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Updated: Sep 5, 2025

Whole Genome Sequencing of Candida glabrata for Detection of Markers of Antifungal Drug Resistance
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Whole Genome Sequencing of Candida glabrata for Detection of Markers of Antifungal Drug Resistance

Published on: December 28, 2017

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Torsade de Pointes/QT Prolongation Associated with Antifungal Triazoles: A Pharmacovigilance Study Based on the U.S.

Zicheng Yu1, Xiaolan Liao1

  • 1Department of Pharmacy, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, China.

Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques
|July 5, 2022
PubMed
Abstract

Insights

Antifungal triazoles can cause fatal Torsade de pointes (TdP)/QT prolongation, with fluconazole showing the strongest signals. This adverse event typically occurs within 14 days of starting triazole therapy.

Area of Science:

  • Pharmacovigilance
  • Cardiology
  • Infectious Diseases

Background:

  • Antifungal triazoles are widely used but associated with serious cardiac adverse events.
  • Torsade de pointes (TdP) and QT prolongation are life-threatening adverse events (AEs) linked to triazole use.

Purpose of the Study:

  • To comprehensively compare the adverse event signals of TdP/QT prolongation among different antifungal triazoles.
  • To analyze the onset time of TdP/QT prolongation associated with antifungal triazoles.

Main Methods:

  • Retrospective analysis of the U.S. FDA Adverse Event Reporting System (FAERS) database.
  • Utilized reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM) to assess AE signals.
  • Compared AE onset times using nonparametric tests.

Main Results:

  • Identified 448 reports of TdP/QT prolongation associated with four antifungal triazoles.
  • Detected significant AE signals for all investigated triazoles, with fluconazole exhibiting the strongest signals.
  • The majority of TdP/QT prolongation events occurred within 0-14 days after initiating triazole therapy.

Conclusions:

  • Antifungal triazoles present intense adverse event signals for TdP/QT prolongation.
  • Close monitoring for TdP/QT prolongation is crucial, especially during the initial 14 days of antifungal triazole treatment.

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