As the use of newer antifungal agents becomes more widespread, safety issues surrounding their use have become more important. To date, the safety profile of itraconazole has been well defined by its worldwide use in 50 million patients over the past 13 years. Data from clinical practice and clinical trials indicate that the 1-week pulse regimen of itraconazole is well tolerated and associated with a favourable safety profile. Adverse events are generally mild and transient. Furthermore, a dose increase to 400 mg in the pulse regimen has had no adverse impact on safety.