Adverse Reactions

In 11 double blind trials in264 patients using Ketoconazole Shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than1% of patients. In three open label safety trials in which 41patients shampooed 4 10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double blind, placebo controlled trial in which patients with tinea versicolor were treated with either a single application of Ketoconazole Shampoo, 2% (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug related adverse events occurred in 5 (5%),7 (7%) and 4 (4%) of patients, respectively.