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. 2025 Mar;31(3):993-1005.
doi: 10.1111/odi.15145. Epub 2024 Oct 6.

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

Liberata Sportiello  1   2 , Gaetano La Mantia  3   4   5 , Vera Panzarella  4 , Giuseppe Colella  6 , Simona Potenza  7 , Giacomo Oteri  5 , Laura Sottosanti  7 , Giuseppe Bellavia  8 , Mario Gaio  1   2 , Alessia Zinzi  1   2 , Ilaria Morreale  9 , Gaspare Parrinello  10 , Elisabetta Geninatti  11 , Eleonora Marrazzo  11 , Vittorio Fusco  12 , Annalisa Capuano  1   2 , Giuseppina Campisi  3   13
Affiliations

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

Liberata Sportiello et al. Oral Dis. 2025 Mar.

Abstract

Objectives: The 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.

Methods: Data related to three regions of Italy were analyzed from 2019 to 2021 by using the National Pharmacovigilance database.

Results: Among 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.

Conclusions: This analysis suggested an under-reporting of oropharyngeal AEs and the need to better train dentists, dental hygienists, and also general practitioners.

Keywords: database; dentists; oropharyngeal adverse events; pharmacovigilance; spontaneous reporting.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
(a) Trend of the total number of Individual Case Safety Reports (ICSRs) and ICSRs with O‐AEs or without O‐AEs from 2019 to 2021. (b) Frequency of ICSRs containing at least one O‐AE stratified by drug and vaccine from 2019 to 2021. ICSR, Individual Case Safety Report; O‐AE, oral adverse event.
FIGURE 2
FIGURE 2
“Top twenty” preferred term (PTs) reported in the Individual Case Safety Reports (ICSRs) containing at least one oropharyngeal adverse event (o‐AEs) from 2009 to 2021.
See this image and copyright information in PMC

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