In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo, an increase in normal hair loss and irritation occurred in <1% of patients. In 3 open-label safety trials in which 41 patients shampooed 4-10 times weekly for 6 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.