Lamisil Side Effects

Generic name: terbinafine

Generic Name: Terbinafine

Please note - some side effects for Lamisil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lamisil - for the consumer

Lamisil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamisil:

Diarrhea; headache; indigestion; taste changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); red, blistered, peeling, or swollen skin; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; stomach pain; unexplained, persistent nausea; unusual tiredness; vomiting; yellowing of the skin or eyes); unusual bruising or bleeding; vision changes.

Lamisil AT Cream

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Lamisil AT Cream. Seek medical attention right away if any of these SEVERE side effects occur when using Lamisil AT Cream:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.

Lamisil AT Gel

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Lamisil AT Gel. Seek medical attention right away if any of these SEVERE side effects occur when using Lamisil AT Gel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.

Lamisil Oral Granules Granules

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamisil Oral Granules Granules:

Diarrhea; headache; indigestion; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); red, blistered, peeling, or swollen skin; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, decreased appetite, pale stools, persistent nausea, stomach pain, unusual tiredness or weakness, vomiting, yellowing of the skin or eyes); unexpected weight loss; vision changes.

Lamisil AT Spray

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Lamisil AT Spray. Seek medical attention right away if any of these SEVERE side effects occur when using Lamisil AT Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.

For the professional

Lamisil

The most frequently reported adverse events observed in the three US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

* Liver enzyme abnormalities >2x the upper limit of the normal range.

      Adverse events, based on worldwide experience with Lamisil® (terbinafine hydrochloride) Tablets use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant,, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis and precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Lamisil®. Lamisil® may cause taste disturbance (including taste loss) which usually recovers within several weeks after discontinuation of the drug. There have been reports of prolonged (greater than one year) taste disturbance. Taste disturbances associated with oral terbinafine have been reported to be severe enough to result in decreased food intake leading to significant and unwanted weight loss.

      Other adverse reactions which have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.

      Clinical adverse effects reported spontaneously since the drug was marketed include altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and Lamisil® Tablets and agranulocytosis (rare).

By body system

General side effects

In general, terbinafine side effects have been mild and transient. However, the drug has been associated with serious life threatening events such as hepatic failure, anaphylaxis, and severe neutropenia.

Gastrointestinal side effects

Taste disturbances are typically noticed 5 to 8 weeks after starting therapy and return to normal 2 to 5 weeks after stopping the medication. The taste alteration has been rarely accompanied by a discoloration of the tongue and/or a disturbance in the sense of smell.

An 80-year-old female experienced a drug reaction with eosinophilia and systemic symptoms (DRESS) secondary to severe sialadenitis coincident with terbinafine therapy. The patient was admitted with a generalized pruriginous eruption. She presented with erythematous and edematous widespread confluent plaques, with a scaly annular border. She had initiated terbinafine therapy 14 days before onset of the generalized rash, for a nonspecific squamous plaque of the trunk. DRESS induced by terbinafine was diagnosed and terbinafine intake was discontinued. Topical therapy was started with 0.5% clobetasol propionate cream applied to the whole body. The rash progressively improved and blood eosinophilia decreased.

Gastrointestinal side effects have been the most common adverse effects and have occurred in approximately 5% to 6% of patients. Symptoms have included mild to moderate gastrointestinal discomfort, diarrhea, dyspepsia, gastritis, gastric fullness, flatulence, and nausea and vomiting. Patients with hiatal hernia or gastric duodenal ulcer disease may be more likely to experience these problems. Taste disturbances have occurred in approximately 1 in 800 patients and have included hypogeusia, ageusia, and a metallic taste. At least one case of a drug reaction with eosinophilia and systemic symptoms associated with severe sialadenitis induced by terbinafine has been reported.

Dermatologic side effects

Dermatologic side effects including eczema, pruritus, rash, and urticaria have been reported in approximately 1% to 6% of patients. Reversible alopecia areata of the scalp and pustular psoriasis have been rarely reported. At least one case of acrodermatitis continua of Hallopeau has also been reported.

An 81-year-old male who had been treated with topical antifungal agents for tinea pedis started oral terbinafine 125 mg daily as the lesions did not respond to topical therapy. He was not taking any other medications and had no history of skin disease. No other skin lesions were observed at that time. Two weeks later, he developed erythematous and pustular lesions on his fingers and toes, and an erythematous macular eruption on the limbs. Oral terbinafine therapy was discontinued, but the eruptions continued to worsen. Histopathology of a punch biopsy from his toe showed intraepidermal sterile pustules containing neurophils, so-called Kogoj's spongiform pustules. He was then diagnosed with having acrodermatitis continua of Hallopeau and was treated with corticosteroids therapy.

Nervous system side effects

Nervous system side effects including mild headache (12.9%) have been reported. Dizziness and insomnia have been reported in less than 5% of patients.

Hepatic side effects

Hepatic side effects have included transient elevations in serum liver enzymes (3.3%) and the development of idiosyncratic and symptomatic hepatobiliary dysfunction. Rare cases of liver failure have also been reported with some cases leading to death or liver transplantation. A case of terbinafine-induced autoimmune hepatitis has been reported.

A 57-year-old male with chronic hepatitis B virus (HBV) infection developed terbinafine-induced acute autoimmune hepatitis coincident with terbinafine therapy. He was given 250 mg of terbinafine once daily over a 12-week period for dermatophyte toenail onychomycosis. He developed the adverse event just prior to completing the course of therapy. He was not taking any other drugs or herbal supplements, did not drink alcohol, and did not appear to suffer a flare of HBV infection. Liver function studies began to normalize 6 weeks after terbinafine was discontinued.

Hematologic side effects

Hematologic side effects which are typically reversible have been reported rarely. These have included pancytopenia, leukopenia, lymphopenia, thrombocytopenia, agranulocytosis, and neutropenia (a few cases have been severe).

Ocular side effects

Ocular changes involving the lens and retina have been reported, although the clinical significance is unknown. Dyschromatopsia, whereby the patient reported a greenish hue in her vision, and photopsia have occurred in a patient after three weeks of therapy. This problem resolved within 1 week of discontinuing the drug.

Metabolic side effects

Metabolic side effects have included hypoglycemia and hypotriglyceridemia.

Genitourinary side effects

Genitourinary side effects including transient erectile dysfunction in male patients have been reported extremely rarely.

Renal side effects

Renal side effects have been uncommonly reported. A case of renal function test impairment and rare cases of hematuria have been reported.

Hypersensitivity side effects

Hypersensitivity side effects including rare cases of anaphylaxis and hypersensitivity reactions have been reported. Erythema multiforme (including Stevens-Johnson syndrome) and toxic epidermal necrolysis have been rarely reported. Precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported during postmarketing experience. At least one case of acute generalized exanthematous pustulosis has also been reported.

A 68-year-old male experienced acute generalized exanthematous pustulosis coincident with terbinafine therapy. He presented with a symmetrical maculopapular eruption on both lower anterior legs. Within two days, the rash generalized with facial involvement. He developed the rash 20 days after initiating oral terbinafine for onychomycosis. After withdrawal of terbinafine, the exanthema abated within 10 days under topical therapy with corticosteroids.

Musculoskeletal side effects

Musculoskeletal side effects reported during postmarketing experience have included arthralgia, myalgia, and malaise.

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