database"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-3657-1123","authenticated-orcid":true,"given":"Nonger","family":"Shen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingxia","family":"Fang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yue","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lan","family":"Lan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangfang","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,9,8]]},"reference":[{"issue":"11","key":"pone.0332079.ref001","doi-asserted-by":"crossref","first-page":"2173","DOI":"10.1111\/jdv.19451","article-title":"Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the International Vitiligo Task Force Part 1: towards a new management algorithm","volume":"37","author":"N van Geel","year":"2023","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"17","key":"pone.0332079.ref002","doi-asserted-by":"crossref","first-page":"5225","DOI":"10.3390\/jcm13175225","article-title":"Vitiligo: From Pathogenesis to Treatment","volume":"13","author":"R Speeckaert","year":"2024","journal-title":"J Clin Med"},{"key":"pone.0332079.ref003","doi-asserted-by":"crossref","first-page":"621","DOI":"10.1146\/annurev-immunol-100919-023531","article-title":"Vitiligo: Mechanisms of Pathogenesis and Treatment","volume":"38","author":"ML Frisoli","year":"2020","journal-title":"Annu Rev Immunol"},{"issue":"10","key":"pone.0332079.ref004","doi-asserted-by":"crossref","first-page":"1206","DOI":"10.1111\/j.1365-4632.2011.05377.x","article-title":"A review of the worldwide prevalence of vitiligo in children\/adolescents and adults","volume":"51","author":"C Kr\u00fcger","year":"2012","journal-title":"Int J Dermatol"},{"issue":"1","key":"pone.0332079.ref005","doi-asserted-by":"crossref","first-page":"15011","DOI":"10.1038\/nrdp.2015.11","article-title":"Vitiligo","volume":"1","author":"M Picardo","year":"2015","journal-title":"Nature Reviews Disease Primers"},{"issue":"8","key":"pone.0332079.ref006","doi-asserted-by":"crossref","first-page":"1343","DOI":"10.1111\/jdv.14739","article-title":"The prevalence and odds of depression in patients with vitiligo: a meta-analysis","volume":"32","author":"G Wang","year":"2018","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"pone.0332079.ref007","doi-asserted-by":"crossref","first-page":"6663646","DOI":"10.1155\/2021\/6663646","article-title":"Meta-Analytic Review of High Anxiety Comorbidity among Patients with Vitiligo","volume":"2021","author":"J Liu","year":"2021","journal-title":"Biomed Res Int"},{"key":"pone.0332079.ref008","article-title":"Mental health and psychosocial burden among patients with skin of color living with vitiligo: findings from the global VALIANT study","author":"P Grimes","year":"2025","journal-title":"Dermatology and therapy"},{"issue":"1","key":"pone.0332079.ref009","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1097\/JD9.0000000000000296","article-title":"Cutaneous Adverse Events Under New Clinical Therapies: Drug-Induced Vitiligo-Like Depigmentation","volume":"8","author":"J Ma","year":"2023","journal-title":"International Journal of Dermatology and Venereology"},{"issue":"2","key":"pone.0332079.ref010","doi-asserted-by":"crossref","first-page":"100064","DOI":"10.1016\/j.esmoop.2021.100064","article-title":"Immune checkpoint inhibitor associated vitiligo and its impact on survival in patients with metastatic melanoma: an Italian Melanoma Intergroup study","volume":"6","author":"M Guida","year":"2021","journal-title":"ESMO Open"},{"issue":"8","key":"pone.0332079.ref011","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0255716","article-title":"Prevalence of dermatological toxicities in patients with melanoma undergoing immunotherapy: Systematic review and meta-analysis","volume":"16","author":"NF Mineiro Dos Santos Garrett","year":"2021","journal-title":"PLoS One"},{"issue":"2","key":"pone.0332079.ref012","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1097\/CMR.0000000000000518","article-title":"Cutaneous adverse events of anti-programmed death 1 antibodies combined with anti-cytotoxic T-lymphocyte-associated protein 4 therapy use in patients with metastatic melanoma","volume":"29","author":"SJE Hwang","year":"2019","journal-title":"Melanoma Res"},{"issue":"25","key":"pone.0332079.ref013","doi-asserted-by":"crossref","first-page":"2780","DOI":"10.1200\/JCO.2014.58.3377","article-title":"Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma","volume":"33","author":"RHI Andtbacka","year":"2015","journal-title":"J Clin Oncol"},{"issue":"1","key":"pone.0332079.ref014","doi-asserted-by":"crossref","first-page":"22733","DOI":"10.1038\/s41598-025-06314-0","article-title":"Real world pharmacovigilance study of antineoplastic drug related vitiligo risks","volume":"15","author":"Y Yang","year":"2025","journal-title":"Sci Rep"},{"issue":"6","key":"pone.0332079.ref015","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1111\/1346-8138.17698","article-title":"Vitiligo associated with type 2 immune inhibitors: FAERS analysis and literature review","volume":"52","author":"L Lu","year":"2025","journal-title":"J Dermatol"},{"issue":"6","key":"pone.0332079.ref016","doi-asserted-by":"crossref","first-page":"736","DOI":"10.1111\/fcp.12558","article-title":"Drug-induced vitiligo: a case\/non-case study in Vigibase\u00ae , the WHO pharmacovigilance database","volume":"34","author":"N Anthony","year":"2020","journal-title":"Fundam Clin Pharmacol"},{"issue":"7","key":"pone.0332079.ref017","doi-asserted-by":"crossref","first-page":"796","DOI":"10.7150\/ijms.6048","article-title":"Data mining of the public version of the FDA Adverse Event Reporting System","volume":"10","author":"T Sakaeda","year":"2013","journal-title":"Int J Med Sci"},{"key":"pone.0332079.ref018","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1007\/978-3-319-61845-6_38","article-title":"Post-marketing Drug Safety Evaluation using Data Mining Based on FAERS","volume":"2017","author":"R Duan","year":"2017","journal-title":"Data Min Big Data (2017)"},{"issue":"1","key":"pone.0332079.ref019","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1038\/s41598-024-75421-1","article-title":"Data mining and analysis of adverse events of Vedolizumab based on the FAERS database","volume":"15","author":"Q Xu","year":"2025","journal-title":"Sci Rep"},{"issue":"7","key":"pone.0332079.ref020","doi-asserted-by":"crossref","first-page":"623","DOI":"10.2165\/00002018-200730070-00011","article-title":"Bayesian confidence propagation neural network","volume":"30","author":"A Bate","year":"2007","journal-title":"Drug Saf"},{"issue":"4","key":"pone.0332079.ref021","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1002\/pds.1323","article-title":"Data mining for signals in spontaneous reporting databases: proceed with caution","volume":"16","author":"WP Stephenson","year":"2007","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"1","key":"pone.0332079.ref022","doi-asserted-by":"crossref","DOI":"10.1136\/bmjpo-2022-001839","article-title":"Global clinicoepidemiological pattern of childhood vitiligo: a systematic review and meta-analysis","volume":"7","author":"S Farajzadeh","year":"2023","journal-title":"BMJ Paediatr Open"},{"issue":"5","key":"pone.0332079.ref023","doi-asserted-by":"crossref","first-page":"484","DOI":"10.1093\/ced\/llad028","article-title":"Prevalence and incidence of vitiligo and associated comorbidities: a nationwide population-based study in Korea","volume":"48","author":"H Kang","year":"2023","journal-title":"Clin Exp Dermatol"},{"issue":"9","key":"pone.0332079.ref024","doi-asserted-by":"crossref","first-page":"986","DOI":"10.1001\/jamadermatol.2023.2162","article-title":"Incidence and Prevalence of Diagnosed Vitiligo According to Race and Ethnicity, Age, and Sex in the US","volume":"159","author":"N Mastacouris","year":"2023","journal-title":"JAMA Dermatol"},{"issue":"8","key":"pone.0332079.ref025","first-page":"278","article-title":"Clinical epidemiological profile of vitiligo","volume":"89","author":"S Kiprono","year":"2012","journal-title":"East Afr Med J"},{"issue":"4","key":"pone.0332079.ref026","doi-asserted-by":"crossref","first-page":"2203","DOI":"10.3390\/ijms25042203","article-title":"Clinical and Real-World Effectiveness of Mogamulizumab: A Narrative Review","volume":"25","author":"M Fern\u00e1ndez-Guarino","year":"2024","journal-title":"Int J Mol Sci"},{"issue":"5","key":"pone.0332079.ref027","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.1002\/jvc2.523","article-title":"A case of mogamulizumab\u2010induced vitiligo in a patient with mycosis fungoides","volume":"3","author":"CN Obeng\u2010Nyarko","year":"2024","journal-title":"JEADV Clinical Practice"},{"issue":"2","key":"pone.0332079.ref028","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1684\/ejd.2021.4002","article-title":"Mogamulizumab-induced vitiligo in patients with S\u00e9zary syndrome: three cases","volume":"31","author":"AS Algarni","year":"2021","journal-title":"Eur J Dermatol"},{"issue":"14","key":"pone.0332079.ref029","doi-asserted-by":"crossref","first-page":"4388","DOI":"10.1158\/1078-0432.CCR-18-2575","article-title":"Mogamulizumab Treatment Elicits Autoantibodies Attacking the Skin in Patients with Adult T-Cell Leukemia-Lymphoma","volume":"25","author":"Y Suzuki","year":"2019","journal-title":"Clin Cancer Res"},{"issue":"2","key":"pone.0332079.ref030","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1016\/S0733-8635(02)00094-3","article-title":"Imiquimod","volume":"21","author":"RB Skinner","year":"2003","journal-title":"Dermatologic Clinics"},{"issue":"11","key":"pone.0332079.ref031","doi-asserted-by":"crossref","first-page":"1872","DOI":"10.1111\/j.1524-4725.2012.02512.x","article-title":"Imiquimod-induced depigmentation: report of two cases and review of the literature","volume":"38","author":"CT Burnett","year":"2012","journal-title":"Dermatol Surg"},{"key":"pone.0332079.ref032","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1186\/1471-2334-14-329","article-title":"Induction of vitiligo after imiquimod treatment of condylomata acuminata","volume":"14","author":"W Li","year":"2014","journal-title":"BMC Infect Dis"},{"issue":"4","key":"pone.0332079.ref033","doi-asserted-by":"crossref","first-page":"503","DOI":"10.4103\/0366-6999.199846","article-title":"Vitiligo or Vitiligo-like Hypopigmentation Associated with Imiquimod Treatment of Condyloma Acuminatum: Not a Casual Event","volume":"130","author":"F-Q Long","year":"2017","journal-title":"Chin Med J (Engl)"},{"issue":"1","key":"pone.0332079.ref034","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1002\/iid3.543","article-title":"Imiquimod induced vitiligo-like lesions-A consequence of modified melanocyte function","volume":"10","author":"H Yu","year":"2022","journal-title":"Immun Inflamm Dis"},{"issue":"4","key":"pone.0332079.ref035","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1016\/j.intimp.2012.05.012","article-title":"Targeting Toll-like receptors by chloroquine protects mice from experimental cerebral malaria","volume":"13","author":"X Zhu","year":"2012","journal-title":"Int Immunopharmacol"},{"issue":"6","key":"pone.0332079.ref036","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1067\/mjd.2003.53","article-title":"Chloroquine-induced, vitiligo-like depigmentation","volume":"48","author":"RF Mart\u00edn-Garc\u00eda","year":"2003","journal-title":"J Am Acad Dermatol"},{"issue":"3","key":"pone.0332079.ref037","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1136\/jramc-144-03-11","article-title":"Vitiligo caused by chloroquine phototoxicity","volume":"144","author":"E Selvaag","year":"1998","journal-title":"J R Army Med Corps"},{"issue":"4","key":"pone.0332079.ref038","doi-asserted-by":"crossref","first-page":"956","DOI":"10.1016\/j.jaad.2020.09.054","article-title":"Cutaneous adverse events caused by immune checkpoint inhibitors","volume":"85","author":"HT Quach","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"pone.0332079.ref039","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1016\/j.ejca.2016.02.010","article-title":"Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor","volume":"60","author":"VR Belum","year":"2016","journal-title":"Eur J Cancer"},{"issue":"2","key":"pone.0332079.ref040","doi-asserted-by":"crossref","first-page":"340","DOI":"10.3390\/cancers16020340","article-title":"Incidence of Cutaneous Immune-Related Adverse Events and Outcomes in Immune Checkpoint Inhibitor-Containing Regimens: A Systematic Review and Meta-Analysis","volume":"16","author":"NB Curkovic","year":"2024","journal-title":"Cancers (Basel)"},{"issue":"6","key":"pone.0332079.ref041","doi-asserted-by":"crossref","first-page":"1697","DOI":"10.1007\/s00403-023-02577-7","article-title":"Immune checkpoint inhibitor-induced vitiligo in cancer patients: characterization and management","volume":"315","author":"J Lo","year":"2023","journal-title":"Arch Dermatol Res"},{"issue":"2","key":"pone.0332079.ref042","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1001\/jamadermatol.2024.5136","article-title":"Immune Checkpoint Inhibitor-Induced Vitiligo-Like Depigmentation","volume":"161","author":"M Starace","year":"2025","journal-title":"JAMA Dermatol"},{"key":"pone.0332079.ref043","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1016\/j.jdcr.2023.08.043","article-title":"Guselkumab-induced vitiligo in a patient with psoriatic arthritis","volume":"41","author":"F Martora","year":"2023","journal-title":"JAAD Case Rep"},{"issue":"2","key":"pone.0332079.ref044","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1177\/12034754231157646","article-title":"Novel Interleukin Inhibitors and the Paradoxical Development of Vitiligo: A Systematic Review","volume":"27","author":"KS Raman","year":"2023","journal-title":"J Cutan Med Surg"},{"issue":"1","key":"pone.0332079.ref045","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1111\/jdv.13759","article-title":"New-onset vitiligo and progression of pre-existing vitiligo during treatment with biological agents in chronic inflammatory diseases","volume":"31","author":"L M\u00e9ry-Bossard","year":"2017","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"11","key":"pone.0332079.ref046","doi-asserted-by":"crossref","first-page":"1089","DOI":"10.1007\/s40261-020-00964-w","article-title":"New-Onset Vitiligo During Treatment with Secukinumab: Report of Two Cases and Review of the Literature","volume":"40","author":"LM Nieto-Benito","year":"2020","journal-title":"Clin Drug Investig"},{"key":"pone.0332079.ref047","article-title":"Finasteride","volume-title":"StatPearls","author":"PM Zito","year":"2025"},{"issue":"1","key":"pone.0332079.ref048","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1159\/000455972","article-title":"Post-finasteride adverse effects in male androgenic alopecia: a case report of vitiligo","volume":"30","author":"IG Motofei","year":"2017","journal-title":"Skin pharmacology and physiology"},{"issue":"1","key":"pone.0332079.ref049","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.fertnstert.2019.11.030","article-title":"Post-finasteride syndrome: a surmountable challenge for clinicians","volume":"113","author":"AM Traish","year":"2020","journal-title":"Fertil Steril"},{"issue":"5","key":"pone.0332079.ref050","doi-asserted-by":"crossref","first-page":"382","DOI":"10.56434\/j.arch.esp.urol.20227505.56","article-title":"Post-Finasteride Syndrome. Literature Review","volume":"75","author":"Perez Romero","year":"2022","journal-title":"Archivos espanoles de urologia"},{"issue":"6","key":"pone.0332079.ref051","doi-asserted-by":"crossref","first-page":"1371","DOI":"10.1111\/j.1365-2133.2007.07870.x","article-title":"From the bench to the bedside: proton pump inhibitors can worsen vitiligo","volume":"156","author":"KU Schallreuter","year":"2007","journal-title":"The British journal of dermatology"},{"issue":"1","key":"pone.0332079.ref052","doi-asserted-by":"crossref","first-page":"46","DOI":"10.4103\/0974-2077.79193","article-title":"Proton pump inhibitor induced depigmentation in vitiligo","volume":"4","author":"AP Holla","year":"2011","journal-title":"J Cutan Aesthet Surg"},{"issue":"5","key":"pone.0332079.ref053","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1111\/cod.13919","article-title":"Proton pump inhibitor-induced vitiligo following airborne occupational sensitization","volume":"85","author":"D Kim","year":"2021","journal-title":"Contact Dermatitis"},{"issue":"11","key":"pone.0332079.ref054","doi-asserted-by":"crossref","first-page":"1475","DOI":"10.1111\/jdv.12317","article-title":"Proton pump inhibitors as a possible cause of vitiligo: an in vivo and in vitro study","volume":"28","author":"JM Shin","year":"2014","journal-title":"J Eur Acad Dermatol Venereol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0332079","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T17:44:12Z","timestamp":1757353452000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0332079"}},"subtitle":[],"editor":[{"given":"M Tanveer","family":"Hossain Parash,","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,8]]},"references-count":54,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,8]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0332079","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,8]]}}}