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Historically, warfarin has played a significant role in this context. In recent years, introduction of new oral anticoagulants, such as rivaroxaban, apixaban, dabigatran, and edoxaban, has been seen. This study evaluates the risk associated with the use of oral anticoagulants by analyzing spontaneous adverse drug reactions reported to the Portuguese Pharmacovigilance System from 2012 to 2021. The study includes 951 adverse drug reactions reports, with the majority (<jats:italic>n<\/jats:italic>\u2009=\u2009770; 80.97%) classified as serious. Of the 770 serious adverse drug reactions reports, the most commonly reported seriousness criterion was \u201cClinically Important\u201d (<jats:italic>n<\/jats:italic>\u2009=\u2009350; 45.45%). In terms of demographics, there was a higher reporting rate among the elderly population, with a greater prevalence of females. The System Organ Class group with the highest number of adverse drug reactions was \u201cGastrointestinal disorders,\u201d with the most commonly reported Preferred Term being \u201cGastrointestinal hemorrhage,\u201d and dabigatran was the most frequently reported drug. In summary, oral anticoagulants have adverse drug reactions that require continuous monitoring. Accurate identification and monitorization of adverse drug reactions is an important starting point to improve drug safety in population.<\/jats:p>","DOI":"10.1002\/prp2.1235","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T10:55:39Z","timestamp":1726656939000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Risks of oral anticoagulants: Analysis of adverse drug reactions reported to the Portuguese National Pharmacovigilance System"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-5597-2269","authenticated-orcid":false,"given":"Ana Sofia","family":"Martins","sequence":"first","affiliation":[{"name":"Health Sciences Faculty University of Beira Interior  Covilh\u00e3 Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5225-6222","authenticated-orcid":false,"given":"Cristina","family":"Monteiro","sequence":"additional","affiliation":[{"name":"UFBI\u2010 Pharmacovigilance Unit of Beira Interior University of Beira Interior  Covilh\u00e3 Portugal"},{"name":"CISCS\u2010UBI\u2010 Health Sciences Research Centre University of Beira Interior  Covilh\u00e3 Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3333-5977","authenticated-orcid":false,"given":"Ana Paula","family":"Duarte","sequence":"additional","affiliation":[{"name":"UFBI\u2010 Pharmacovigilance Unit of Beira Interior University of Beira Interior  Covilh\u00e3 Portugal"},{"name":"CISCS\u2010UBI\u2010 Health Sciences Research Centre University of Beira Interior  Covilh\u00e3 Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,18]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.20344\/amp.85"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.836"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ancv.2016.08.001"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.32385\/RPMGF.V24I4.10527"},{"key":"e_1_2_13_6_1","unstructured":"FurtadoC SilvaA.Anticoagulants 2000\u20102013.2014. 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