What is the overall safety experience with MYCAMINE?
The overall safety of MYCAMINE was assessed in 1980 patients and 422 volunteers in 32 clinical studies, including the esophageal candidiasis and prophylaxis studies, who received single or multiple doses of MYCAMINE, ranging from 12.5 mg to ≥150 mg/day. A total of 606 subjects (patients and volunteers) received at least 150 mg/day MYCAMINE for a minimum of 10 days. Overall, 2028 of 2402 (84.4%) subjects who received MYCAMINE experienced an adverse event. Adverse events considered to be drug-related were reported in 717 (29.9%) subjects.
