{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T06:04:23Z","timestamp":1780639463097,"version":"3.54.1"},"reference-count":21,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T00:00:00Z","timestamp":1780617600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Elagolix and Myfembree are gonadotropin-releasing hormone (GnRH)-pathway therapies used for endometriosis, but their post-marketing safety reporting patterns remain incompletely characterized. Because spontaneous reporting databases are susceptible to reporting bias and differential market exposure, comparative analyses require cautious interpretation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed quarterly data from the FDA Adverse Event Reporting System (FAERS) from 2015Q3 to 2026Q1. Deduplicated female reports with endometriosis-related indications were identified and classified as elagolix, Myfembree, or other endometriosis-related reports. The primary analysis consisted of drug-specific case-noncase disproportionality analyses for elagolix and Myfembree separately within the female endometriosis reporting background. A direct elagolix-versus-Myfembree head-to-head analysis was performed as a secondary analysis. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and information components (ICs) were calculated at the preferred term (PT) level. Sensitivity analyses included serious-report-only, healthcare-professional-only, physician-only, complete-age, reporter-type-stratified, overlapping-market-period, and bootstrap analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 4,428 deduplicated female endometriosis-related reports were included, comprising 1,744 elagolix reports, 280 Myfembree reports, and 2,404 other endometriosis-related reports. Serious reports accounted for 31.2% of elagolix reports and 26.8% of Myfembree reports. In drug-specific case-noncase analyses, elagolix showed robust disproportionality signals for hot flush, night sweats, and suicidal ideation. Myfembree showed distinct reporting signals for reproductive and bleeding-related PTs, including heavy menstrual bleeding and intermenstrual bleeding. In the secondary head-to-head analysis, selected PTs including hot flush, nausea, headache, depression, arthralgia, and suicidal ideation showed higher reporting signals for elagolix, whereas alopecia showed a lower reporting signal for elagolix. Sensitivity analyses using alternative algorithms, reporter-type restrictions, overlapping-market-period restriction, complete-age restriction, and bootstrap validation generally supported the direction of the main selected reporting patterns, although some estimates were limited by small cell counts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Elagolix and Myfembree showed distinct post-marketing reporting signal profiles among female endometriosis-related FAERS reports. Elagolix was characterized mainly by vasomotor and selected neuropsychiatric reporting signals, whereas Myfembree was characterized mainly by reproductive and bleeding-related reporting signals. These findings represent hypothesis-generating reporting differences rather than clinical incidence rates or causal risk estimates. Further pharmacoepidemiologic studies with denominator data and adjustment for patient-level confounding are needed to clarify comparative safety profiles.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1860816","type":"journal-article","created":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T05:37:32Z","timestamp":1780637852000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative post-marketing reporting signals of elagolix and myfembree in endometriosis: a FAERS pharmacovigilance study"],"prefix":"10.3389","volume":"17","author":[{"given":"MengLong","family":"Bai","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Women and Children\u2019s Hospital, School of Medicine, Xiamen University","place":["Xiamen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiju","family":"Shen","sequence":"additional","affiliation":[{"name":"Charite - Universitatsmedizin Berlin","place":["Berlin, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin-Yuan","family":"Chen","sequence":"additional","affiliation":[{"name":"Central Laboratory, The First Affiliated Hospital, Fujian Medical University","place":["Fuzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,6,5]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1016\/j.xfre.2022.11.010","article-title":"Development of relugolix combination therapy as a medical treatment option for women with uterine fibroids or endometriosis","volume":"4","author":"Arjona Ferreira","year":"2023","journal-title":"F. 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