Association Between Various Dosage Forms of Semaglutide and Ocular Adverse Events in a Real-World Setting

Association Between Various Dosage Forms of Semaglutide and Ocular Adverse Events in a Real-World Setting | 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 Association Between Various Dosage Forms of Semaglutide and Ocular Adverse Events in a Real-World Setting Tao Zhao, Liting Zheng, Yiyun Feng, Min Lao, Yongmei Huang, Guosong Wu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5868396/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Apr, 2025 Read the published version in BMC Ophthalmology → Version 1 posted 7 You are reading this latest preprint version Abstract Background Semaglutide is administered in two formulations: subcutaneous injection and oral ingestion. Although it is recognized for its efficacy, concerns have been raised regarding the association between its prolonged use and the potential risk of ocular diseases. Methods In this study, the Report odds ratio (ROR) technique was employed to detect signals of adverse drug reactions (ADRs) associated with the use of semaglutide. Analysis was conducted on data extracted from the FDA Adverse Event Reporting System (FAERS) database, covering the period from 2004(Q1) through 2024(Q3). This investigation encompasses a descriptive analysis focused on the administration of semaglutide through various routes, encompassing a broad range of demographics including gender (male and female), age groups, along with other demographic data and the timing of disease onset. Following this, the study employs the ROR methodology to assess the differential adverse event signals across distinct semaglutide formulations. Results We categorized the eye as the System Organ Class (SOC) and obtained 1733 ADEs reports related to it from the FAERS database. Of these, 1541 reports were associated with injectables, while tablets were linked to 192 ADE reports. In both dosage forms, most cases occurred within the first month of administration, although the median time to onset (TTO) differed, with injectables identified at 7.00 [IQR 0.00-56.00] days and tablets at only 3.50 [IQR 0.00-35.00] days. It is worth noting that 5.41% of patients administered subcutaneous injections and 2.17% of those receiving oral medications reported ADEs following one year of treatment with semaglutide. Furthermore, female patients exhibited a higher susceptibility to ocular adverse reactions compared to their male counterparts. Regarding the primary preferred terms (PTs), blurred vision constitutes 34.33% of the total ADEs associated with tablet formulations. This incidence is marginally higher than that observed with injectable formulations. This investigation further discerned ocular ADEs signals associated with specific formulations: subcutaneous injections have a higher frequency of reports concerning retinal complications, such as diabetic retinopathy, ischemic optic neuropathy, retinal detachment, retinal tear, and retinal hemorrhage. Conclusion Utilizing data from the FAERS, this investigation meticulously analyzed the ocular safety profile of semaglutide administered in varying dosage forms. Furthermore, it examined the potential disparities in the risk of ocular ADEs associated with these different formulations. Different administration routes Semaglutide Eye disorders Safety analysis Full Text Additional Declarations No competing interests reported. Supplementary Files SupplementaryMaterial.docx Cite Share Download PDF Status: Published Journal Publication published 28 Apr, 2025 Read the published version in BMC Ophthalmology → Version 1 posted Editorial decision: Accepted 21 Apr, 2025 Reviews received at journal 09 Apr, 2025 Reviewers agreed at journal 07 Apr, 2025 Reviewers agreed at journal 01 Apr, 2025 Reviewers invited by journal 01 Apr, 2025 Submission checks completed at journal 01 Apr, 2025 First submitted to journal 28 Mar, 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. 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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-5868396","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":436782977,"identity":"bb6f69cf-5610-43c2-a485-ab0ee8495b65","order_by":0,"name":"Tao Zhao","email":"","orcid":"","institution":"Baiyun Branch, Nanfang Hospital, Southern Medical University","correspondingAuthor":false,"prefix":"","firstName":"Tao","middleName":"","lastName":"Zhao","suffix":""},{"id":436782978,"identity":"bdfd448e-3eef-44f7-8c25-34794f05c4eb","order_by":1,"name":"Liting Zheng","email":"","orcid":"","institution":"Baiyun Branch, Nanfang Hospital, Southern 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Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Different administration routes, Semaglutide, Eye disorders, Safety analysis","lastPublishedDoi":"10.21203/rs.3.rs-5868396/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5868396/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground\u0026nbsp;Semaglutide is administered in two formulations: subcutaneous injection and oral ingestion. Although it is recognized for its efficacy, concerns have been raised regarding the association between its prolonged use and the potential risk of ocular diseases.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethods\u0026nbsp;In this study, the Report odds ratio (ROR) technique was employed to detect signals of adverse drug reactions (ADRs) associated with the use of semaglutide. Analysis was conducted on data extracted from the FDA Adverse Event Reporting System (FAERS) database, covering the period from 2004(Q1) through 2024(Q3). This investigation encompasses a descriptive analysis focused on the administration of semaglutide through various routes, encompassing a broad range of demographics including gender (male and female), age groups, along with other demographic data and the timing of disease onset. Following this, the study employs the ROR methodology to assess the differential adverse event signals across distinct semaglutide formulations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults\u0026nbsp;We categorized the eye as the System Organ Class (SOC) and obtained 1733 \u0026nbsp;ADEs reports related to it from the FAERS database. Of these, 1541 reports were associated with injectables, while tablets were linked to 192 ADE reports. In both dosage forms, most cases occurred within the first month of administration, although the median time to onset (TTO) differed, with injectables identified at 7.00 [IQR 0.00-56.00] days and tablets at only 3.50 [IQR 0.00-35.00] days. It is worth noting that 5.41% of patients administered subcutaneous injections and 2.17% of those receiving oral medications reported ADEs following one year of treatment with semaglutide. Furthermore, female patients exhibited a higher susceptibility to ocular adverse reactions compared to their male counterparts. Regarding the primary preferred terms (PTs), blurred vision constitutes 34.33% of the total ADEs associated with tablet formulations. This incidence is marginally higher than that observed with injectable formulations. This investigation further discerned ocular ADEs signals associated with specific formulations: subcutaneous injections have a higher frequency of reports concerning retinal complications, such as diabetic retinopathy, ischemic optic neuropathy, retinal detachment, retinal tear, and retinal hemorrhage.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusion Utilizing data from the FAERS, this investigation meticulously analyzed the ocular safety profile of semaglutide administered in varying dosage forms. 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