{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T00:09:01Z","timestamp":1771546141245,"version":"3.50.1"},"reference-count":42,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Obeticholic acid (OCA) is a farnesoid X nuclear receptor agonist that was approved by the Food and Drug Administration in 2016 for the treatment of primary biliary cholangitis. The aim of this study was to investigate the adverse events (AEs) associated with OCA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We extracted data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from the second quarter of 2016 to the first quarter of 2025. Disproportionality analyses were conducted to assess risk signals of AEs associated with OCA through 4 algorithms, encompassing reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network and empirical Bayesian geometric mean.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 14\u2009859\u2009866 reports from the FAERS database, 6177 reports with OCA as principal suspect AEs were identified. Across 27 organ systems, we identified 187 significant disproportionate preferred terms, which mainly concentrated on gastrointestinal, hepatobiliary, skin and subcutaneous tissue disorders. We also observed unlisted adverse reactions, such as oesophageal varices (ROR 58.39 [95% confidence interval 43.67\u201378.08]) and hepatic fibrosis (ROR 74.95 [95% confidence interval 58.59\u201395.88]). Most AEs occurred within 30\u2009days or after 1\u00a0year of medication, and were more frequent in female patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This real\u2010world study identified OCA\u2010associated AEs, especially some not recorded in the drug insert, and revealed delayed AEs beyond 1\u00a0year. These findings highlight the importance of active monitoring for patient medication safety, and we recommend that the monitoring duration be no less than 1 year.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70186","type":"journal-article","created":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T05:39:30Z","timestamp":1754631570000},"page":"3445-3460","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacovigilance of obeticholic acid: An analysis of the Food and Drug Administration Adverse Event Reporting System database"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-5547-4600","authenticated-orcid":false,"given":"Qining","family":"He","sequence":"first","affiliation":[{"name":"Department of Abdominal Acute Care Surgery General Surgery Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengting","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuchen","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Abdominal Acute Care Surgery General Surgery Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tao","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Abdominal Acute Care Surgery General Surgery Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine  Shanghai 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