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warnings
WARNINGS Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine hydrochloride tablets for the treatment of onychomycosis in individuals with and without pre-existing liver disease. In the majority of liver cases reported in association with terbinafine hydrochloride use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine hydrochloride. The severity of heptic events and/or their outcome may be worse in patients with active or chronic liver disease (see PRECAUTIONS ). Treatment with terbinafine hydrochloride tablets should be discontinued if biochemical or clinical evidence of liver injury develops (see PRECAUTIONS below). There have been isolated reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine hydrochloride should be discontinued.
ADVERSE REACTIONS 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. Adverse Event Discontinuation Terbinafine Hydrochloride (%) n=465 Placebo (%) n=137 Terbinafine Hydrochloride (%) n=465 Placebo (%) n=137 Headache 12.9 9.5 0.2 0.0 Gastrointestinal Symptoms Diarrhea 5.6 2.9 0.6 0.0 Dyspepsia 4.3 2.9 0.4 0.0 Abdominal pain 2.4 1.5 0.4 0.0 Nausea 2.6 2.9 0.2 0.0 Flatulence 2.2 2.2 0.0 0.0 Dermatological Symptoms Rash 5.6 2.2 0.9 0.7 Pruritus 2.8 1.5 0.2 0.0 Urticaria 1.1 0.0 0.0 0.0 Liver Enzyme Abnormalities Liver enzyme abnormalities ≥2x the upper limit of the normal range 3.3 1.4 0.2 0.0 Taste Disturbance 2.8 0.7 0.2 0.0 Visual Disturbance 1.1 1.5 0.9 0.0 Adverse events, based on worldwide experience with terbinafine hydrochloride tablets use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, (see WARNINGS and PRECAUTIONS ), serious skin reactions (see WARNINGS ), severe neutropenia (see PRECAUTIONS ), 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 terbinafine hydrochloride. Terbinafine hydrochloride 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 terbinafine hydrochloride tablets and agranulocytosis (rare).