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. 2021 Sep;19(9):1970-1972.e3.
doi: 10.1016/j.cgh.2021.04.039. Epub 2021 Apr 30.

Hepatobiliary Adverse Drug Reactions Associated With Remdesivir: The WHO International Pharmacovigilance Study

Min Seo Kim  1 , Se Yong Jung  2 , Seung Won Lee  3 , Han Li  4 , Ai Koyanagi  5 , Andreas Kronbichler  6 , Elena Dragioti  7 , Kalthoum Tizaoui  8 , Paul Wasuwanich  4 , Sung Hwi Hong  9 , Ramy Abou Ghayda  10 , Hae Won Yoo  11 , Hanna Kim  12 , Louis Jacob  13 , Joe-Elie Salem  14 , Karel Kostev  15 , Youn Ho Shin  16 , So Young Kim  17 , Gabriele Gamerith  18 , Dong Keon Yon  19 , Jae Il Shin  20 , Lee Smith  21
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Hepatobiliary Adverse Drug Reactions Associated With Remdesivir: The WHO International Pharmacovigilance Study

Min Seo Kim et al. Clin Gastroenterol Hepatol. 2021 Sep.

Abstract

Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.5 However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear.1-4,6 Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.

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