FDA label
What is famciclovir used for?
The FDA-approved uses of famciclovir, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for famciclovir lists 2 uses: Immunocompetent Adult Patients; HIV-Infected Adult Patients.
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Famciclovir, tablet, film coated
Indications and Usage, quoted from the label by Macleods Pharmaceuticals Limited (ANDA201022). Cross-references to other label sections are left out.
Immunocompetent Adult Patients
Herpes labialis(cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients. Genital herpes: Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established. Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established. Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.
HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are is indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established. Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: • Patients with first episode of genital herpes • Patients with ophthalmic zoster • Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients • Black and African American patients with recurrent genital herpes
Source: DailyMed label, set id eeeee9c4-8566-4100-8ca4-3df936a3365d, version 14, effective September 17, 2025. NDC 33342-024, one of 26 listings for this product.
Questions
What is famciclovir used for?
The FDA label for famciclovir lists 2 uses: Immunocompetent Adult Patients; HIV-Infected Adult Patients.
What drug class is famciclovir?
FDA lists famciclovir in the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.