{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T01:12:33Z","timestamp":1759799553346,"version":"build-2065373602"},"reference-count":15,"publisher":"Georg Thieme Verlag KG","issue":"08","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Res (Stuttg)"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The aim of this study was to evaluate hepatobiliary disorders adverse events\n                        associated with pembrolizumab by using the Food and Drug Administration\n                        Adverse Event Reporting System (FAERS).<\/jats:p><jats:p>We collected FAERS data from the first quarter of 2009 to the third quarter\n                        of 2024 and used reporting odds ratio (ROR) to detect\n                        pembrolizumab-associated hepatobiliary adverse events (AEs). A signal was\n                        considered significant when the lower limit of the 95% confidence interval\n                        (CI) of the ROR exceeded 1, and\u22655 AEs were reported. Serious and nonserious\n                        cases were compared by statistical analysis, and signals were further\n                        prioritized using a rating scale.<\/jats:p><jats:p>A total of 20,225,379 AEs were reported in the FAERS database, of which\n                        45,774 AEs listed pembrolizumab as the \u2018primary suspected\u2019 drug.\n                        Pembrolizumab treatment was significantly associated with hepatobiliary\n                        disorders. Among these AEs, 101 signals were detected at the preferred term\n                        (PT) levels, and 56 of them were identified as significant signals by using\n                        disproportionality analyses. The median time-to-onset (TTO) was 63 days.\n                        Notably, most hepatobiliary AEs occurred within three months after\n                        pembrolizumab therapy.<\/jats:p><jats:p>Based on pharmacovigilance data from FAERS, different hepatobiliary AEs\n                        should be closely monitored and managed according to the indications for\n                        which pembrolizumab is used.<\/jats:p>","DOI":"10.1055\/a-2662-9565","type":"journal-article","created":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T22:48:59Z","timestamp":1755557339000},"page":"320-325","source":"Crossref","is-referenced-by-count":0,"title":["Pembrolizumab-associated hepatobiliary disorders: a real-world\n                    pharmacovigilance study using the FDA Adverse Events Reporting System\n                    (FAERS)"],"prefix":"10.1055","volume":"75","author":[{"given":"Likun","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ning","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meiyou","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Di","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"JuanLi","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tingting","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingwen","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xijing Hospital, The Fourth Military Medical\n                    University, Xi\u2019an, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2025,8,18]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"582","DOI":"10.1093\/annonc\/mdz011","article-title":"Five-year survival outcomes for patients with advanced melanoma treated with\n                    pembrolizumab in KEYNOTE-001","volume":"30","author":"O Hamid","year":"2019","journal-title":"Ann Oncol"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"908","DOI":"10.1016\/S1470-2045(15)00083-2","article-title":"Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory\n                    melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial","volume":"16","author":"A Ribas","year":"2015","journal-title":"Lancet Oncol"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1093\/annonc\/mdy518","article-title":"Pembrolizumab monotherapy for previously untreated, PD-L1-positive, 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Li","year":"2024","journal-title":"Front Pharmacol"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12041008","article-title":"Public Adverse Event Data Insights into the Safety of Pembrolizumab in Melanoma\n                    Patients","volume":"12","author":"A Schaefer","year":"2020","journal-title":"Cancers (Basel)"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.3390\/ph17101372","article-title":"Pembrolizumab-Associated Cardiotoxicity: A Retrospective Analysis of the FDA\n                    Adverse Events Reporting System","volume":"17","author":"S Milutinovic","year":"2024","journal-title":"Pharmaceuticals (Basel)"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"1222","DOI":"10.1038\/s41598-023-50013-7","article-title":"Assessment of safety profile of secukinumab in realworld scenario using United\n                    States food and drug administration adverse event reporting system database","volume":"14","author":"V Eshwar","year":"2024","journal-title":"Sci Rep"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"19491","DOI":"10.1002\/cam4.6559","article-title":"Analysis on the risk of myasthenia gravis related to immune checkpoint\n                    inhibitors based on the US FDA Adverse Event Reporting System","volume":"12","author":"Q Kong","year":"2023","journal-title":"Cancer Med"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1186\/s40360-024-00821-y","article-title":"A real-world disproportionality analysis of the US Food and Drug Administration\n                    (FDA) adverse event reporting system (FAERS) events for Durvalumab","volume":"25","author":"T Zou","year":"2024","journal-title":"BMC Pharmacol Toxicol"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"500","DOI":"10.1007\/s10637-024-01457-9","article-title":"Post-marketing safety concerns with relugolix: a disproportionality analysis of\n                    the FDA adverse event 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