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Up to approximately one third of the patients treated with letrozole in the metastatic settings and approximately 80% of the patients in the adjuvant setting as well as in the extended adjuvant setting experienced adverse reactions. The majority of the adverse reactions occurred during the first few weeks of treatment.
The most frequently reported adverse reactions in clinical studies were hot flushes, hypercholesterolaemia, arthralgia, fatigue, increased sweating and nausea.
Important additional adverse reactions that may occur with letrozole are skeletal events such as osteoporosis and/or bone fractures and cardiovascular events.
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