Oropharyngeal Adverse Events to Drugs and Vaccines: Pharmacovigilance Data From Italy (2019–2021)

Abstract

ObjectivesThe aim of this study was to perform a descriptive analysis of oropharyngeal adverse events (AEs) related to drugs and/or vaccines in order to provide useful information for clinicians.MethodsData related to three regions of Italy were analyzed from 2019 to 2021 by using the National Pharmacovigilance database.ResultsAmong overall 67,384 cases, 2773 (4.1%) reported at least one oropharyngeal AE. Most cases referred to females (71.0%) and adults (70.8%). The majority of cases were reported as not serious (68.4%) and the outcome was mainly positive (73.5%). The cases related to drugs (52.2%) were slightly more than those related to vaccines (47.8%), the latter nearly completely represented by COVID‐19 vaccines. Among 3324 oropharyngeal AEs, the most commonly reported were oropharyngeal conditions (65.9%). The most reported AEs related to vaccines were paresthesia oral and oropharyngeal pain, whereas the most reported AEs related to drugs were throat tightness and angioedema. A marked under‐reporting of osteonecrosis of the jaw (2.9%) was observed, despite this risk was well documented in the same country.ConclusionsThis analysis suggested an under‐reporting of oropharyngeal AEs and the need to better train dentists, dental hygienists, and also general practitioners.