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Famciclovir

Famciclovir is a brand of Famciclovir.

Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1.

Checked against the official label · Updated

MEDICAMENTO SUJEITO A RECEITA MÉDICA Oral Alertas de segurança registados

Famciclovir: quick answers

Used for
Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent.
Usual adult dose
Adult Patients Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes Suppressive therapy Herpes Zoster (shingles) 1000 mg twice daily for 1 day 250 mg twice daily 500 mg every 8 hours for 7 days HIV-Infected.
Children
With food?
Famciclovir tablets may be taken with or without food.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Jan 2025). Your prescription and pharmacist come first.

How to use Famciclovir

O que diz a bula oficial. Se um médico receitou, siga a receita. Se a bula da sua caixa for diferente, vale a da sua caixa.

Para quem é

Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) • Treatment of recurrent episodes of orolabial or genital herpes 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 tr …

Como tomar e com que frequência
  • Famciclovir tablets may be taken with or without food
  • Immunocompetent Adult Patients Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes Suppressive therapy Herpes Zoster (shingles) 1000 mg twice daily for 1 day 250 mg twice daily 500 mg every 8 hours for 7 days HIV-Infected Adult Patients Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance
  • Dosing Recommendation in Immunocompetent Adult Patients Herpes labialis (cold sores): The recommended dosage of famciclovir tablets
  • For the treatment of recurrent herpes labialis is 1500 mg as a single dose
  • Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., tingling, itching, burning, pain, or lesion)
  • Genital herpes: Recurrent episodes: The recommended dosage of famciclovir tablets
  • For the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day
  • Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion)
  • Suppressive therapy: The recommended dosage of famciclovir tablets for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily
  • Herpes zoster (shingles): The recommended dosage of famciclovir tablets
  • For the treatment of herpes zoster is 500 mg every 8 hours for 7 days
  • Therapy should be initiated as soon as herpes zoster is diagnosed. …
Strengths it comes in

Famciclovir tablets are available in 3 strengths: •125 mg : Off white, round, biconvex, film coated tablets, debossed with 'I' on one side and '50' on the other side • 250 mg: Off white, round, biconvex, film coated tablets, debossed with 'I' on one side and '49' on the other side • 500 mg: Off white, oval, film coated, biconvex tablets, debossed with 'I' on one side and '48' on the other side Tab …

Children
  • The efficacy of famciclovir has not been established
  • In pediatric patients
  • The pharmacokinetic profile and safety of famciclovir (experimental granules mixed with OraSweet ® or tablets) were studied in 3 open-label studies
  • Study 1 was a single-dose pharmacokinetic and safety study in infants 1 month to less than 1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection. …
Older adults

Of 816 patients with herpes zoster in clinical studies who were treated with famciclovir, 248 (30.4%) were greater than or equal to 65 years of age and 103 (13%) were greater than or equal to 75 years of age. No overall differences were observed in the incidence or types of adverse events between younger and older patients. …

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • There is no evidence that famciclovir will affect the ability of a patient to drive or to use machines
  • However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking famciclovir should refrain from driving or operating machinery. …
Talk to a doctor first if
  • Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream)
  • Known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream)
Medicines it may not mix with

Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. (7.2) 7.1 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 daily). No clinically significant effect on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide, or emtricitabine was observed following a single oral dose of 500 mg famciclovir coadministered with zidovudine or emtricitabine. An in vitro study using human liver microsomes suggests that famciclovir is not an inhibitor of CYP3A4enzymes. …

Warnings

Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir for their level of renal function. Reduce dosage in patients with renal impairment. ( 2.3 , 8.6 ) 5.1 Acute Renal Failure Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir for their level of renal function. Dosage reduction is recommended when administering famciclovir to patients with renal impairment [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 )].

Possíveis efeitos colaterais

Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions ( 5 )]. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients treated with famciclovir are headache and nausea. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Available data from pharmacovigilance reports with famciclovir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with untreated herpes simplex virus during pregnancy (see Clinical Considerations). After oral administration, famciclovir (prodrug) is converted to penciclovir (active drug). …

If you take too much

Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by hemodialysis.

Se esquecer uma dose

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-01-09.

How much Famciclovir costs

In other countries

Prices in other countries are not what you will pay where you live; they show how prices compare.

Registered products

United States (FDA)

FamciclovirFAMCICLOVIR 1 kg/kg · Powder · Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
NDC 69875-8015Label
FamciclovirFAMCICLOVIR 500 mg/1 · Tablet, Film Coated · Bryant Ranch Prepack
NDC 71335-2936Label
FamciclovirFAMCICLOVIR 125 mg/1 · Tablet, Film Coated · AvKARE
NDC 73190-091Label
FamciclovirFAMCICLOVIR 500 mg/1 · Tablet, Film Coated · PD-Rx Pharmaceuticals, Inc.
NDC 55289-168Label
FamciclovirFAMCICLOVIR 250 mg/1 · Tablet, Film Coated · AvKARE
NDC 73190-092Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026U.S. FDA Class III
11 Jun 2025 · Macleods Pharmaceuticals Ltd · OngoingPresence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, JadcU.S. FDA Class II
22 Dec 2017 · Hetero Labs Limited Unit V · TerminatedTemperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13U.S. FDA Class II
15 Feb 2017 · AVKARE Inc. · TerminatedFailed impurities/ degradation specifications: Product was above specification for unknown impurities.
Famciclovir active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, CanU.S. FDA Class II
14 Nov 2014 · Attix Pharmaceuticals · TerminatedPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the poten

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Famciclovir

Type the registration number on the pack, or scan it with your camera.

Ou tire fotos da caixa
Restam 3 verificações grátis hoje Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Famciclovir

What is in Famciclovir?

Famciclovir contains Famciclovir. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.

What is Famciclovir used for?

Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) • Treatment o (From the official U.S. FDA label.)

How do I take Famciclovir?

Follow your prescription or the leaflet in your pack. The official label says: Famciclovir tablets may be taken with or without food. Immunocompetent Adult Patients ( 2.1 ) Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes Suppressive therapy Herpes Zoster (shingles) 1000 mg twice daily for 1 day 250 mg twice daily 500 mg every 8 hours for 7 days HIV-Infected Adult Patients ( 2.2 ) Recurrent episodes of o…

Should I take Famciclovir with food?

Famciclovir tablets may be taken with or without food.

Can I drive after taking Famciclovir?

There is no evidence that famciclovir will affect the ability of a patient to drive or to use machines.

Do I need a prescription for Famciclovir?

Usually yes. Famciclovir is a prescription medicine in most countries. Rules differ by country.

What are the side effects of Famciclovir?

The official label lists: Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions ( 5 )]. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients treated with famciclovir are headache and nausea. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients are… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Famciclovir?

The efficacy of famciclovir has not been established in pediatric patients. The pharmacokinetic profile and safety of famciclovir (experimental granules mixed with OraSweet ® or tablets) were studied in 3 open-label studies. Study 1 was a single-dose pharmacokinetic and safety study in infants 1 month to less than 1 year of age who had an active herpes simplex virus (HSV) infec… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Famciclovir when pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Available data from pharmacovigilance reports with famciclovir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the fetus associated with untreated herpes simplex virus during pregnancy (see Clinical Considerations). After oral administration… Ask your doctor or midwife first.

What medicines interact with Famciclovir?

Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. (7.2) 7.1 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 daily). No clinically significant effect on the pharmacokinetics of zidovudine, its me… Use the free interaction checker before combining medicines.

What happens if I take too much Famciclovir?

Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by hemodialysis. Get medical help right away.

How can I check that my Famciclovir is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.