{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T16:24:38Z","timestamp":1788452678778,"version":"build-2803163510"},"reference-count":27,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T00:00:00Z","timestamp":1751414400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diseases"],"abstract":"<jats:p>Vitiligo, an autoimmune disorder causing depigmented skin patches, includes two types, segmental (SV) and non-segmental (NSV). Previously, NSV was off-label treated using Calcineurine inhibitors (Tacrolimus and Pimecrolimus). In 2022, the FDA approved Ruxolitinib cream, targeting the JAK\/STAT pathway for NSV treatment based on promising results. This research conducts a retrospective descriptive safety assessment of Tacrolimus, Pimecrolimus, and Ruxolitinib safety in vitiligo treatment, utilizing the FDA Adverse Event Reporting System (FAERS) database spanning the period from 2013 to 2023 and including patients aged 2 years and above, encompassing both brand and generic names. A total of 844 adverse event reports involving 388 patients were extracted and categorized into dermatological and systemic groups for analysis. Tacrolimus resulted in 12 hospitalizations, two life-threatening events, and four disabilities. Pimecrolimus exhibited urticaria and pigmentation disorders, with tooth fracture as the primary systemic event. Pericarditis was the predominant systemic side effect of Ruxolitinib, followed by anemia, headache, and urosepsis. Local dermatological side effects reported were generally mild, not warranting treatment cessation. In conclusion, vitiligo significantly impacts patients\u2019 psychological well-being, necessitating continuous post-marketing safety monitoring for topical medications.<\/jats:p>","DOI":"10.3390\/diseases13070208","type":"journal-article","created":{"date-parts":[[2025,7,2]],"date-time":"2025-07-02T06:10:26Z","timestamp":1751436626000},"page":"208","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Descriptive Analysis of Reported Adverse Events Associated with Vitiligo Medications Using FDA Adverse Event Reporting System (FAERS) Databases 2013\u20132023"],"prefix":"10.3390","volume":"13","author":[{"given":"Saleh F.","family":"Alqifari","sequence":"first","affiliation":[{"name":"Faculty of Pharmacy, University of Tabuk, Tabuk 47713, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5460-5174","authenticated-orcid":false,"given":"Musaab Habibulla","family":"Gari","sequence":"additional","affiliation":[{"name":"James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff J.","family":"Guo","sequence":"additional","affiliation":[{"name":"James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH 45267, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoroq","family":"Alamin","sequence":"additional","affiliation":[{"name":"College of Medicine, Sulaiman Alrajhi University, Al Bukairiyah 52726, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8651-8788","authenticated-orcid":false,"given":"Aya K.","family":"Esmail","sequence":"additional","affiliation":[{"name":"College of Medicine, Sulaiman Alrajhi University, Al Bukairiyah 52726, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7979-5036","authenticated-orcid":false,"given":"Abdullah K.","family":"Esmail","sequence":"additional","affiliation":[{"name":"College of Medicine, Sulaiman Alrajhi University, Al Bukairiyah 52726, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heba R.","family":"Hamad","sequence":"additional","affiliation":[{"name":"College of Medicine, Sulaiman Alrajhi University, Al Bukairiyah 52726, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7049-9826","authenticated-orcid":false,"given":"Ahmed","family":"Aljabri","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah 22254, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4638-9990","authenticated-orcid":false,"given":"Amirah M.","family":"Alatawi","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine, Faculty of Medicine, University of Tabuk, Tabuk 47713, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laila A.","family":"Albishi","sequence":"additional","affiliation":[{"name":"Pediatric Department, Faculty of Medicine, University of Tabuk, Tabuk 47713, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed Olaythah","family":"Alraddadi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Faculty of Medicine, University of Tabuk, Tabuk 47713, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helal F.","family":"Hetta","sequence":"additional","affiliation":[{"name":"Division of Microbiology, Immunology and Biotechnology, Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, University of Tabuk, Tabuk 71491, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,2]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1177\/10600280221143748","article-title":"Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo","volume":"57","author":"Hwang","year":"2023","journal-title":"Ann. Pharmacother."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"715","DOI":"10.4103\/0378-6323.102362","article-title":"A descriptive study to characterize segmental vitiligo","volume":"78","author":"Khaitan","year":"2012","journal-title":"Indian J. Dermatol. Venereol. Leprol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1016\/j.det.2016.11.013","article-title":"Genetics of Vitiligo","volume":"35","author":"Spritz","year":"2017","journal-title":"Dermatol. Clin."},{"key":"ref_4","unstructured":"Ahmed jan, N., and Masood, S. (2025). Vitiligo. StatPearls, StatPearls Publishing."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1111\/jocd.15921","article-title":"Efficacy and safety of topical ruxolitinib cream for the treatment of vitiligo: A systematic review and meta-analysis of randomized controlled trials","volume":"23","author":"Ehsan","year":"2024","journal-title":"J. Cosmet. Dermatol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"221","DOI":"10.12998\/wjcc.v3.i3.221","article-title":"Highlights in pathogenesis of vitiligo","volume":"3","author":"Mohammed","year":"2015","journal-title":"World J. Clin. Cases"},{"key":"ref_7","first-page":"e29307","article-title":"Vitiligo: A Narrative Review","volume":"14","author":"Joge","year":"2022","journal-title":"Cureus"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1001\/jamadermatol.2019.0696","article-title":"Treatment Outcomes of Topical Calcineurin Inhibitor Therapy for Patients With Vitiligo: A Systematic Review and Meta-analysis","volume":"155","author":"Lee","year":"2019","journal-title":"JAMA Dermatol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"797","DOI":"10.3892\/etm.2021.10229","article-title":"Updates and new medical treatments for vitiligo (Review)","volume":"22","author":"Wollina","year":"2021","journal-title":"Exp. Ther. Med."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2222","DOI":"10.1111\/jdv.19162","article-title":"Topical ruxolitinib: A new treatment for vitiligo","volume":"37","author":"Tavoletti","year":"2023","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Howell, M.D., Kuo, F.I., and Smith, P.A. (2019). Targeting the Janus Kinase Family in Autoimmune Skin Diseases. Front. Immunol., 10.","DOI":"10.3389\/fimmu.2019.02342"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1038\/clpt.2014.17","article-title":"Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics","volume":"95","author":"Fang","year":"2014","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_13","unstructured":"FDA (2024, January 15). FDA\u2019s Adverse Event Reporting System (FAERS), Available online: https:\/\/www.fda.gov\/drugs\/surveillance\/fdas-adverse-event-reporting-system-faers."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1007\/s11095-020-02921-w","article-title":"Pharmacokinetics and Biodistribution of Tacrolimus after Topical Administration: Implications for Vascularized Composite Allotransplantation","volume":"37","author":"Feturi","year":"2020","journal-title":"Pharm. Res."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1016\/j.jaad.2005.06.013","article-title":"Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: A randomized, investigator-blind comparison","volume":"53","author":"Draelos","year":"2005","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1111\/j.1540-9740.2007.06485.x","article-title":"Tacrolimus in dermatology-pharmacokinetics, mechanism of action, drug interactions, dosages, and side effects: Part I","volume":"7","author":"Sehgal","year":"2008","journal-title":"Skinmed"},{"key":"ref_17","first-page":"739","article-title":"Topical use of pimecrolimus in atopic dermatitis: Update on the safety and efficacy","volume":"7","author":"Werfel","year":"2009","journal-title":"J. Dtsch. Dermatol. Ges."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"703","DOI":"10.1016\/j.transproceed.2004.03.016","article-title":"Hematologic toxicity of immunosuppressive treatment","volume":"36","author":"Danesi","year":"2004","journal-title":"Transplant. Proc."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1093\/ckj\/sfw040","article-title":"Post renal transplant pure red cell aplasia-is tacrolimus a culprit?","volume":"9","author":"Patil","year":"2016","journal-title":"Clin. Kidney J."},{"key":"ref_20","first-page":"A186","article-title":"Impact of different immunosuppressive drugs on QT interval in renal transplant patients","volume":"97","author":"Cosansu","year":"2011","journal-title":"Heart"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1590\/1516-3180.2013.1313472","article-title":"A case of tacrolimus-induced supraventricular arrhythmia after kidney transplantation","volume":"131","author":"Kim","year":"2013","journal-title":"Sao Paulo Med. J."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1016\/j.jaad.2022.09.060","article-title":"Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies","volume":"88","author":"Papp","year":"2023","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1445","DOI":"10.1056\/NEJMoa2118828","article-title":"Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo","volume":"387","author":"Rosmarin","year":"2022","journal-title":"N. Engl. J. Med."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1305","DOI":"10.1016\/j.jaad.2020.02.009","article-title":"Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: Results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study","volume":"82","author":"Kim","year":"2020","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"863","DOI":"10.1016\/j.jaad.2021.04.085","article-title":"Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies","volume":"85","author":"Papp","year":"2021","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1186\/s13045-023-01471-z","article-title":"Ten years of treatment with ruxolitinib for myelofibrosis: A review of safety","volume":"16","author":"Verstovsek","year":"2023","journal-title":"J. Hematol. Oncol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"500","DOI":"10.1016\/j.anai.2022.12.033","article-title":"Safety, pharmacokinetics, and efficacy of ruxolitinib cream in children and adolescents with atopic dermatitis","volume":"130","author":"Leung","year":"2023","journal-title":"Ann. Allergy Asthma Immunol."}],"container-title":["Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2079-9721\/13\/7\/208\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:02:52Z","timestamp":1760032972000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2079-9721\/13\/7\/208"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,2]]},"references-count":27,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["diseases13070208"],"URL":"https:\/\/doi.org\/10.3390\/diseases13070208","relation":{},"ISSN":["2079-9721"],"issn-type":[{"value":"2079-9721","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,2]]}}}