(348) Olfactory-related adverse events: an analysis of the FDA Reporting System

Introduction: Olfactory dysfunction recently gained considerable interest with its association with the coronavirus pandemic, however, olfactory-related adverse events (ORAEs) associated with medications are potentially under-reported. This study aims to identify and classify medications with patient and provider-reported olfactory-related adverse events using the FDA Adverse Event Reporting System (FAERS) database. Additionally, we aim to describe the association of olfactory associated adverse effects with differences in patient demographics including gender and country of origin.

Methods: This study was a retrospective cross-sectional review of ORAEs reported in the FAERS database from 8/2012 to 8/2022. Our population of interest included adult cases with olfactory-associated adverse effects (anosmia, parosmia, hyposmia, and olfactory dysfunction) stemming from a single suspected product active ingredient (SPAI), the main determinant variable. We excluded reports with multiple reported SPAIs & olfactory symptoms, and incomplete reports. Other variables of interest were patient age, gender, date of report, and country of origin. Data was presented in both frequencies and percentages.

Results: There were 10,505 reported cases for the study period, with 1111 remaining after fulfilling inclusion/exclusion criteria. A total of 44 suspected product active ingredients (SPAIs) were identified. Across all categories, the most common SPAIs were monoclonal antibodies (281, 25.29%), intranasal steroids (234, 21.06%), immunomodulators (228, 20.52%), intranasal decongestants (82, 7.38%), antibiotics (41, 3.69%), antidepressants (40, 3.60%), and various homeopathic (40, 3.60%).

Conclusions: Using the open-source FAERS database, we found the most common SPAIs to be monoclonal antibodies, intranasal steroids, immunomodulators, intranasal decongestants, antibiotics, antidepressants, and homeopathic medications. Findings from this study may function as an educational resource for both prescribers and patients to help reduce the cost and workup for patients with olfactory dysfunction.