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\begin{document}

\title{Adverse event profiles of drug-induced liver injury caused by
antidepressant drugs: a disproportionality analysis}



\author[1]{Aidou Jiang}%
\author[2]{Chunyan Wei}%
\author[2]{weiwei Zhu}%
\author[2]{Fengbo Wu}%
\author[3]{bin wu}%
\affil[1]{West China Hospital of Sichuan University}%
\affil[2]{Affiliation not available}%
\affil[3]{Sichuan University West China Hospital}%


\vspace{-1em}



  
  \date{May 20, 2024}


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\begin{abstract}
Purpose: To evaluate the drug-induced liver injury (DILI) adverse events
related to antidepressants. Method: Post-marketing cases were obtained
from the United States Food and Drug Administration Adverse Events
Reporting System (FAERS). Disproportionality analyses were conducted by
estimating the reporting odds ratio (ROR) and the information component
(IC). Result: There were a total of 10,355 reported cases of DILI out of
a total of 324,588 cases reported from January 2004 to December 2021.
Among the 42 antidepressants assessed, nefazodone (n = 47, ROR = 7.79,
IC=2.91), fluvoxamine (n = 29, ROR = 4.69, IC=2.20), and clomipramine (n
= 24, ROR = 3.97, IC=1.96), were the top three compounds ranked with the
highest reporting odds of cholestatic injury. Mianserin (n = 3, ROR =
21.46, IC=3.99), nefazodone (n = 264, ROR = 18.67, IC=3.84), and
maprotiline (n = 15, ROR = 5.65, IC=2.39), were the top three compounds
ranked with the highest reporting odds of hepatocellular injury.
Nefazodone (n = 187, ROR = 12.71, IC=0.48), clomipramine (n = 35, ROR =
2.07, IC=0.26), and mirtazapine (n = 483, ROR = 1.96, IC=0.94) were the
top three on drug related severe hepatic disorders. Only nefazodone
detected the signals (n = 48, ROR = 18.64, IC=4.16) in the study of
hepatic faliure. Conclusion: The data mining of FAERS suggested
significant association between DILI and nefazodone. Duloxetine and
clomipramine detected the signals on three categories of DILI besaides
hepatic failure. Moreover, DILI risk on the new generation of
antidepressants should also be taken into consideration.%
\end{abstract}%



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