Congestive heart failure associated with itraconazole

Lancet. 2001 Jun 2;357(9270):1766-7. doi: 10.1016/S0140-6736(00)04891-1.


Itraconazole is a synthetic antifungal agent approved in the USA for the treatment of onychomycosis and serious systemic fungal infections. Animal and clinical pharmacology studies suggest negative inotropic effects with itraconazole. Data from the US Food and Drug Administration's Adverse Event Reporting System suggest that use of itraconazole is associated with congestive heart failure. We summarise the details of 58 cases suggestive of congestive heart failure in association with the use of itraconazole. Labelling of itraconazole has been changed to alert physicians to this new finding.

Publication types

  • Letter

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Aged, 80 and over
  • Antifungal Agents / adverse effects*
  • Female
  • Heart Failure / chemically induced*
  • Humans
  • Itraconazole / adverse effects*
  • Male
  • Middle Aged
  • Onychomycosis / drug therapy


  • Antifungal Agents
  • Itraconazole