{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T11:44:00Z","timestamp":1768563840476,"version":"3.49.0"},"reference-count":52,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2022,4,2]],"date-time":"2022-04-02T00:00:00Z","timestamp":1648857600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001871","name":"Funda\u00e7\u00e3o para a Ci\u00eancia e Tecnologia","doi-asserted-by":"publisher","award":["PTDC\/SAU-SER\/31678\/2017"],"award-info":[{"award-number":["PTDC\/SAU-SER\/31678\/2017"]}],"id":[{"id":"10.13039\/501100001871","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit\u2013risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18\u201364 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. \u201cSkin and subcutaneous tissue connections\u201d (15.9%), \u201cgeneral disorders and administrations site conditions\u201d (12%), and \u201cgastrointestinal disorders\u201d (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR.<\/jats:p>","DOI":"10.3390\/antibiotics11040477","type":"journal-article","created":{"date-parts":[[2022,4,3]],"date-time":"2022-04-03T02:59:52Z","timestamp":1648954792000},"page":"477","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections"],"prefix":"10.3390","volume":"11","author":[{"given":"Joana","family":"Ferreira","sequence":"first","affiliation":[{"name":"NOVA Medical School, Faculty of Medical Sciences, New University of Lisbon (NMS|FCM UNL), 1169-056 Lisbon, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2316-6770","authenticated-orcid":false,"given":"Ana Isabel","family":"Placido","sequence":"additional","affiliation":[{"name":"Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG), 6300-559 Guarda, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1051-8084","authenticated-orcid":false,"given":"Vera","family":"Afreixo","sequence":"additional","affiliation":[{"name":"Center for Research & Development in Mathematics and Application (CIDMA), University of Aveiro, 3810-193 Aveiro, Portugal"}]},{"given":"In\u00eas","family":"Ribeiro-Vaz","sequence":"additional","affiliation":[{"name":"Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto, 4200-450 Porto, Portugal"},{"name":"Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine, University of Porto, 4200-450 Porto, Portugal"},{"name":"MEDCIDS\u2014Department of Community Medicine, Health Information and Decision, Faculty of Medicine, University of Porto, 4200-450 Porto, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0169-3788","authenticated-orcid":false,"given":"F\u00e1tima","family":"Roque","sequence":"additional","affiliation":[{"name":"Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG), 6300-559 Guarda, Portugal"},{"name":"Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilh\u00e3, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0500-4049","authenticated-orcid":false,"given":"Maria Teresa","family":"Herdeiro","sequence":"additional","affiliation":[{"name":"Institute of Biomedicine, Department of Medical Sciences, University of Aveiro, 3810-193 Aveiro, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2022,4,2]]},"reference":[{"key":"ref_1","unstructured":"Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare (2022, January 06). 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