Letoripe Adverse Reactions

Letrozole tablet was generally well tolerated in two controlled clinical trials. Study discontinuations in the megestrol acetate comparisons study for adverse events other than progression of tumor occurred in 5/188 (2.7%) of patients on Letrozole tablet 0.5 mg, in 4/174 (2.3%) of the patients on Letrozole tablet 2.5 mg, and in 15/190 (7.9%) of patients on megestrol acetate. There were fewer thromboembolic events at both Letrozole tablet 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 loss in 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 tablet, and 7/185 (3.8%) of patients on 2.5 mg Letrozole tablet, 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 tablet included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating, and vertigo.
Undesirable Effects: Letrozole tablet was generally well tolerated across in first-line and second-line metastatic breast cancer, adjuvant treatment, as well as extended adjuvant treatment in women who have received prior adjuvant tamoxifen treatment. Generally, the observed adverse reactions are mild or moderate in nature. Hot flashes, arthralgia, night sweats, weight increase, nausea, fatigue, edema, headache, vomiting, dizziness, constipation, vaginal irritation, osteoporosis, angina.
Undesirable effects with Letrozole tablet included hypercalcemia, fracture, depression, anxiety, pleural effusion, alopecia, increased sweating, and vertigo.