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.
A 2-year carcinogenicity study in mice at doses of 50, 150, and 450 mg/kg/day exemestane (gavage), resulted in an increased incidence of hepatocellular adenomas and/or carcinomas in both genders at the high dose level. Plasma AUC (0–24hr) at the high dose were 2575 ± 386 and 5667 ± 1833 /mL in males and females (approx. 34 and 75 fold the AUC in postmenopausal patients at the recommended clinical dose). An increased incidence of renal tubular adenomas was observed in male mice at the high dose of 450 mg/kg/day. Since the doses tested in mice did not achieve an MTD, neoplastic findings in organs other than liver and kidneys remain unknown.
You should not take Arimidex if you are breastfeeding, pregnant, trying to get pregnant, or if there is any chance that you could be pregnant. Arimidex may cause damage to developing embryos. You should use an effective non-hormonal type of birth control -- such as condoms, a diaphragm along with spermicide, or a non-hormonal . – while you are taking Arimidex. Ask your doctor which type of non-hormonal birth control would be best for you, as well as how long you should use this type of birth control after you stop taking Arimidex.