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\begin{document}

\title{Data-mining for~adverse drug reaction signals of macitentan based
on~real-world data: pharmacovigilance study of the FAERS database}



\author[1]{Fan Wu}%
\author[1]{HE ZHU}%
\affil[1]{Affiliation not available}%


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  \date{May 21, 2024}


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\begin{abstract}
Background: The purpose of pharmacovigilance is the timely detection and
identification of harmful drug-related reactions in the clinical
application of drugs to reduce the risk of their clinical use.
Macitentan has been on the market for close to 10 years, during which
time several clinical studies have reported adverse events associated
with macitentan outside of the drug description and uploaded them into
the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting
System.Aim: This study aimed to promote the safe use of macitentan by
mining and analyzing the adverse event signals of macitentan in the
FAERS database.Method: The proportionate disequilibrium method was used
to mine and analyze the FAERS database for macitentan-related adverse
events. Preferred Terms of ADR reports were categorized by System Organ
Class (SOC) based on the Medical Dictionary for Regulatory Activities.
Results: A total of 32,607 macitentan adverse events were retrieved,
and after exclusion by the methodology developed in this study, a total
of 253 positive signals for AEs were obtained, and it was found that
macitentan may have potential new adverse reactions such as blood
potassium decreased(ROR {[}95\% CI{]}= 3.51{[}3.10-3.98{]}), respiratory
failure(ROR {[}95\% CI{]}=4.06{[}3.77-4.39{]}), epistaxis(ROR {[}95\%
CI{]}=2.50{[}2.29-2.73{]}), and other potential adverse reactions in
addition to the adverse reactions that have already been reported in the
specification.Conclusion: Clinical attention is recommended for the new
adverse drug reactions to macitentan detected in this study.%
\end{abstract}%



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