A real‑world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Paxlovid and Molnupiravir

Abstract

Background: Questions have been raised about the safety of paxlovid and molnupiravir as antiviral drugs for the treatment of COVID-19 since the pandemic.

Methods: We applied the FDA Adverse Event Reporting System (FAERS) to assess the safety by performing a disproportionality analysis to identify potential risks of paxlovid and molnupiravir. The protocol does not require ethics committee review because this study is based on a publicly available database.

Results: The number of paxlovid signals was higher than that of molnupiravir, with most signals of these two drugs overlapped. General disorders and administration site conditions (ROR: 0.52, 95% CI: 0.58- 2.18), infections and infestations (ROR: 0.18, 95% CI: 0.23-6.64), nervous system disorders (ROR: 1.41, 95% CI: 0.79-1.58) were the top 3 signals for paxlovid, with gastrointestinal disorders (ROR: 4.13, 95% CI: 0.27-4.54), skin and subcutaneous tissue disorders (ROR: 11.51, 95% CI: 0.10-12.92), nervous system disorders (ROR: 1.41, 95% CI: 0.79-1.58) for molnupiravir. Paxlovid-induced infections, skin and subcutaneous tissue disorders, and molnupiravir-induced musculoskeletal and connective tissue disorders, as well as potential safety signals on the heart, eyes and ears needlong-term observation, especially for signals not included in the instructions. However, it is important to note that these are all potential safety signals, and more research is needed to confirm whether these drugs are actually associated with these risks.

Conclusion: The adverse events on this study confirms most of the instructional information for paxlovid and molnupiravir, both drugs need to be monitored for risk signals such as acute respiratory failure, hematologic and lymphatic system.