Mirabegron: a safety review.

INTRODUCTION: Mirabegron is being developed as a new treatment for the management of overactive bladder (OAB). It is an orally active drug that works by activating the β(3)-adrenoceptor with a better safety profile than antimuscarinic drugs. However, long-term adverse effects are not yet completely investigated. AREAS COVERED: The following article reviews the pharmacology and efficacy of mirabegron by analyzing the tolerability findings in the data available from several Phase II placebo-controlled clinical trials conducted with an active comparator. We aim to provide familiarity with the metabolic pathway responsible for disposition of mirabegron which makes it likely to produce pharmacokinetic interactions with other drugs, as although mirabegron is generally well tolerated, its potential to cause drug interactions may limit its use in some patients. EXPERT OPINION: Mirabegron is a β(3)-adrenoceptor agonist developed to fulfill the need for a more convenient therapy and provide an improved safety/efficacy profile for OAB patients with advanced age and cognitive deficit. It has been well tolerated with significant efficacy in reducing the number of incontinence episodes and mean micturition frequency. The most commonly reported toxic effects of mirabegron are gastrointestinal adverse events and headache.