Depressive symptoms have occurred during postmarketing use of terbinafine. Prescribers should be alert to depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.
Transient decreases in absolute lymphocyte counts (ALC) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 Lamisil-treated patients (1.7%) and 3/137 placebo-treated patients (2.2%) had decreases in ALC to below 1000/mm3 on two or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than six weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of Lamisil, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is <1,000 cells/mm3, Lamisil should be discontinued and supportive management started.
There have been postmarketing reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with Lamisil Tablets should be discontinued.
During post-marketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Lamisil Tablets. Lamisil Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.
Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Lamisil Tablets.
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