Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections

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-risk 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 18-64 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. Skin and subcutaneous tissue connections (15.9%), general disorders and administrations site conditions (12%), and gastrointestinal disorders (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.

Automated summary

This study aimed to characterize the adverse drug reactions (ADR) of the most commonly used antibiotics for upper airway infections in Portugal. The results showed that serious ADR were more likely to occur in female patients and those aged between 18 and 64. Health professionals were the main reporters of suspected serious ADR. Skin and gastrointestinal issues were the prevalent types of ADR.