Decoding Ambrisentan's Risks: A Deep Dive into FAERS Data

Decoding Ambrisentan's Risks: A Deep Dive into FAERS Data | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Decoding Ambrisentan's Risks: A Deep Dive into FAERS Data Liao Jianting, Sitian Li, Qinan Yin, Changli He, Gang Li, Lizhu Han, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7619233/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Objective This article aims to investigate the adverse drug event (ADE) signals associated with ambrisentan, a medication employed in the treatment of pulmonary arterial hypertension (PAH), and to offer guidance for its safe clinical application. Methods ADE reports related to ambrisentan were collected from the U.S. FDA Adverse Event Reporting System (FAERS) database between Q1 2007 and Q2 2024. Data mining was performed utilizing the Reporting Odds Ratio (ROR) method within disproportionality analysis. ADE names were standardized and coded according to the System Organ Class (SOC) and Preferred Term (PT) of the Medical Dictionary for Regulatory Activities (MedDRA) version 26.0. Results A total of 45,007 ADE reports identified ambrisentan as the primary suspect drug. with 74.26% involving female patients, primarily aged 18–65. Notably, the majority of these reports, 85.75%, originated from the United States. The most common patient outcomes were hospitalization (46.19%). A total of 267 positive ADE signals were detected for ambrisentan. Notably, hematotoxicity related ADEs, such as decreased serum iron levels and iron-deficiency anemia, as well as nervous system-related ADEs, including exertional dizziness and syncope, were not documented in the drug's package insert. Additionally, other ADEs, such as elevated human chorionic gonadotropin (hCG) levels, atrial flutter, syncope, and jaw pain, were similarly omitted from the insert. The time-to-onset (TTO) analysis revealed that the majority of positive ADE signals were observed within the initial 0–30 days (9.05%) and beyond than 360 days (10.01%) following the commencement of treatment. Conclusion Our research had conducted a systematic summary of the adverse reactions of ambrisentan and explored the mechanism of its adverse reaction occurrence. We had verified the common adverse reactions of ambrisentan, including peripheral oedema, headache, nasal congestion, liver function impairment, and a strong signal for anemia. Additionally, we had discovered new positive signals of adverse reactions such as palpitations, atrial flutter, syncope, jaw pain, gastrointestinal bleeding, ear congestion, and middle ear effusion. This study provided a systematic elaboration on the adverse reactions of ambrisentan, emphasizing the importance of comprehensive monitoring and management of adverse reactions to ensure patient safety and optimize treatment outcomes. Ambrisentan Pulmonary Arterial Hypertension Adverse Drug Events Signal Detection Disproportionality Analysis Rational Drug Use Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 02 Nov, 2025 Reviewers agreed at journal 16 Oct, 2025 Reviewers invited by journal 10 Oct, 2025 Editor invited by journal 18 Sep, 2025 Editor assigned by journal 17 Sep, 2025 Submission checks completed at journal 17 Sep, 2025 First submitted to journal 15 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7619233","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":533064137,"identity":"48871249-56d9-49fe-969a-4e184c3377d2","order_by":0,"name":"Liao Jianting","email":"","orcid":"","institution":"Personalized Drug Research and Therapy Key Laboratory of Sichuan Province, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of 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Data","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pulmonary-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pulm","sideBox":"Learn more about [BMC Pulmonary Medicine](http://bmcpulmmed.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pulm/default.aspx","title":"BMC Pulmonary Medicine","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Ambrisentan, Pulmonary Arterial Hypertension, Adverse Drug Events, Signal Detection, Disproportionality Analysis, Rational Drug Use","lastPublishedDoi":"10.21203/rs.3.rs-7619233/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7619233/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThis article aims to investigate the adverse drug event (ADE) signals associated with ambrisentan, a medication employed in the treatment of pulmonary arterial hypertension (PAH), and to offer guidance for its safe clinical application.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eADE reports related to ambrisentan were collected from the U.S. FDA Adverse Event Reporting System (FAERS) database between Q1 2007 and Q2 2024. Data mining was performed utilizing the Reporting Odds Ratio (ROR) method within disproportionality analysis. ADE names were standardized and coded according to the System Organ Class (SOC) and Preferred Term (PT) of the Medical Dictionary for Regulatory Activities (MedDRA) version 26.0.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 45,007 ADE reports identified ambrisentan as the primary suspect drug. with 74.26% involving female patients, primarily aged 18\u0026ndash;65. Notably, the majority of these reports, 85.75%, originated from the United States. The most common patient outcomes were hospitalization (46.19%). A total of 267 positive ADE signals were detected for ambrisentan. Notably, hematotoxicity related ADEs, such as decreased serum iron levels and iron-deficiency anemia, as well as nervous system-related ADEs, including exertional dizziness and syncope, were not documented in the drug's package insert. Additionally, other ADEs, such as elevated human chorionic gonadotropin (hCG) levels, atrial flutter, syncope, and jaw pain, were similarly omitted from the insert. The time-to-onset (TTO) analysis revealed that the majority of positive ADE signals were observed within the initial 0\u0026ndash;30 days (9.05%) and beyond than 360 days (10.01%) following the commencement of treatment.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eOur research had conducted a systematic summary of the adverse reactions of ambrisentan and explored the mechanism of its adverse reaction occurrence. We had verified the common adverse reactions of ambrisentan, including peripheral oedema, headache, nasal congestion, liver function impairment, and a strong signal for anemia. Additionally, we had discovered new positive signals of adverse reactions such as palpitations, atrial flutter, syncope, jaw pain, gastrointestinal bleeding, ear congestion, and middle ear effusion. This study provided a systematic elaboration on the adverse reactions of ambrisentan, emphasizing the importance of comprehensive monitoring and management of adverse reactions to ensure patient safety and optimize treatment outcomes.\u003c/p\u003e","manuscriptTitle":"Decoding Ambrisentan's Risks: A Deep Dive into FAERS Data","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-23 23:49:13","doi":"10.21203/rs.3.rs-7619233/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-11-02T21:30:02+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"285792684083822892681650462347763415319","date":"2025-10-17T02:37:04+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-10T08:40:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-09-18T14:43:39+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-17T10:55:22+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-17T10:55:04+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pulmonary Medicine","date":"2025-09-15T10:01:44+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pulmonary-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pulm","sideBox":"Learn more about [BMC Pulmonary Medicine](http://bmcpulmmed.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pulm/default.aspx","title":"BMC Pulmonary Medicine","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f7901e8a-d585-4ebb-b5ca-32b7c3270421","owner":[],"postedDate":"October 23rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-10-23T23:49:13+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-23 23:49:13","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7619233","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7619233","identity":"rs-7619233","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}