On May 9, 2001, the FDA announced a significant safety-related update to the labeling of Lamisil after it reviewed 16 cases of liver failure, that resulted in 11 deaths and two liver transplants. The agency concluded that these liver conditions might have been caused by Lamisil.

Lamisil, also known as terbinafine hydrochloride, is used to treat onychomycosis (fungal infections). It comes in a tablet form to treat fungal nail infections, and in a cream form to treat other fungal infections such as athlete's foot, jock itch, and ringworm.

Common side-effects include diarrhea, indigestion and rash. In rare cases Lamisil tablets could cause liver damage in some patients.