Lamisil Side Effects

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).

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