Summary of the safety profile: The safety of Mirabegron (Betmiga) was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of Mirabegron (Betmiga) in the phase 2/3 clinical program, and 622 patients received mirabegron for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with Mirabegron (Betmiga), and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity.
The most common adverse reactions reported for patients treated with Mirabegron (Betmiga) 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.
The frequency of tachycardia was 1.2% in patients receiving mirabegron 50 mg.
Tachycardia led to discontinuation in 0.1% patients receiving Mirabegron (Betmiga) 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Mirabegron (Betmiga) 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Mirabegron (Betmiga) 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies.
Tabulated list of adverse reactions: The table below reflects the adverse reactions observed with Mirabegron (Betmiga) in the three 12-week phase 3 double blind, placebo controlled studies.
The frequency of adverse reactions is defined as follows: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 5.)
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