Prescription medicine
Famciclovir First approved as Famvir
Famciclovir (Famvir) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.214 per famciclovir 125 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the famciclovir FDA label on DailyMed (effective September 17, 2025, Macleods Pharmaceuticals Limited); the NDA 20363 record on Drugs@FDA; every famciclovir label on DailyMed.
Highlights of the record
FDA label of September 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFamciclovir, 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 recu
Forms and strengths
- 125 mg
- 250 mg
- 500 mg
Film-coated tablet.
On the market
- Earliest approval on file
- June 29, 1994 Famvir, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first August 24, 2007; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.214 per tablet Famciclovir 125 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest June 11, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 2,753 through July 30, 2026
What is famciclovir used for?
From the label: indications and usageFamciclovir, 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 […]
Conditions named in the indications of famciclovir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor and Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor.
Source: FDA drug label (Famciclovir), Macleods Pharmaceuticals Limited, effective September 17, 2025 (SPL set eeeee9c4-8566-4100-8ca4-3df936a3365d), via openFDA; the full label on DailyMed
What does the patient leaflet for famciclovir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking famciclovir tablets?You should avoid driving or operating machinery if you get dizziness, sleepiness or confusion during treatment with famciclovir tablets.
From the patient leaflet: How should I store famciclovir tablets?Store famciclovir tablets at room temperature between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep famciclovir tablets and all medicines out of reach from children.
Source: FDA drug label (Famciclovir), Aurobindo Pharma Limited, effective June 15, 2024 (SPL set fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343), via openFDA; the full label on DailyMed
Is there a generic for famciclovir (Famvir)?
The FDA approved the first generic famciclovir on August 24, 2007. 8 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists famciclovir from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2007 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for famciclovir (Famvir)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.214 per Famciclovir 125 mg tablet, down 22% from $0.273 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Famciclovir 125 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Famciclovir 125 mg tablet | Generic | $0.214 per tablet | $6.43 | -22% |
| Famciclovir 250 mg tablet | Generic | $0.442 per tablet | $13.27 | +10% |
| Famciclovir 500 mg tablet | Generic | $0.788 per tablet | $23.63 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has famciclovir been recalled?
The FDA's Enforcement Report lists 4 recalls naming famciclovir since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of famciclovir and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 11, 2025 | Class III | Macleods Pharmaceuticals Ltd | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. |
| December 22, 2017 | Class II | Hetero Labs Limited Unit V | Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high … |
| February 15, 2017 | Class II | AVKARE Inc. | Failed impurities/ degradation specifications: Product was above specification for unknown impurities. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER, Capsule, 4 mg … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the famciclovir label say about other medicines?
The famciclovir label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name famciclovir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid … |
| Cimetidine | drug interactions | Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid … |
| Digoxin | drug interactions | No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (three times daily) administration of famciclovir (500 mg) with multiple doses of digoxin. |
| Emtricitabine | drug interactions | 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. |
| Penciclovir | contraindications | CONTRAINDICATIONS Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). |
| Probenecid | drug interactions | DRUG INTERACTIONS Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity |
| Promethazine | drug interactions | Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid … |
| Raloxifene | drug interactions | Raloxifene, a potent aldehyde oxidase inhibitor in vitro, could decrease the formation of penciclovir. |
| Theophylline | drug interactions | Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid … |
| Zidovudine | drug interactions | 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. |
Source: FDA drug label (Famciclovir), Macleods Pharmaceuticals Limited, effective September 17, 2025 (SPL set eeeee9c4-8566-4100-8ca4-3df936a3365d), via openFDA; the full label on DailyMed
What do FAERS reports show for famciclovir?
The FDA Adverse Event Reporting System holds 2,753 reports that list famciclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 274 are coded as a death and 859 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as famciclovir?
2 other medicines are given the same way (oral) and in the same FDA class as famciclovir or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acyclovir | Herpes and shingles | 48 labelers | $0.0962 per tablet 400 mg tablet | No current entry |
| Valacyclovir | Herpes and shingles | 40 labelers | $0.229 per tablet 500 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does famciclovir compare with medicines for the same use?
2 side-by-side pages set famciclovir beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other herpes simplex virus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Famciclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other