In the combined analysis of the first-and second-line metastatic trials and post-marketing experiences other adverse reactions that were reported were cataract , eye irritation, palpitations , cardiac failure, tachycardia , dysesthesia (including hypesthesia/ paresthesia ), arterial thrombosis, memory impairment, irritability, nervousness, urticaria , increased urinary frequency, leukopenia , stomatitis cancer pain, pyrexia, vaginal discharge , appetite increase, dryness of skin and mucosa (including dry mouth ), and disturbances of taste and thirst.
Additional adverse reactions of any cause observed in the overall clinical trials program (N = 1058) in 5% or greater of patients treated with exemestane 25 mg once daily but not in the comparative study included pain at tumor sites (8%), asthenia (6%), and fever (5%). Adverse reactions of any cause reported in 2% to 5% of all patients treated with exemestane 25 mg in the overall clinical trials program but not in the comparative study included chest pain, hypoesthesia, confusion, dyspepsia , arthralgia, back pain, skeletal pain, infection, upper respiratory tract infection, pharyngitis , rhinitis , and alopecia.
Oral administration of Anastrozole to female rats (from 2 weeks before mating to pregnancy day 7) produced significant incidence of infertility and reduced numbers of viable pregnancies at 1 mg/kg/day (about 10 times the recommended human dose on a mg/m 2 basis and 9 times higher than the AUC 0-24 hr found in postmenopausal volunteers at the recommended dose). Pre-implantation loss of ova or fetus was increased at doses equal to or greater than mg/kg/day (about one-fifth the recommended human dose on a mg/m 2 basis). Recovery of fertility was observed following a 5-week non-dosing period which followed 3 weeks of dosing. It is not known whether these effects observed in female rats are indicative of impaired fertility in humans.