{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T11:11:54Z","timestamp":1775560314934,"version":"3.50.1"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T00:00:00Z","timestamp":1745539200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T00:00:00Z","timestamp":1745539200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100006752","name":"Universidade do Porto","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100006752","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pharmacol. Rep"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Molnupiravir, approved for treating mild to moderate COVID-19 in adults, aims to reduce hospitalisation and mortality rates. Although it was withdrawn from the market after the present study was conducted, understanding its long-term effects remains pertinent. We aimed to assess the real-world effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>This prospective, multicenter, noninterventional, postmarketing cohort study enrolled high-risk COVID-19 outpatients with mild to moderate COVID-19, eligible under national prescribing criteria, who initiated molnupiravir within five days of symptom onset and were ineligible for first-line antiviral therapy. Patients were consecutively enrolled from eight Portuguese study sites and monitored for three months. Effectiveness was assessed by all-cause mortality and hospitalisation through day 29. Safety was evaluated by the incidence, severity, and causality of adverse events (AE), coded using MedDRA terminology and assessed via the WHO-UMC system. Data were collected through structured patient questionnaires and electronic health records. Statistical analysis was descriptive; proportions were reported with 95% confidence intervals (CI), and comparisons between groups were performed using appropriate statistical tests.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>By day 29 post-treatment initiation, no deaths were reported (n\u2009=\u20090; 0%; 95%CI\u2009=\u2009[0,26]), and all patients were either at home or institutionalised, with favourable outcomes. Out of the 12 patients enrolled, eight (67%; 95%CI\u2009=\u2009[35,90]) reported at least one AE, with the median time to the first AE being five days (range 5\u20137\u00a0days). Half of the patients (n\u2009=\u20096; 95%CI\u2009=\u2009[21,79]) reported AE deemed possibly or probably related to molnupiravir, involving nausea (25%), dizziness (17%), bitter taste (17%), and headache (17%). These AE were more commonly observed in older individuals and those overweight, indicating a potential influence of these factors on AE occurrence.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Molnupiravir appears to show good safety and effectiveness, offering an alternative for high-risk COVID-19 outpatients ineligible for first-line therapy. Despite its market withdrawal, ongoing research into its long-term effects is crucial to potentially repurpose it for other viral infections.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s43440-025-00729-2","type":"journal-article","created":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T02:52:57Z","timestamp":1745549577000},"page":"1088-1099","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Post-marketing surveillance study on the effectiveness and safety of molnupiravir in high-risk COVID-19 outpatients: a prospective case series study"],"prefix":"10.1007","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6517-6021","authenticated-orcid":false,"given":"Renato","family":"Ferreira-da-silva","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0009-0000-7221-7856","authenticated-orcid":false,"given":"Lurdes","family":"Silva","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7109-1101","authenticated-orcid":false,"given":"Cristina","family":"Costa-Santos","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9509-0613","authenticated-orcid":false,"given":"Manuela","family":"Morato","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0133-7217","authenticated-orcid":false,"given":"Jorge Junqueira","family":"Pol\u00f3nia","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3442-8158","authenticated-orcid":false,"given":"In\u00eas","family":"Ribeiro-Vaz","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0009-0008-8759-1486","authenticated-orcid":false,"given":"Manuela","family":"Pinto","sequence":"additional","affiliation":[]},{"given":"Marta","family":"Pereira","sequence":"additional","affiliation":[]},{"given":"In\u00eas Marques","family":"Figueira","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2604-9369","authenticated-orcid":false,"given":"Sofia","family":"Baptista","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3243-1617","authenticated-orcid":false,"given":"Helena","family":"Farinha","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2860-061X","authenticated-orcid":false,"given":"F\u00e1tima","family":"Falc\u00e3o","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9668-7561","authenticated-orcid":false,"given":"Ana","family":"Mirco","sequence":"additional","affiliation":[]},{"given":"Liliana","family":"Calixto","sequence":"additional","affiliation":[]},{"given":"Madalena","family":"Melo","sequence":"additional","affiliation":[]},{"name":"ESOA-19 Research Team","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2025,4,25]]},"reference":[{"issue":"1","key":"729_CR1","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1186\/s43141-022-00353-0","volume":"20","author":"A Sezer","year":"2022","unstructured":"Sezer A, Halilovi\u0107-Alihod\u017ei\u0107 M, Vanwieren AR, et al. 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