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\begin{document}

\title{Post-Marketing Safety Concerns with Nirmatrelvir: A Disproportionality
Analysis of Spontaneous Reports Submitted to the FDA Adverse Event
Reporting System}



\author[1]{Wei Zhuang}%
\author[2]{Jiabing Xu}%
\author[3]{Ye Wu}%
\author[1]{Jianhui Yang}%
\author[1]{Xiuxian Lin}%
\author[1]{Yufang Liao}%
\author[1]{Jun Wan}%
\author[1]{Lizhu Weng}%
\author[1]{Wanlong Lin}%
\affil[1]{Xiamen University School of Medicine}%
\affil[2]{Fujian University of Traditional Chinese Medicine}%
\affil[3]{The First Affiliated Hospital of Xiamen University}%


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  \date{May 19, 2024}


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\begin{abstract}
Aim: Nirmatrelvir as a new 3CL protease inhibitor for treating COVID-19
drug of antiviral drug, the potential side effects have not yet been
fully studied yet. The aim of this study was to identify potential risk
of Nirmatrelvir by analyzing post-marketing safety data based on the
largest publicly available worldwide pharmacovigilance database.
Methods: We analyzed Nirmatrelvir adverse events to detect and
characterize relevant safety signals based on the FDA Adverse Event
Reporting System database in 2022. Case/non-case approach were used to
estimate the reporting odds ratio (ROR) and information component (IC)
with relevant confidence intervals (95\% CI) for AEs with [?]4 counts.
Results: Total of 26846 cases were included. Disease recurrence
{[}ROR(95\%CI)=413.2(395.6-431.59){]}, dysgeusia
{[}ROR(95\%CI)=110.84(106.04-115.85){]}, anosmia
{[}ROR(95\%CI)=15.21(12.76-18.11){]}, ageusia
{[}ROR(95\%CI)=9.80(8.50-11.3){]} and urticaria
{[}ROR(95\%CI)=1.91(1.69-2.17){]} were the main safety signals. In
addition, abdominal pain upper and skin toxicity were two specific
safety signals of Nirmatrelvir. In pregnant population, a significant
increased ROR was found in life-threatening
{[}ROR(95\%CI)=5.12(1.38-19.00){]}. Conclusion: We identified that
disease recurrence, dysgeusia, abdominal pain upper and skin toxicity
were the main and specific safety signals of Nirmatrelvir. Clinician and
pharmacist should pay attention on these AEs. Notably, a potential risk
of Nirmatrelvir in pregnant population should be alerted.%
\end{abstract}%



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