Title:Safety Profile of Paxlovid in the Treatment of COVID-19
Volume: 30
Issue: 9
Author(s): Bing Lv, Xin Gao, Guoqiang Zeng, Hui Guo and Faping Li*
Affiliation:
- Department of Urology,
The First Hospital of Jilin University, Changchun 130021, Jilin Province, China
Keywords:
Paxlovid, COVID-19, antiviral drug, FAERS, adverse events, diarrhea.
Abstract:
Background: With the urgent and widespread application of Paxlovid, a novel antiviral drug for
Coronavirus Disease 2019 (COVID-19) in clinical practice, concerns regarding its actual efficacy and safety
have emerged. In order to provide more evidence to support its clinical application, we sought to perform a descriptive
analysis of cases who experienced at least one Paxlovid-related adverse event (AEs) and reported to
the FDA Adverse Event Reporting System (FAERS) in the post-marketing period.
Methods: Individual adverse event reports between January 1, 2022 and September 30, 2022, were downloaded
from the FAERS website. We completed a descriptive study about the safety of Paxlovid in the treatment
of COVID-19. Further, we also analyzed the onset time of Paxlovid-related AEs.
Results: As of 30 September 2022, 16,529 de-duplicated cases were submitted to the FDA, and 5,860
(35.45%) were female. The average age was 58.38 years (S.D. 15.50). Most reports (12,390, 74.96%) were
submitted by consumers and 1,436 (8.68%) concerned serious outcomes. The most frequently reported AEs
were disease recurrence (7,724, 16.23%), dysgeusia (2,877, 6.05%), and diarrhoea (1,448, 3.04%). The median
onset time of Paxlovid-related AEs was 8 days (interquartile range,1-10 days), and most of the cases
(2,629, 19.12%) occurred on the day after Paxlovid initiation.
Conclusion: This study indicates that the most common AEs reported with Paxlovid in post-marketing experience
are consistent with the safety assessment of antiviral drugs. Even without emerging apparent safety concerns,
the incidence of serious outcomes was unexpectedly high, and a few cases of potential new AEs occurred.
