Incidence and Factors Associated With Paxlovid-Related Dysgeusia: A Pharmacovigilance Study

ABSTRACT

Introduction: Paxlovid (nirmatrelvir/ritonavir) is a novel, orally administered COVID-19 therapeutic with a reported dysgeusia incidence of 5.6%, based on the initial clinical trial. The purpose of this study is to report the incidence and associated factors of this adverse event following the emergency use authorization of Paxlovid in December 2021, compared with other COVID-19 therapeutics (OCTs), using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Method(s) This retrospective study investigated Paxlovidassociated adverse events (PAE) and OCT adverse events queried from the FAERS database between December 1, 2021, to June 10, 2022. Descriptive statistics were performed on PAE demographic data as well as all causes of dysgeusia. Comparisons of dysgeusia incidence between Paxlovid and OCT were reported using odds ratio, Fischer exact test, and multivariate analyses. Result(s) A total of 6735 PAE and 4251 OCT adverse events were included. Paxlovid accounted for 39.4% of all medication- associated dysgeusia (n=675) between January and March 2022. Paxlovid-associated dysgeusia (PAG) was the most common PAE, with an incidence of 24.84%. PAG was associated with nonserious COVID-19 outcomes (odds ratio [OR]=4.449) and female gender (OR= 1.6), both P<.0001. Compared with OCT, Paxlovid was 12 times more likely to be associated with dysgeusia (OR=12.03;P<.0001). Conclusion(s) Our findings support a strong association between Paxlovid and dysgeusia using a real-world pharmacovigilance database. Specifically, PAG is a highly prevalent occurrence that may be particularly unique to this COVID-19 therapeutic, as compared with others. Gender may also be associated with this event. Additional studies are needed to elucidate the precise mechanism of this common adverse effect.