Letoripe Adverse Reactions

Letrozole tablets was generally well tolerated in two controlled clinical trials.
Study discontinuations in the megestrol acetate comparison study for adverse events other than progression of tumor occurred in 5/188 (2.7%) of patients on Letrozole tablets 0.5 mg, in 4/174 (2.3%) of the patients on Letrozole tablets 2.5 mg, and in 15/190 (7.9%) of patients on megestrol acetate. There were fewer thromboembolic events at both Letrozole tablets doses than on the megestrol acetate arm (2 of 362 patients or 0.6% vs. 9 of 190 patients or 4.7%). There was also less vaginal bleeding (1 of 362 patients or 0.3% vs. 6 of 190 patients or 3.2%) on letrozole than on megestrol acetate. In the aminoglutethimide comparison study discontinuations for reasons other than progression occurred in 6/193 (3.1%) of patients on 0.5 mg Letrozole tablets, 7/185 (3.8%) of patients on 2.5 mg Letrozole tablets, and 7/178 (3.9%) of patients on aminoglutethimide.
Other less frequent (<5%) adverse experiences considered consequential and reported in at least 3 patients treated with Letrozole tablets included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating and vertigo.