{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T21:15:47Z","timestamp":1784754947362,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,7,25]],"date-time":"2025-07-25T00:00:00Z","timestamp":1753401600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Ritlecitinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe alopecia areata in adults and adolescents 12\u2009years and older, which has become a promising treatment. Given their widespread clinical use, a comprehensive real\u2010world study of their adverse events (AEs) is warranted. This study aims to offer insights into the characteristics of ritlecitinib's association with AEs. Disproportionality metrics, including the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean, were employed in our study. AE signals are determined by using these algorithms. The database for analysis, sourced from the FDA Adverse Event Reporting System (FAERS), covers the period from the first quarter of 2023 to the fourth quarter of 2024. A total of 12\u2009390 AEs were identified, with 18 positive signal PTs in our study. The common AEs comprised headache (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200939, ROR 3.22), blood creatine phosphokinase increased (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200924, ROR 57.42), urticaria (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200921, ROR 6.02), acne (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200915, ROR 13.13), infection (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200913, ROR 3.51), drug hypersensitivity (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200913, ROR 3.49), among other AEs. Notably, five new and unexpected significant AEs that were off\u2010label were also found, including diabetes mellitus, hair color changes, thyroid disorder, blood cholesterol abnormality, and increased lipids. Our study could provide a comprehensive safety overview of ritlecitinib during patient treatment and guide its clinical practice.\n                  <\/jats:p>","DOI":"10.1111\/1346-8138.17886","type":"journal-article","created":{"date-parts":[[2025,7,26]],"date-time":"2025-07-26T06:34:51Z","timestamp":1753511691000},"page":"1561-1569","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety Assessment of Ritlecitinib Based on the\n                    <scp>FDA<\/scp>\n                    Adverse Event Reporting System (\n                    <scp>FAERS<\/scp>\n                    ) Database: A Real\u2010World Pharmacovigilance Study"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-8548-0555","authenticated-orcid":false,"given":"Yaping","family":"Huang","sequence":"first","affiliation":[{"name":"Department of Pharmacy Shengli Clinical Medical College of Fujian Medical University, 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