{"id":7365,"date":"2026-04-02T05:43:58","date_gmt":"2026-04-02T05:43:58","guid":{"rendered":"https:\/\/www.merckconnect.com\/winrevair\/?page_id=7365"},"modified":"2026-04-02T10:43:08","modified_gmt":"2026-04-02T10:43:08","slug":"nct04576988-adverse-reactions","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/winrevair\/nct04576988-adverse-reactions\/","title":{"rendered":"Adverse reactions"},"content":{"rendered":"<link rel='stylesheet' id='vivid360-spacer-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/spacer\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-top mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-columns is-not-stacked-on-mobile is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"column-wrapper _258a626d-e08a-4e9a-838a-384a0433783f\"><style>\n\t\t\t\t@media (min-width: 1024px) {\n\t\t\t\t\t.column-wrapper {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 1024px) {\n\t\t\t\t\t#block-258a626d-e08a-4e9a-838a-384a0433783f,\n\t\t\t\t\t._258a626d-e08a-4e9a-838a-384a0433783f {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.wp-block-columns:not(.is-not-stacked-on-mobile)>.column-wrapper {\n\t\t\t\t\t\tflex-basis: 100% !important;\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 767px) {\n\t\t\t\t\t#block-258a626d-e08a-4e9a-838a-384a0433783f,\n\t\t\t\t\t._258a626d-e08a-4e9a-838a-384a0433783f {\n\t\t\t\t\t\tflex-basis: 25% !important;display: unset !important;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t<\/style><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:8%\"><link rel='stylesheet' id='vivid360-image-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"wp-block-vivid360-image img-container mb-0 ml-0 mt-0 mr-0\"><figure class=\"wp-block-vivid360-image is-style-default size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/STELLAR-icon-1.svg\" alt=\"\" class=\"wp-image-7349  style-noshadow   \" width=\"80\" height=\"80\" style=\"height:80px;width:80px\"\/><\/figure><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"column-wrapper _3b8bc86c-f311-4157-896f-471010948715\"><style>\n\t\t\t\t@media (min-width: 1024px) {\n\t\t\t\t\t.column-wrapper {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 1024px) {\n\t\t\t\t\t#block-3b8bc86c-f311-4157-896f-471010948715,\n\t\t\t\t\t._3b8bc86c-f311-4157-896f-471010948715 {\n\t\t\t\t\t\tdisplay: contents;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.wp-block-columns:not(.is-not-stacked-on-mobile)>.column-wrapper {\n\t\t\t\t\t\tflex-basis: 100% !important;\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t@media (max-width: 767px) {\n\t\t\t\t\t#block-3b8bc86c-f311-4157-896f-471010948715,\n\t\t\t\t\t._3b8bc86c-f311-4157-896f-471010948715 {\n\t\t\t\t\t\tflex-basis: 75% !important;display: unset !important;\n\t\t\t\t\t\t\n\t\t\t\t\t}\n\t\t\t\t\t.column-wrapper .wp-block-column {\n\t\t\t\t\t\torder: inherit;\n\t\t\t\t\t}\n\t\t\t\t}\n\t\t\t\t<\/style><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:92%\"><link rel='stylesheet' id='vivid360-heading-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/heading\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid360-heading\" id=\"a69faf8b9-09e5-4e49-b7b5-4ab3f2bae44e\"><h3 class=\"has-primary-color content-width fontWeightRegular\" style=\"--desktopFontSize:18px;--tabletFontSize:16px;--mobileFontSize:16px;--desktopLineHeightSize:27px;--tabletLineHeightSize:24px;--mobileLineHeightSize:\" id=\"\"><strong>In STELLAR, a 24-week study of adults with PAH (WHO FC II or III) on background therapy:<\/strong><\/h3><\/div>\n\n\n\n<div class=\"vivid360-heading\" id=\"a5b737a44-5fa5-4adb-a226-5053b2340cec\"><h1 class=\"has-primary-color content-width fontWeightBold\" style=\"--desktopFontSize:30px;--tabletFontSize:24px;--mobileFontSize:24px;--desktopLineHeightSize:45px;--tabletLineHeightSize:36px;--mobileLineHeightSize:\" id=\"\"><strong>Adverse reactions \u226510% in patients receiving WINREVAIR<sup>TM<\/sup> (sotatercept-csrk)<\/strong> <strong>and at least 5% more than placebo in STELLAR<\/strong><sup>a<\/sup><\/h1><\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:16px;--mobile-spacer:16px;--tablet-spacer:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n\n<figure class=\"wp-block-flexible-table-block-table\"><table class=\"has-fixed-layout\" style=\"border-color:#afb1b4;border-width:1px\"><thead><tr><th style=\"text-align:center;background-color:#ecf1e5;color:#3b3b3c;border-color:#afb1b4;font-size:16px;width:47%;padding-top:19px;padding-bottom:19px\"><strong>Adverse reaction<\/strong><\/th><th style=\"text-align:center;background-color:#f6e3df;color:#3b3b3c;border-color:#afb1b4;font-size:16px;width:34%\"><strong>WINREVAIR <span class=\"no-wrap-text\">(n=163)<\/span><\/strong><\/th><th style=\"text-align:center;color:#3b3b3c;background-color:#f1f2f2;border-color:#afb1b4;font-size:16px;width:29%\"><strong>Placebo <span class=\"no-wrap-text\">(n=160)<\/span><\/strong><\/th><\/tr><\/thead><tbody><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong>Headache<\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">40 (24.5%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">28 (17.5%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Epistaxis<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">36 (22.1%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">3 (1.9%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Rash<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">33 (20.2%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">13 (8.1%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Telangiectasia<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">27 (16.6%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">7 (4.4%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Diarrhea<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">25 (15.3%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">16 (10.0%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Dizziness<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">24 (14.7%)<\/td><td style=\"background-color:#f1f2f2;color:#3b3b3c;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">10 (6.3%)<\/td><\/tr><tr><td style=\"color:#3b3b3c;text-align:center;font-size:16px;border-color:#afb1b4;border-width:0.4px\"><strong><strong>Erythema<\/strong><\/strong><\/td><td style=\"font-size:16px;text-align:center;background-color:#f6e3df;color:#3b3b3c;border-width:0.4px;border-color:#afb1b4\">22 (13.5%)<\/td><td style=\"color:#3b3b3c;background-color:#f1f2f2;font-size:16px;text-align:center;border-width:0.4px;border-color:#afb1b4\">5 (3.1%)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_e9befdb7-6db6-42ee-8c80-368951822c92 \" id=\"\"><p class=\"has-dark-text-color has-text-color has-regular-font-size\">The median duration of treatment was 273 days in the placebo group and 313 days in the WINREVAIR group.<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n\n<div class=\"paragraph-wrapper\"><div class=\"_e98c80a5-813b-4efc-ab83-5b8fef799c10 \" id=\"\"><p class=\"has-dark-text-color has-text-color has-small-font-size\"><sup>a<\/sup>Double-blind placebo-controlled period + long-term double-blind period of STELLAR.<\/p><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:32px;--tablet-spacer:24px;--mobile-spacer:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-image-module-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/image-module\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-image-module ratio-50-50 content-above one-col full-page-width\"><div class=\"vivid360-block-image-module__content-wrapper content-align-left\" id=\"contentDiv\"><\/div><figure class=\"vivid360-block-image-module__image-container\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Row.png?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2.png?w=1440\"\/><img decoding=\"async\" width=\"936\" height=\"87\" data-src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2.png\" loading=\"lazy\" src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2026\/04\/Adverse_reactions_numbers-2.png\" alt=\"WINREVAIR Had a Low Rate of Discontinuation Due To Adverse Reactions: 4% On WINREVAIR vs 7% On Placebo\"\/><\/picture><figcaption class=\"caption-align-left noCaptionText\" id=\"figcaption\"><p class=\"caption-title vivid360-block-image-module__caption\" style=\"--captionFontSize:14px;--captionFontSizeTablet:14px;--captionFontSizeMobile:14px\"><\/p><\/figcaption><\/figure><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:8px;--mobile-spacer:16px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"vivid360-heading default-hcp-fontsize default-hcp-tablet-fontsize default-hcp-mobile-fontsize\" id=\"ac0479fc5-136b-4d36-845b-df1aabcf0aa0\"><h2 class=\"content-width fontWeightRegular\" style=\"--desktopFontSize:var(--h2FontSizeDesktop);--tabletFontSize:var(--h2FontSizeDesktop);--mobileFontSize:var(--h2FontSizeMobile);--desktopLineHeightSize:var(--h2LineHeightDesktop);--tabletLineHeightSize:var(--h2LineHeightDesktop);--mobileLineHeightSize:\" id=\"\"><strong>Long-term safety data for WINREVAIR were generally similar to STELLAR data<\/strong><\/h2><\/div>\n\n\n\n<div style=\"background-color:transparent;height:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer spacer-8\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-list-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/list\/css\/style.min.css?ver=1766071753' media='all' \/>\n\n<div class=\"vivid-block-list content-width default-list block-f29f55b3-4606-4eb4-99bf-026836cd89b0 has-regular-font-size\" data-image=\"\" data-image-mobile=\"\" data-image-all=\"\" data-image-all-mobile=\"\" data-icon-color=\"#333\" data-text-color=\"#333\" data-client-id=\"block-f29f55b3-4606-4eb4-99bf-026836cd89b0\"><ul class=\"first-level\"><li>PULSAR was a multicenter, randomized, double-blind, phase 2 trial that included a 24-week placebo-controlled treatment period, followed by an 18-month active-drug extension period.<\/li><li>The safety profile in the long-term uncontrolled extension period of the PULSAR study was generally similar to that observed in the STELLAR study. Patients were treated with WINREVAIR 0.3 mg\/kg or 0.7 mg\/kg (n=104) and had a mean duration of exposure of 151 weeks (maximum 218 weeks).<\/li><li>Intrapulmonary Right-to-Left Shunting: Cases of intrapulmonary right-to-left shunting have been reported in a clinical trial with WINREVAIR. In SOTERIA, an ongoing open-label study of the long-term safety and efficacy of WINREVAIR, right-to-left intrapulmonary shunting has been reported in 2 participants (&lt;0.5%) who developed worsening hypoxemia despite improved PAH hemodynamics. Post-marketing cases have also been reported.\u2028<\/li><li>Partial to complete improvement in oxygenation has been observed following discontinuation of WINREVAIR.<span class=\"no-wrap-text\">&nbsp;<\/span><\/li><\/ul><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--mobile-spacer:8px;--tablet-spacer:24px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-mobile vivid360-spacer-tablet\"><\/div>\n\n\n<link rel='stylesheet' id='vivid360-card-css-css' href='https:\/\/www.merckconnect.com\/winrevair\/wp-content\/themes\/cex-wpvip-mhh-merck-vivid360-theme-1-12\/blocks\/card\/css\/style.min.css?ver=1773241827' media='all' \/>\n\n<div id=\"\" class=\"wp-block-vivid360-card ab1a0286e-605a-4f70-bc90-25457991ce40 vivid360-block-card has-text-align-left card-horizontal has-secondary-2-color has-dark-text-border-color has-error-light-bgr-background-color content-width\" style=\"border-width:0px;border-style:;border-radius:0\"><div class=\"card-media \"><figure class=\"ratio-4-3 ratio-1-1-mobile\"><picture><source media=\"(max-width: 767px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2025\/07\/image_03_301e9b.png?w=767\"\/><source media=\"(min-width: 768px) and (max-width: 1440px)\" data-srcset=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2025\/07\/arrow_2.svg?w=1440\"\/><img decoding=\"async\" width=\"90\" height=\"87\" data-src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2025\/07\/arrow_2.svg\" loading=\"lazy\" src=\"https:\/\/www.merckconnect.com\/winrevair\/wp-content\/uploads\/sites\/112\/2025\/07\/arrow_2.svg\" alt=\"\"\/><\/picture><\/figure><\/div><div class=\"card-content\"><div class=\"card-content-wrap\"><h4 class=\"card-header fontWeightBold\">WINREVAIR is a PAH treatment with a demonstrated tolerability profile on top of a broad range of background therapies<\/h4><\/div><\/div><\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:24px;--tablet-spacer:8px;--mobile-spacer:8px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n\n\n\n<div class=\"wp-block-columns mb-0 is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"vivid360-heading\" id=\"a94e4986d-6f55-40c7-ae3b-6472ff3dbdb9\"><h6 class=\"has-primary-color has-text-align-left has-error-light-bgr-background-color content-width fontWeightRegular padding-top-bottom10 mt-0 mb-0 padding-left-right15\" style=\"--desktopFontSize:16;--tabletFontSize:16;--mobileFontSize:16;--desktopLineHeightSize:24px;--tabletLineHeightSize:24px;--mobileLineHeightSize:;--tabletAlign:left;--mobileAlign:left\" id=\"\"><strong>Report exposure during pregnancy or lactation to the <span class=\"no-wrap-text\">Merck Sharp &amp; Dohme<\/span> LLC Adverse Event reporting line at <span class=\"no-wrap-text\">1-877-888-4231<\/span><\/strong><\/h6><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:70px\"><\/div>\n<\/div>\n\n\n\n<div style=\"background-color:transparent;--desktop-spacer:32px;--tablet-spacer:0px;--mobile-spacer:0px\" class=\"wp-block-vivid360-spacer vivid360-spacer-desktop vivid360-spacer-tablet vivid360-spacer-mobile\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The median duration of treatment was 273 days in the placebo group and 313 days in the WINREVAIR group. aDouble-blind placebo-controlled period&#8230;<\/p>\n","protected":false},"author":4249,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[],"ga4_page_businessunit":[],"ga4_page_campaign":[],"ga4_page_content_purpose":[],"ga4_page_customer_journey_stage":[],"ga4_page_customer_specialty":[],"ga4_page_experience":[],"ga4_page_indication":[],"ga4_page_material_intent":[],"ga4_page_product":[],"ga4_page_region":[],"ga4_page_therapeuticarea":[],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-7365","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Adverse Reactions From a Phase III Clinical Trial for WINREVAIR\u2122 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