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 |
| LAMISIL ®
(%)
n=465 | Placebo
(%)
n=465 | LAMISIL ®
(%)
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* | 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 |
* 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, (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 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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