Aromasin Adverse Reactions

Clinical Trials: Exemestane was generally well tolerated across all studies and in the clinical studies, conducted with exemestane 25 mg/day, adverse events were usually mild to moderate.
The discontinuation rate due to adverse events was 7.4% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy. The most commonly reported adverse reactions were hot flush (22%), arthralgia (18%) and fatigue (16%).
The discontinuation rate due to adverse events was 2.8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flush (14%) and nausea (12%).
Drug-related adverse events that occurred during clinical trials are listed as follows. Data from post-marketing surveillance are also included. The reported adverse reactions are listed as follows within each MedDRA System Organ Class (SOC) by decreasing order of medical seriousness. (See table.)

Click on icon to see table/diagram/image

In patients with advanced breast cancer, an occasional decrease in lymphocytes has been observed in approximately 20% of patients receiving exemestane, particularly in patients with pre-existing lymphopenia. However, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed.
In the early breast cancer trial, the frequency of ischemic cardiac events in the exemestane and tamoxifen treatment arms was 4.5% vs 4.2%, respectively. No significant difference was noted for any individual cardiovascular event including hypertension (9.9% vs. 8.4%), myocardial infarction (0.6% vs. 0.2%) and cardiac failure (1.1% vs. 0.7%).
In the early breast cancer trial, gastric ulcer was observed at a slightly higher frequency in the exemestane arm compared to tamoxifen (0.7% vs. <0.1%). The majority of patients on exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.