Mirabegron is the major circulating component following a single dose of The Cmax and AUC of mirabegron following multiple oral doses in elderly volunteers (≥ 65 years) were similar to those in younger volunteers (18 to 45 years) [see The pharmacokinetics of mirabegron in pediatric patients have not been evaluated [see The Cmax and AUC of mirabegron were approximately 40% to 50% higher in females than in males. For the 10mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction and one intestinal obstruction).In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo) for Myrbetriq 25mg and 50mg versus placebo, respectively, were hypertension (11.3%, 7.5% vs. 7.6%), nasopharyngitis (3.5%, 3.9% vs. 2.5%), urinary tract infection (4.2%, 2.9% vs. 1.8%), and headache (2.1%, 3.2% vs. 3.0%).In clinical trials, the most commonly reported adverse reactions (> 2% and > placebo and > comparator) for Myrbetriq in combination with solifenacin succinate 25mg + 5mg and 50mg + 5mg versus Myrbetriq 25mg, Myrbetriq 50mg, solifenacin succinate 5mg and placebo, respectively, were dry mouth (9.3%, 7.2% vs. 3.8%, 3.6%, 6.5%, 2.2%), urinary tract infection (7.0%, 4.0% vs. 4.0%, 4.2%, 3.6%, 5.3%), constipation (4.2%, 3.9% vs. 1.2%, 2.8%, 2.4%, 1.2%), and tachycardia (2.2%, 0.9% vs. 1.6%, 1.6%, 0.7%, 0.8%).In postmarketing experience with mirabegron, the following events have also occurred: atrial fibrillation, nausea, constipation, diarrhea, and dizziness.To learn more about patient assistance programs for Myrbetriq, please call Astellas Pharma Support SolutionsMyrbetriq, VESIcare, Astellas, and the flying star logo are registered trademarks of Astellas Pharma, Inc. All other trademarks or registered trademarks are the property of their respective owners.This site is intended for US Healthcare Professionals only. In volunteers with moderate hepatic impairment (Child-Pugh Class B), mean Cmax and AUC values were 175% and 65% higher. The pharmacokinetics of MYRBETRIQIn patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of MYRBETRIQNo dose adjustment is necessary based on gender. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; however, Myrbetriq and solifenacin succinate should still be administered with caution to patients with clinically significant BOO. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Monitor serum digoxin concentrations closely to help guide digoxin dosing.Doxepin (Systemic): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Doxepin (Systemic). If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue Myrbetriq and/or solifenacin succinate and initiate appropriate therapy and/or measures necessary to ensure a patent airway.Solifenacin succinate should be administered with caution to patients with decreased gastrointestinal motility, controlled narrow-angle glaucoma or reduced renal or hepatic function. Amphetamines: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amphetamines. Thioridazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Thioridazine. RifAMPin: May decrease the serum concentration of Mirabegron.RisperiDONE: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of RisperiDONE. The website you are linking to is neither owned nor controlled by Astellas. The drug was approved by the US Food and Drug Administration (FDA) in June 2012, for treating the patients with OAB. Revised: July 2017.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.In three, 12-week, double-blind, placebo-controlled, safety and efficacy studies in patients with The most frequent adverse events (0.2%) leading to discontinuation in Studies 1, 2 and 3 for the 25 mg or 50 mg dose were nausea, headache, Table 1 lists adverse reactions, derived from all adverse events, that were reported in Studies 1, 2 and 3 at an incidence greater than placebo and in 1% or more of patients treated with MYRBETRIQOther adverse reactions reported by less than 1% of patients treated with MYRBETRIQTable 2 lists the rates of the most commonly reported adverse reactions, derived from all adverse events in patients treated with MYRBETRIQIn a separate clinical study in Japan, a single case was reported as Because these spontaneously reported events are from the worldwide postmarketing experience, from a population of uncertain size, the frequency of events and the role of mirabegron in their causation cannot be reliably determined.The following events have been reported in association with mirabegron use in worldwide postmarketing experience:There have been postmarketing reports of confusion, hallucinations, insomnia and anxiety in patients taking mirabegron.