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

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

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenosine Monophosphate / analogs & derivatives
  • Adverse Drug Reaction Reporting Systems
  • Alanine / analogs & derivatives
  • COVID-19 Drug Treatment*
  • Databases, Factual
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Humans
  • Pharmacovigilance
  • SARS-CoV-2
  • World Health Organization

Substances

  • remdesivir
  • Adenosine Monophosphate
  • Alanine