In 626 patients treated with LOPROX Shampoo (ciclopirox shampoo) twice weekly in the two pivotal clinical studies, the most frequent adverse events were increased itching in 1% of patients, and application site reactions, such as burning, erythema, and itching, also in 1% of patients. Other adverse events occurred in individual patients only.
Adverse events that led to early study medication termination in clinical trials occurred in 1.5% (26/1738) of patients treated with LOPROX Shampoo (ciclopirox shampoo) and 2.0% (12/661) of patients treated with shampoo vehicle. The most common adverse events leading to termination of study medication in either group was seborrhea. In the LOPROX Shampoo (ciclopirox shampoo) group, other adverse events included rash, pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash.