Generic Terbinafine

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Terbinafine (terbinafine hydrochloride) is a synthetic allylamine antifungal agent taken orally for the treatment of dermatophyte infections of the skin, hair, and nails. It works by inhibiting squalene epoxidase, a key enzyme in the biosynthesis of ergosterol—an essential component of the fungal cell membrane. This inhibition disrupts membrane integrity, causing intracellular contents to leak out and leading to death of the fungus. Because terbinafine accumulates in keratinized tissues such as nails, hair, and skin, it provides fungicidal concentrations that persist for weeks after the course of treatment is completed.

Usual adult dose: The standard dose is one 250 mg tablet taken once daily with or without food. For fingernail onychomycosis (fungal nail infection), treatment is continued for 6 weeks. For toenail onychomycosis, treatment lasts for 12 weeks. The optimal clinical effect is seen some months after mycological cure and cessation of treatment, as it takes time for the healthy nail to grow out. For tinea capitis (scalp ringworm), the typical duration is 4 weeks. For tinea corporis (ringworm of the body) or tinea cruris (jock itch), treatment of 2 to 4 weeks is usually sufficient.

Dosage form: Oral tablets containing 250 mg of terbinafine (as terbinafine hydrochloride).

Onset of action: Terbinafine is well absorbed after oral administration (greater than 70%), with peak plasma concentrations reached within 2 hours of a single 250 mg dose. Clinical improvement in skin infections may be seen within days to a week; however, nail infections require several months for visible improvement because the drug must be incorporated into the newly growing nail plate.

Duration of action: The elimination half‑life is approximately 36 hours at steady‑state, with a terminal half‑life of 200–400 hours reflecting slow release from tissues such as skin and adipose tissue. Fungicidal concentrations persist in the nail plate for many weeks after the last dose.

Alcohol recommendation: Alcohol consumption should be avoided during treatment with oral Terbinafine. Alcohol can increase the risk of liver toxicity, and terbinafine is known to be associated with rare but serious hepatotoxicity. The combination may place additional strain on the liver. Patients with a history of heavy alcohol use should inform their prescriber before starting therapy.

Most common side effects: Headache (approximately 13%), gastrointestinal disturbances (diarrhoea, dyspepsia, nausea, abdominal pain, and flatulence), rash, pruritus (itching), and taste disturbance (including taste loss, which can be severe enough to cause decreased food intake, weight loss, anxiety, and depressive symptoms). Elevations in liver enzymes occur in approximately 3% of patients. Most side effects are mild to moderate and transient.

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General Information about Terbinafine

• INN (International Nonproprietary Name): Terbinafine (as terbinafine hydrochloride).
• Brand names available in Canada: Lamisil® (Novartis Pharmaceuticals Canada Inc.; the brand‑name product is now cancelled post‑market, as of March 2025). Widely available generic versions include APO‑Terbinafine (Apotex Inc.), TEVA‑Terbinafine / ACT Terbinafine (Teva Canada Limited), Sandoz Terbinafine (Sandoz Canada Inc.), PMS‑Terbinafine (Pharmascience Inc.), AURO‑Terbinafine (Auro Pharma Inc.), JAMP‑Terbinafine (JAMP Pharma Corporation), and terbinafine tablets from several other generic manufacturers including Sun Pharma Canada Inc., Sanis Health Inc., and Marcan Pharmaceuticals Inc.
• ATC code: D01BA02 (allylamine antifungals for systemic use).
• Dosage forms and strengths: Oral tablets: 250 mg (as terbinafine hydrochloride). Tablets are typically supplied in packs of 30 or 100. A 125 mg tablet strength is also available in some markets for paediatric use.
• Manufacturers in Canada: Novartis Pharmaceuticals Canada Inc. (historical, Lamisil), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., Auro Pharma Inc., JAMP Pharma Corporation, Sun Pharma Canada Inc., Sanis Health Inc., Marcan Pharmaceuticals Inc., and other generic pharmaceutical companies.
• Registration status in Canada: Approved by Health Canada. Lamisil® 250 mg tablet received its Notice of Compliance (NOC) on May 4, 1993, and was first marketed May 5, 1993. The brand is now cancelled post‑market (effective March 2025), but multiple generic formulations remain widely available by prescription. DINs include 02031116 (Lamisil, cancelled), 02254727 (ACT Terbinafine 250 mg), and various other DINs for generic products.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Terbinafine hydrochloride is a synthetic allylamine antifungal agent structurally and pharmacologically related to naftifine. Its antifungal activity is mediated through the potent and selective inhibition of squalene epoxidase, a key enzyme in the biosynthesis of ergosterol—the principal sterol in fungal cell membranes. By blocking this enzyme, terbinafine causes squalene to accumulate within the fungal cell while ergosterol becomes depleted. The buildup of squalene, which is toxic to fungi at high concentrations, together with the absence of ergosterol, disrupts the integrity and function of the fungal cell membrane, leading to leakage of intracellular contents and fungal cell death. Terbinafine is fungicidal (rather than merely fungistatic) against dermatophytes, moulds, and certain dimorphic fungi at clinically achievable concentrations. Importantly, terbinafine inhibits fungal squalene epoxidase at concentrations approximately 4,000‑fold lower than those required to inhibit the mammalian enzyme, conferring a high degree of selectivity for the fungal target.

Following oral administration, terbinafine is well absorbed (greater than 70% absorbed), and the absolute bioavailability as a result of first‑pass metabolism is approximately 40%. Peak plasma concentrations of approximately 1 μg/mL are reached within 2 hours after a single 250 mg dose; the area under the curve (AUC) is approximately 4.56 μg·h/mL. An increase in the AUC of less than 20% is observed when terbinafine is administered with food, which is not clinically significant enough to require dose adjustments. Terbinafine is highly lipophilic and keratophilic; it distributes extensively into the sebum, stratum corneum, hair follicles, and nail plate. It is more than 99% bound to plasma proteins with no specific binding sites. At steady‑state, in comparison to a single dose, the peak concentration of terbinafine is 25% higher and the plasma AUC increases by a factor of 2.5; this increase in plasma AUC is consistent with an effective half‑life of approximately 36 hours. A terminal half‑life of 200–400 hours may represent the slow elimination of terbinafine from tissues such as skin and adipose. Prior to excretion, terbinafine is extensively metabolized by at least seven cytochrome P450 (CYP) isoenzymes, with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19. No metabolites with antifungal activity similar to terbinafine have been identified. Approximately 70% of the administered dose is eliminated in the urine. In patients with renal impairment (creatinine clearance ≤ 50 mL/min) or hepatic cirrhosis, the clearance of terbinafine is decreased by approximately 50% compared with normal volunteers.

Terbinafine is a potent in vitro and in vivo inhibitor of CYP2D6, an isoenzyme responsible for the metabolism of a wide variety of drugs. Thus, terbinafine may convert CYP2D6 extensive metabolizers to poor metabolizer status, an effect that may be clinically important for drugs with a narrow therapeutic window that are predominantly metabolized by CYP2D6.

Indications

• Onychomycosis (tinea unguium): Terbinafine tablets are indicated for the treatment of dermatophyte infections of the fingernail or toenail (onychomycosis) caused by susceptible strains of Trichophyton rubrum and Trichophyton mentagrophytes. Fingernail infections are treated for 6 weeks; toenail infections for 12 weeks. Clinical cure is evaluated several months after cessation of therapy, once the healthy nail has fully grown out.
• Tinea capitis (scalp ringworm): Treatment of tinea capitis caused by Trichophyton and Microsporum species. Terbinafine is dosed for 4 to 6 weeks, depending on the causative organism. A network meta‑analysis has shown terbinafine to be the most efficacious agent for Trichophyton species tinea capitis, with superior mycological and complete cure rates compared with griseofulvin, fluconazole, and itraconazole. For Microsporum canis infections, griseofulvin may be more effective.
• Tinea corporis and tinea cruris (off‑label): Oral terbinafine may be used for extensive, refractory, or immunocompromised patients with dermatophyte infections of the body and groin when topical therapy has failed. The usual treatment duration is 2 to 4 weeks.
• Tinea pedis (athlete’s foot) (off‑label): For severe, extensive, or refractory plantar‑type tinea pedis, oral terbinafine 250 mg daily for 2 to 6 weeks is an effective option.
• Lymphocutaneous and cutaneous sporotrichosis (off‑label): Terbinafine 500 mg daily (in divided doses) for 2 to 6 weeks, followed by 2 to 4 weeks of additional therapy after resolution of all lesions.
• Terbinafine is not approved by Health Canada for use in children for onychomycosis; paediatric dosing for tinea capitis is weight‑based and should be managed by a specialist.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: Terbinafine should be used during pregnancy only if the potential benefit clearly outweighs the potential risk. There are no adequate and well‑controlled studies in pregnant women. Animal reproduction studies have not revealed evidence of impaired fertility or harm to the foetus. However, because systemic exposure from oral therapy is substantial, terbinafine is generally not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment.
• Breastfeeding: Terbinafine is excreted in human breast milk. After oral administration, the milk‑to‑plasma ratio is approximately 7:1. Because of the potential for serious adverse reactions in a nursing infant, including hepatotoxicity, a decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother. Breastfeeding is not recommended during oral terbinafine therapy. The infant should be monitored for signs of liver toxicity (including jaundice), especially if exclusively breastfed.
• Paediatrics (< 18 years): Terbinafine tablets are not recommended for the treatment of onychomycosis in children. Safety and efficacy for onychomycosis in paediatric patients have not been established. For tinea capitis, terbinafine may be prescribed off‑label for children aged 4 years and older, with weight‑based dosing (125 mg/day for children weighing less than 25 kg; 187.5 mg/day for those 25–35 kg; 250 mg/day for those weighing more than 35 kg, typically for 6 weeks). Use should be under specialist supervision.
• Elderly: No dose adjustment is required based on age alone. However, elderly patients are more likely to have age‑related decline in renal or hepatic function and may be at greater risk of drug accumulation and hepatotoxicity. Liver function should be assessed before and during treatment. Particular caution is advised in patients with pre‑existing liver disease or those taking multiple medications.
• Hepatic impairment: Terbinafine is contraindicated in patients with chronic or active liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before starting terbinafine tablets. Hepatotoxicity may occur in patients with and without pre‑existing liver disease. Cases of hepatic failure, some leading to death or liver transplant, have been reported worldwide. Most cases occurred within the first 6 weeks of therapy. Terbinafine should be discontinued immediately if liver injury is suspected, and patients should be warned to report immediately any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools.
• Renal impairment: The use of terbinafine has not been adequately studied in patients with renal impairment (creatinine clearance ≤ 50 mL/min or 0.83 mL/s) and is therefore not recommended in this population. In patients with mild to moderate renal impairment, no dose adjustment has been specifically established.
• Haematological effects: Very rare cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported. A complete blood count (CBC) should be considered at baseline in patients with a history of heavy alcohol consumption, pre‑existing hepatitis, or history of haematological abnormalities.
• Dermatological reactions: Serious skin reactions, including Stevens‑Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported rarely. Terbinafine should be discontinued if a progressive skin rash occurs.
• Taste disturbance: Taste disturbance, including taste loss, has been reported in clinical trials and post‑marketing experience with terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of therapy, but may be prolonged (lasting more than one year) or may be permanent. Patients should be advised to report any change in taste or smell.
• Mood disturbance: Depressive symptoms, anxiety, and mood changes have been reported in association with terbinafine use, sometimes in the context of severe taste disturbance. Patients should be monitored for changes in mood or behaviour.
• Photosensitivity: Terbinafine may increase sensitivity to sunlight. Patients should avoid prolonged sun exposure and use adequate sun protection during treatment.
• Systemic lupus erythematosus: Terbinafine may exacerbate or activate pre‑existing systemic lupus erythematosus. Use with caution in patients with a known history of SLE.
• Allergy: Do not take Terbinafine if you have a known hypersensitivity to terbinafine hydrochloride or any excipient in the formulation.

Driving and alcohol

Terbinafine is not generally expected to impair the ability to drive or operate machinery. However, some patients may experience dizziness, fatigue, or visual disturbances, and should ensure they are not adversely affected before driving or engaging in hazardous activities. Alcohol should be avoided during treatment with oral terbinafine. Alcohol consumption increases the risk of hepatotoxicity, and the combination of alcohol and terbinafine places additional strain on the liver. In patients with a history of heavy alcohol consumption, terbinafine should be used only with extreme caution and under close monitoring, including baseline and periodic liver function tests.

Dosage Instructions

• Fingernail onychomycosis (adults): One 250 mg tablet taken orally once daily for 6 weeks. Optimal clinical effect is seen some months after mycological cure and cessation of treatment, as the healthy nail grows out and replaces the infected nail.
• Toenail onychomycosis (adults): One 250 mg tablet taken orally once daily for 12 weeks. The longer treatment duration reflects the slower growth rate of toenails. Re‑evaluation of the patient 3–6 months after treatment initiation is recommended, and a full clinical response may not be apparent until 9–12 months after therapy is completed.
• Tinea capitis (adults and children ≥ 4 years, > 35 kg): One 250 mg tablet once daily for 4 to 6 weeks, depending on the causative organism. For Trichophyton species, a 4‑week course may be sufficient; for Microsporum species, 6 weeks or longer may be required.
• Paediatric dosing for tinea capitis (off‑label): Children weighing less than 25 kg: 125 mg once daily. Children 25–35 kg: 187.5 mg once daily. Children weighing more than 35 kg: 250 mg once daily. All regimens are typically given for 6 weeks. Terbinafine 125 mg tablets or compounded formulations may be used to achieve these doses.
• Tinea corporis, tinea cruris, tinea pedis (off‑label, adults): One 250 mg tablet once daily for 2 to 4 weeks (tinea pedis may require up to 6 weeks).
• Administration: Terbinafine tablets should be swallowed whole with a glass of water. They may be taken with or without food; food has a minimal effect on absorption and is not clinically significant. Taking the tablet at the same time each day helps maintain consistent blood levels. Do not crush, chew, or split the tablet.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next scheduled dose, skip the missed dose and continue with the regular daily schedule. Do not double the dose to make up for a missed one.
• Duration of therapy: Complete the full prescribed course, even if symptoms improve earlier. Stopping treatment prematurely may lead to relapse of the infection. The optimal clinical effect for nail infections is assessed months after therapy completion, when the healthy nail has grown out.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Headache (approximately 13%).
• Common side effects (1–10%): Diarrhoea (6%), rash (6%), dyspepsia (4%), nausea (3%), elevated liver function tests (3%), taste disturbance including taste loss (3%), pruritus (3%), abdominal pain (2%), flatulence (2%), and fatigue. Visual disturbances (1%) have also been reported.
• Uncommon but clinically important side effects: Taste disturbance can be severe and may result in decreased food intake, significant weight loss, anxiety, and depressive symptoms. Taste disturbance may persist for weeks to months after discontinuation and, in rare cases, may be permanent. Arthralgia (joint pain) and myalgia (muscle pain) may occur. Photosensitivity reactions have been reported.
• Rare but serious side effects: Hepatotoxicity, including hepatic failure (some cases leading to death or liver transplant), has been reported in patients with and without pre‑existing liver disease. Serious skin reactions including Stevens‑Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and DRESS syndrome. Blood dyscrasias including neutropenia, agranulocytosis, thrombocytopenia, and pancytopenia (very rare). Anaphylaxis, angioedema, and serum sickness‑like reactions have been reported in post‑marketing surveillance. Pancreatitis has been reported rarely. Exacerbation or activation of systemic lupus erythematosus (SLE) has been reported. Rhabdomyolysis has been reported in isolated cases.
• Contraindications: Hypersensitivity to terbinafine hydrochloride or any excipient in the formulation. Chronic or active liver disease. Severe renal impairment (creatinine clearance ≤ 50 mL/min) without adequate study data. Pregnancy (relative contraindication). Breastfeeding (relative contraindication). Concomitant use with strong CYP2D6 substrates that have a narrow therapeutic index should be undertaken only with caution and dose monitoring.

Drug Interactions

• Drugs metabolized by CYP2D6 — monitor closely: Terbinafine is a potent inhibitor of CYP2D6 and may convert extensive metabolizers to poor metabolizer status. Co‑administration with drugs predominantly metabolized by CYP2D6—particularly those with a narrow therapeutic index—may result in significant increases in plasma concentrations and an increased risk of adverse effects. Affected drug classes include: tricyclic antidepressants (e.g., amitriptyline, nortriptyline, desipramine, imipramine, clomipramine), selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine), beta‑blockers (e.g., metoprolol, propranolol, timolol), monoamine oxidase (MAO) inhibitors, antiarrhythmics (e.g., flecainide, propafenone, encainide), antipsychotics (e.g., haloperidol, risperidone, aripiprazole), and atomoxetine. Dose reduction of the CYP2D6 substrate should be considered.
• Tamoxifen — avoid concomitant use: Terbinafine inhibits CYP2D6, the enzyme required to convert tamoxifen to its active metabolite endoxifen. Chronic co‑administration may reduce the therapeutic efficacy of tamoxifen in breast cancer treatment. An alternative antifungal agent with minimal CYP2D6 inhibition should be considered.
• CYP2C9 and CYP3A4 substrates — potential interaction: Terbinafine is metabolized by and may influence the activity of CYP2C9 and CYP3A4. Co‑administration with warfarin, phenytoin, oral hypoglycaemics, or other CYP2C9 substrates may require monitoring and dose adjustment. Rifampin (a CYP inducer) may increase the clearance of terbinafine, potentially reducing its therapeutic efficacy.
• Cimetidine — increased terbinafine exposure: Cimetidine may decrease the clearance of terbinafine by approximately 30%, leading to increased plasma levels. This interaction is generally not considered clinically significant, but dose adjustment of terbinafine may be considered.
• Cyclosporine — modest reduction in cyclosporine levels: Terbinafine may increase the clearance of cyclosporine by approximately 15%. Monitoring of cyclosporine blood levels is recommended.
• Alcohol — increased hepatotoxicity risk: Alcohol should be avoided during treatment, as it increases the risk of hepatotoxicity. Patients with a history of heavy alcohol use are at greater risk of liver injury from terbinafine and should have baseline and periodic liver function testing.
• Anticoagulants — monitor INR: Terbinafine has been associated with rare cases of altered prothrombin time when co‑administered with warfarin. Monitor INR carefully and adjust warfarin dose as needed.

Practical Advice

• Administration: Take one tablet once daily at approximately the same time each day. Swallow the tablet whole with a glass of water; do not crush, chew, or split. The tablet may be taken with or without food. Taking it with food may reduce mild gastrointestinal upset.
• Monitoring: Serum transaminase (ALT and AST) levels should be obtained in all patients before starting terbinafine tablets. Liver function should be reassessed periodically during treatment, especially in patients with risk factors for hepatotoxicity. In patients with a history of heavy alcohol consumption, pre‑existing hepatitis, or history of haematological abnormalities, a complete blood count (CBC) should be obtained at baseline. Patients should be educated about the signs and symptoms of liver injury (persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, pale stools) and instructed to report these immediately to their physician. Renal function should be assessed before treatment in patients with suspected renal impairment.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed. Keep out of the reach and sight of children.
• Lifestyle: To maximize the effectiveness of therapy, practise good foot and hand hygiene. For toenail infections: keep nails trimmed short, wear clean cotton or wool socks, and use well‑ventilated footwear. Avoid walking barefoot in communal areas. Do not share towels, nail clippers, or footwear with others. If tinea pedis is present, treat the skin infection concurrently to prevent reinfection of the nail. Complete the full prescribed course of therapy even if the nail begins to look better, as stopping early increases the risk of relapse.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next dose, skip the missed dose and return to the regular daily schedule. Do not take two tablets at once.
• When to seek medical review: Contact your doctor immediately if you develop any signs of liver injury (persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the right upper abdomen, yellowing of the skin or whites of the eyes, dark urine, or pale stools). Report any progressive skin rash, severe taste disturbance that interferes with eating, unexplained bruising or bleeding, signs of infection (fever, sore throat, mouth ulcers), or changes in mood or behaviour. Seek emergency medical attention for signs of a serious allergic reaction (such as difficulty breathing, swelling of the face, lips, tongue, or throat, or a severe widespread rash). If you become pregnant during treatment, inform your doctor.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Itraconazole (Sporanox®): An oral triazole antifungal available by prescription in Canada. It is used for onychomycosis and other systemic fungal infections. Itraconazole is typically given as a pulse‑dosing regimen (e.g., 200 mg twice daily for one week per month). It is an alternative when terbinafine is contraindicated or not tolerated. Head‑to‑head trials have shown that continuous terbinafine is more effective than intermittent itraconazole for toenail onychomycosis, though itraconazole has a different adverse effect profile and drug interaction profile.
• Fluconazole (Diflucan®): An oral triazole antifungal used for dermatophyte infections. It is less effective than terbinafine for onychomycosis but may be an option for patients who cannot take terbinafine. Mycological cure rates for toenail onychomycosis are lower (47–62%).
• Griseofulvin (Grisovin®): An older oral antifungal agent that has been largely superseded by terbinafine and the azoles. Griseofulvin requires longer treatment durations (12–18 months for toenail onychomycosis) and is generally less effective. It remains an option for tinea capitis caused by Microsporum canis, where it may be superior to terbinafine.
• Topical antifungals (onychomycosis): Efinaconazole (Jublia®) and ciclopirox (Penlac®) are topical nail lacquers available by prescription in Canada. They are applied directly to the nail surface daily, but have lower complete cure rates than oral terbinafine (approximately 17% for efinaconazole and 8% for ciclopirox at one year, compared with approximately 60% for oral terbinafine). Topical therapy is generally reserved for mild to moderate cases with limited nail involvement, particularly in patients who cannot or will not take an oral antifungal. Over‑the‑counter topical creams (clotrimazole, terbinafine cream, miconazole) are not effective for nail infections.
• Topical antifungals (skin infections): For tinea corporis, tinea cruris, and mild tinea pedis, topical terbinafine cream (Lamisil® cream), clotrimazole, miconazole, and ketoconazole cream are available over the counter and are generally effective first‑line therapies. Oral terbinafine is reserved for extensive, refractory, or severe cases.
• Non‑pharmacological management: Good foot hygiene, keeping the skin clean and dry, wearing breathable natural‑fibre clothing, changing socks daily, and avoiding shared personal items (towels, nail clippers) are essential preventive and adjunctive measures. Nail debridement (trimming and filing of thickened nails) may improve the appearance of nails and facilitate the action of topical agents when used as adjunctive therapy.

Clinical Efficacy

The efficacy of oral terbinafine 250 mg daily for the treatment of dermatophyte infections has been established in numerous randomized, double‑blind, placebo‑controlled and active‑comparator clinical trials. For toenail onychomycosis, a pooled analysis of two pivotal clinical trials found that continuous terbinafine 250 mg daily for 12 weeks was significantly more effective than placebo, with mycological cure rates of approximately 70–80% and complete clinical cure rates of approximately 60% at 48‑week follow‑up. The efficacy of terbinafine did not appear to improve with an additional 3 months of treatment. In a head‑to‑head, double‑blind, randomized trial comparing terbinafine 250 mg daily with itraconazole 200 mg daily for dermatophyte toe onychomycosis over 12 weeks, terbinafine demonstrated a higher rate of mycological cure and clinical resolution. Continuous terbinafine has been shown to be significantly more effective than intermittent itraconazole in the treatment of toenail onychomycosis. A 2025 randomized double‑blind trial demonstrated that pulse‑dose terbinafine is as effective as continuous daily dosing, offering a potential strategy to reduce drug exposure and cost while maintaining comparable efficacy.

For tinea capitis, a network meta‑analysis of randomized controlled trials demonstrated that terbinafine was the most efficacious agent for Trichophyton species infections, with mycological cure rates of approximately 81% after 4–6 weeks of treatment. For Microsporum species, griseofulvin may have a slight advantage. Terbinafine has been shown to be at least as effective as griseofulvin for tinea capitis overall, with a shorter treatment duration (4–6 weeks versus 8–12 weeks) and a more favourable tolerability profile.

For cutaneous dermatophyte infections (tinea corporis, tinea cruris, tinea pedis), mycological cure rates of 80–90% have been reported after 2–6 weeks of oral terbinafine 250 mg/day, with clinical improvement often seen within the first week of therapy. Terbinafine is recommended as a first‑line oral antifungal agent for dermatophytosis in Canadian clinical practice, particularly for nail infections where it offers superior mycological cure rates compared with azole antifungals. Its fungicidal mechanism of action, high affinity for keratinized tissues, and relatively favourable drug interaction profile (compared with azoles) make it the preferred oral agent for dermatophyte nail infections in immunocompetent patients without hepatic or renal impairment. However, the risk of hepatotoxicity necessitates baseline liver function testing and clinical monitoring throughout the course of therapy.

Important:

Terbinafine is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It can cause serious, life‑threatening hepatotoxicity, including hepatic failure requiring liver transplantation or resulting in death, even in patients without pre‑existing liver disease. Baseline liver function tests (ALT and AST) must be obtained in all patients before starting treatment, and patients must be monitored for signs and symptoms of liver injury throughout therapy. Terbinafine is contraindicated in patients with chronic or active liver disease. If you develop persistent nausea, loss of appetite, unusual tiredness, vomiting, right upper abdominal pain, yellowing of the skin or eyes, dark urine, or pale stools, discontinue the medication immediately and contact your doctor. Serious skin reactions (Stevens‑Johnson syndrome, toxic epidermal necrolysis, DRESS) have been reported; discontinue terbinafine if a progressive rash develops. Taste disturbance, including permanent loss of taste, has been reported and can lead to significant weight loss, anxiety, and depression. Terbinafine is an inhibitor of CYP2D6 and may increase the blood levels of many other medications—inform your doctor of all drugs you are taking, including antidepressants, beta‑blockers, and antipsychotics. Alcohol must be avoided during treatment. Do not use terbinafine if you are pregnant, may become pregnant, or are breastfeeding without consulting your physician. Complete the full course of therapy, even if your nail or skin appears better. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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