The safety of famciclovir in patients with herpes zoster

Abstract

Famciclovir is the well-absorbed oral form of the antiherpes agent penciclovir. Safety reports from clinical studies of more than 6500 patients and from spontaneous reports indicate that famciclovir is well tolerated. Safety data have been compiled for 808 patients with herpes zoster from three randomized, double-blind, clinical trials. Overall, 51.6% of the famciclovir-treated patient population were women and 48.4% were men. The patient population ranged in age from 15 to 102 years (mean, 51.8 years), with 55.7% aged 50 years or older. The mean duration of exposure to famciclovir was 6.7 days. Total daily doses ranged from 750 mg to 2250 mg. The most common adverse experiences reported were headache, nausea, and diarrhea. The frequency of adverse experiences and laboratory abnormalities (hematologic, clinical chemistry, and urinalysis variables) was similar in both famciclovir and placebo recipients. Safety data from these three clinical studies demonstrate that famciclovir is well tolerated by patients with herpes zoster and has a safety profile comparable to that of placebo.