Ovupic Adverse Reactions

Summary of the safety profile: The frequencies of adverse reactions for Letrozole are mainly based on data collected from clinical trials.
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, hypercholesterolemia, 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 (including cerebrovascular and thromboembolic events). The frequency category for these adverse reactions is described in Table 1.
Tabulated list of adverse reactions: The frequencies of adverse reactions for Letrozole are mainly based on data collected from clinical trials.
The following adverse drug reactions, listed in Table 1, were reported from clinical studies and from post-marketing experience with Letrozole tablets.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 1.)

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Some adverse reactions have been reported with notably different frequencies in the adjuvant treatment setting. The following tables provide information on significant differences in Letrozole versus tamoxifen monotherapy and in the Letrozole-tamoxifen sequential treatment therapy: See Tables 2 and 3.

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