Evigrade

Famciclovir

AEMPS

Antiviral nucleoside analogue for herpes infections (HSV-1, HSV-2, VZV)

ATC code: J05AB09

Brand names: Famvir

Updated · Methodology

Indications

A

Genital herpes

First line

For genital herpes, famciclovir is used for the primary episode (250 mg three times daily for 5 days) and recurrences (1000 mg twice daily for 1 day or 125 mg twice daily for 5 days). With frequent recurrences (≥6 episodes per year) 2023 recommends suppressive therapy: 250 mg twice daily for 6–12 months, with periodic review. Treatment within 24 hours of recurrence shortens the episode by 1–2 days.

ICD-10: A60 · ICD-11: 1A94.0

A

Herpes zoster

First line

Famciclovir is first-line for herpes zoster in adults. AEDV 2021 and recommend starting therapy within 72 hours of rash onset: 500 mg three times daily for 7 days. Early treatment shortens rash duration, reduces postherpetic neuralgia risk and acute pain. Treatment is mandatory in ophthalmic zoster, second trigeminal branch involvement and immunocompromised patients.

ICD-10: B02 · ICD-11: 1E91

B

Cold sores (herpes labialis)

Second line

For recurrent herpes labialis, famciclovir is used as a single-day 1500 mg oral regimen. The Spruance 2006 RCT showed the episode shortens by about 1 day on average (NNT about 10), provided the dose is taken in the prodromal phase (tingling, burning before vesicles appear). If lesions are already established, efficacy is much lower. AEDV positions famciclovir as an alternative to valaciclovir; first line for moderate episodes is topical 1% penciclovir cream.

ICD-10: B00.1 · ICD-11: 1F00.01

B

Postherpetic neuralgia

Adjunct

Early famciclovir in the first 72 hours of herpes zoster reduces the frequency and duration of postherpetic neuralgia. Fewer patients report pain at 3 and 6 months compared with placebo. Once postherpetic neuralgia is established (pain beyond 3 months after rash), famciclovir does not treat it – neuropathic pain drugs are needed (gabapentin, pregabalin, amitriptyline) or 8% capsaicin and 5% lidocaine patches.

ICD-10: B02.2 · ICD-11: 1E91.5

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Cold and flu prevention or treatment

Not recommended

Famciclovir is a nucleoside analogue active against herpesviruses (HSV-1, HSV-2, VZV). It has no activity against rhinoviruses, adenoviruses, parainfluenza, RSV, influenza viruses or SARS-CoV-2 – these viruses lack the thymidine kinase needed to activate famciclovir. The marketing position of famciclovir as a «broad-spectrum antiviral» or «immunomodulator for colds» in the labelling of some Russian generics and in pharmacy advertising is misleading. , AEDV, AEMPS and approved the drug only for the treatment of herpes infections. If famciclovir was prescribed for cold, flu or to «boost immunity», consider seeking a second opinion.

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Prodrug: after oral intake, rapidly deacetylated and oxidised to active penciclovir. In herpes-infected cells, penciclovir is phosphorylated by viral thymidine kinase to penciclovir triphosphate, a competitive inhibitor of viral DNA polymerase. It suppresses replication of HSV-1, HSV-2 and VZV. Oral bioavailability about 77%, three to five times higher than aciclovir. Intracellular half-life of the active metabolite is 7–20 hours, allowing 2–3 daily dosing. No activity against respiratory viruses (rhinoviruses, adenoviruses, parainfluenza, influenza, RSV, SARS-CoV-2).

Safety

Contraindications

  • Hypersensitivity to famciclovir, penciclovir or excipients
  • Severe renal impairment without dose adjustment

Serious adverse effects

  • Acute kidney injury, especially with dehydration and concurrent nephrotoxic drugs
  • Thrombocytopenia and neutropenia
  • Confusion and hallucinations in older adults and renal impairment
  • Severe cutaneous reactions (Stevens-Johnson, toxic epidermal necrolysis) – very rare

Common adverse effects

  • Headache
  • Nausea
  • Diarrhoea
  • Rash and itching
  • Fatigue

Pregnancy: can you take Famciclovir?

AEMPS summary of product characteristics (section 4.6): data on famciclovir in pregnant women are limited (fewer than 300 pregnancy outcomes). A cumulative analysis of prospective and retrospective cases found no evidence that the drug causes any specific fetal defect or congenital anomaly. Animal studies showed no embryotoxic or teratogenic effects of famciclovir or penciclovir, its active metabolite. Famciclovir is used during pregnancy only when the potential benefits of treatment outweigh the potential risks.

Breastfeeding: can you take Famciclovir?

Hale L3. Active penciclovir transfers into milk at concentrations similar to maternal plasma, but no clinical adverse effects in infants have been described. Short courses for zoster or genital herpes are compatible; valaciclovir or aciclovir are preferred for suppressive therapy because more data are available.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions5 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «Potential for Other Drugs to Affect Penciclovir: No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after…»

    FDA, section 7 · Open on DailyMed

  • antacidsclass named in the label
    «Potential for Other Drugs to Affect Penciclovir: No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after…»

    FDA, section 7 · Open on DailyMed

  • «Potential for Famciclovir to Affect Other Drugs: The steady-state pharmacokinetics of digoxin were not altered by concomitant administration of multiple doses of famciclovir (500 mg three times…»

    FDA, section 7 · Open on DailyMed

  • «Potential for Other Drugs to Affect Penciclovir: No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after…»

    FDA, section 7 · Open on DailyMed

  • «Potential for Other Drugs to Affect Penciclovir: No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Famciclovir used for?

Famciclovir is evaluated for the following indications with varying evidence strength: Herpes zoster (evidence tier A), Genital herpes (evidence tier A), Cold sores (herpes labialis) (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Famciclovir?

Common side effects of Famciclovir (≥ 1 in 100): Headache, Nausea, Diarrhoea, Rash and itching, Fatigue. See the Safety section for uncommon and serious reactions.

Is Famciclovir safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): data on famciclovir in pregnant women are limited (fewer than 300 pregnancy outcomes). A cumulative analysis of prospective and retrospective cases found no evidence that the drug causes any specific fetal defect or congenital anomaly. Animal studies showed no embryotoxic or teratogenic effects of famciclovir or penciclovir, its active metabolite. Famciclovir is used during pregnancy only when the potential benefits of treatment outweigh the potential risks.

Is Famciclovir compatible with breastfeeding?

Hale L3. Active penciclovir transfers into milk at concentrations similar to maternal plasma, but no clinical adverse effects in infants have been described. Short courses for zoster or genital herpes are compatible; valaciclovir or aciclovir are preferred for suppressive therapy because more data are available.

Who should not take Famciclovir?

Famciclovir is contraindicated in: Hypersensitivity to famciclovir, penciclovir or excipients; Severe renal impairment without dose adjustment. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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