Prescription and over-the-counter medicine
Terbinafine Brand names: Lamisil
Terbinafine (Lamisil) is a prescription and over-the-counter medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.143 per terbinafine HCl 250 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the terbinafine FDA label on DailyMed (effective October 17, 2025, PD-Rx Pharmaceuticals, Inc.); the NDA 20192 record on Drugs@FDA; every terbinafine label on DailyMed.
Highlights of the record
FDA label of October 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Forms and strengths
- 250 mg
- 1 g/100g
Tablet; cream; spray.
On the market
- Earliest approval on file
- December 30, 1992 Lamisil, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 2, 2007; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 42 of which 39 under generic applications, 3 under brand applications, repackagers included; 3 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.143 per tablet Terbinafine HCl 250 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,847 through July 30, 2026
What is terbinafine used for?
From the label: indications and usageINDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Conditions named in the indications of terbinafine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Allylamine Antifungal.
Source: FDA drug label (Terbinafine Hydrochloride), PD-Rx Pharmaceuticals, Inc., effective October 17, 2025 (SPL set 2df111dc-ecac-4161-9e22-38436eb37c1f), via openFDA; the full label on DailyMed
What does the patient leaflet for terbinafine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Terbinafine tablets?Terbinafine tablets may cause serious side effects, including: Liver problems that can lead to the need for a liver transplant or death. This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of liver problems: nausea poor appetite tiredness vomiting upper right stomach-area (abdomen) pain yellowing of your skin or eyes (jaundice) dark (tea-colored) urine pale or light colored stools Your doctor should do a blood test to check you for liver problems before you start treatment with Terbinafine tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Terbinafine tablets if you develop liver problems.
From the patient leaflet: What should I avoid while taking Terbinafine tablets?Avoid sunlight. Terbinafine tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.
From the patient leaflet: How should I store Terbinafine tablets?Store Terbinafine Tablets at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Keep Terbinafine tablets in a tightly closed container and keep out of the light. Keep Terbinafine tablets and all medicines out of the reach of children.
Source: FDA drug label (Terbinafine Hydrochloride), PD-Rx Pharmaceuticals, Inc., effective October 17, 2025 (SPL set 2df111dc-ecac-4161-9e22-38436eb37c1f), via openFDA; the full label on DailyMed
Is there a generic for terbinafine (Lamisil)?
The FDA approved the first generic terbinafine on July 2, 2007. 13 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists terbinafine from 39 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1992 earliest approval on file
- 2007 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for terbinafine (Lamisil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.143 per Terbinafine HCl 250 mg tablet, down 5% from $0.150 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.
- Terbinafine HCl 250 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Athlete's foot 1% cream | Generic | $0.231 per gram | n/a | +1% |
| Terbinafine 1% cream | Generic | $0.353 per gram | n/a | +1% |
| Terbinafine HCl 250 mg tablet | Generic | $0.143 per tablet | $4.28 | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the terbinafine label say about other medicines?
The terbinafine label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name terbinafine. 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 |
|---|---|---|
| Amiodarone | drug interactions | Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also lead to a substantial increase in the systemic exposure (C max and AUC) of terbinafine when concomitantly administered. |
| Caffeine | drug interactions | Drug interactions have also been noted with cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. |
| Cimetidine | drug interactions | Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. |
| Cyclosporine | drug interactions | In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin. |
| Desipramine | drug interactions | DRUG INTERACTIONS Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on metabolism of desipramine. |
| Dextromethorphan | drug interactions | In studies in healthy subjects characterized as extensive metabolizers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increases the dextromethorphan/ dextrorphan metabolite ratio in urine by 16- to 97-fold on average. |
| Digoxin | drug interactions | In vivo drug-drug interaction studies conducted in healthy volunteer subjects showed that terbinafine does not affect the clearance of antipyrine or digoxin. |
| Flecainide | drug interactions | Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. … |
| Fluconazole | drug interactions | The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant. |
| Fluvastatin | drug interactions | In vitro studies with human liver microsomes showed that terbinafine does not inhibit the metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin, cyclosporine, cisapride and fluvastatin. |
| Ketoconazole | drug interactions | Based on this finding, it is likely that other inhibitors of both CYP2C9 and CYP3A4 (e.g., ketoconazole, amiodarone) may also lead to a substantial increase in the systemic exposure (C max and AUC) of terbinafine when concomitantly administered. |
| Propafenone | drug interactions | Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. … |
| Rifampin | drug interactions | Terbinafine clearance is increased 100% by rifampin, a CYP450 enzyme inducer, and decreased 33% by cimetidine, a CYP450 enzyme inhibitor. |
| Theophylline | drug interactions | The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant. |
Every other medicine the terbinafine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Trimethoprim | drug interactions | The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant. |
| Warfarin | drug interactions | There have been spontaneous reports of increase or decrease in prothrombin times in patients concomitantly taking oral terbinafine and warfarin, however, a causal relationship between Terbinafine … |
| Zidovudine | drug interactions | The influence of terbinafine on the pharmacokinetics of fluconazole, cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline was not considered to be clinically significant. |
Other labels that name terbinafine
Source: FDA drug label (Terbinafine Hydrochloride), PD-Rx Pharmaceuticals, Inc., effective October 17, 2025 (SPL set 2df111dc-ecac-4161-9e22-38436eb37c1f), via openFDA; the full label on DailyMed
What do FAERS reports show for terbinafine?
The FDA Adverse Event Reporting System holds 8,847 reports that list terbinafine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 532 are coded as a death and 2,352 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 terbinafine?
8 other medicines are given the same way (oral) and in the same FDA class as terbinafine or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 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 |
|---|---|---|---|---|
| Fluconazole | Fungal infections | 38 labelers | $0.380 per tablet 200 mg tablet | No current entry |
| Voriconazole | Fungal infections | 21 labelers | $1.88 per tablet 200 mg tablet | A presentation being discontinued |
| Nystatin | Fungal infections | 21 labelers | $0.0569 per mL 100,000 unit/mL suspension | No current entry |
| Posaconazole | Fungal infections | 21 labelers | $2.03 per tablet 100 mg tablet | A presentation being discontinued |
| Griseofulvin | Fungal infections | 10 labelers | $3.74 per tablet 250 mg tablet | No current entry |
| Flucytosine | Fungal infections | 9 labelers | n/a | No current entry |
| Itraconazole | Fungal infections | 11 labelers | $0.910 per capsule 100 mg capsule | A presentation being discontinued |
| Clotrimazole | Fungal infections | 3 labelers | $0.292 per troche 10 mg troche | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does terbinafine compare with medicines for the same use?
10 side-by-side pages set terbinafine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other allylamine antifungals
- the pharmacologic class, with prices and generics
- Terbinafine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other