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Famciclovir: Side Effects

Famciclovir is an oral prodrug of penciclovir, a selective antiviral drug with activity against Varicella zoster virus, Herpes simplex virus types 1 and 2, and Epstein-Barr virus, as well as human hepatitis B virus.

After oral administration, famciclovir is well absorbed (systemic availability 77%), with little intersubject variability, and is rapidly converted to penciclovir. This compares favorably with aciclovir, the absorption of which is slow and incomplete, with a highly variable systemic availability of only 10-20%.

Comparative studies

In a study of oral famciclovir versus oral aciclovir, designed to demonstrate equivalence of efficacy of the two drugs in the treatment of mucocutaneous Herpes simplex infection in HIV-infected individuals, there was no difference in the incidence or nature of adverse effects in the two groups. None of the withdrawals from the trial was considered by the investigator to be related to the study medication.

Placebo-controlled studies

In an integrated safety analysis of 1607 patients who had taken famciclovir for the treatment of Herpes zoster or genital herpes, famciclovir was extremely well tolerated with an adverse effect profile similar to placebo. Headache, nausea, and diarrhea were the most frequently reported adverse events in those taking both famciclovir and placebo.

In an experimental study of Herpes simplex labialis, adverse events (diarrhea and nausea) occurred with similar frequency with famciclovir and placebo. No laboratory abnormalities were consistently associated with famciclovir.

In a randomized, placebo-controlled study in 455 patients oral famciclovir (125 or 250 mg tds or 250 mg bd) used to suppress recurrent genital Herpes simplex infections, the toxicity profile of famciclovir was comparable to placebo. The only serious adverse effects reported as being possibly related to famciclovir were raised bilirubin concentration and lipase activity in one patient after 10 months of treatment with famciclovir 125 mg tds. However, these laboratory abnormalities resolved on therapy after 7 days and did not recur during the rest of the study.

Organs and Systems


Adverse effects associated with famciclovir have been collected in over 6000 patients in two postmarketing surveillance studies. Only headache, abdominal symptoms, dizziness, vomiting, and diarrhea were associated with the drug. Two prospective trials have confirmed the low frequency of adverse effects, the more common ones being nausea, headache, vomiting, and diarrhea.

Sexual function

Prolonged administration of high dosages of famciclovir has been associated with reversible dose-dependent adverse effects on testicular function in rats and dogs. However, in a double-blind, placebo-controlled trial in which 34 men with recurrent genital herpes took famciclovir 250 mg bd for 18 weeks, there were no significant effects on sperm production or function.

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