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BetmigaTM (mirabegron) is indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome and for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to < 18 years.1
Median time to discontinuation was longer with BETMIGA (169 days) compared with tolterodine (56 days) and other antimuscarinics (30–78 days)12
In a retrospective, longitudinal cohort study of UK patients who received a prescription for a target OAB medication, patients on BETMIGA showed significantly higher persistence at 12 months vs those on antimuscarinics:*7,12
*p<0.001 for BETMIGA vs each antimuscarinics.12
CI, confidence interval; ER, extended release; IR, immediate release; OAB, overactive bladder.
Hypersensitivity to the active substance(s) or to any of the excipients.1
Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.1
*BETMIGA can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with BETMIGA, especially in hypertensive patients. BETMIGA is contraindicated in patients with severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.1 Please consult the Summary of Product Characteristics for further information.1
†0.2 mmHg and ~1 bpm increases in blood pressure and heart rate, respectively with BETMIGA vs tolterodine.11
β3, beta-3 adrenergic receptor; CV, cardiovascular.
In a retrospective real-world evidence study, 152,026 adverse CV occurrences for each new use of BETMIGA or antimuscarinics were matched10
No increased risk of adverse CV outcomes vs antimuscarinics^10
A diverse group of patients were assessed, including elderly patients and those with CV comorbidities including hypertension10
No higher risk of MACE and its components or all-cause mortality was noted among current users of BETMIGA relative to current users of antimuscarinics^10
BETMIGA can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with BETMIGA, especially in hypertensive patients. BETMIGA is contraindicated in patients with severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.1 Please consult the Summary of Product Characteristics for further information.1
*The number of AMI, stroke and CV mortality cases do not sum to the number of MACE cases. For patients with more than one of the individual outcomes, the earliest individual outcome was counted towards the MACE total.10
^Antimuscarinics studied: solifenacin, oxybutynin, tolterodine, fesoterodine, trospium, darifenacin.10
AMI, acute myocardial infarction; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MACE, major adverse cardiovascular events.
Across 12 months, small mean increases in heart rate were observed in BETMIGA 50 mg vs tolterodine ER 4 mg
BETMIGA can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with BETMIGA, especially in hypertensive patients. BETMIGA is contraindicated in patients with severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.1 In OAB patients (mean age of 59 years) across three 12-week phase 3 double blind, placebo-controlled studies receiving BETMIGA 50 mg once daily, an increase in mean difference from placebo of approximately 1 bpm for pulse rate and approximately 1mm Hg or less in systolic blood pressure/diastolic blood pressure (SBP/DBP) was observed. Changes in pulse rate and blood pressure are reversible upon discontinuation of treatment.13 Please consult the Summary of Product Characteristics for further information.1 AE, adverse event; bpm, beats per minute; DBP, diastolic blood pressure; ER, extended release; OAB, overactive bladder; SBP, systolic blood pressure.
The safety of Betmiga was evaluated in 8,433 adult patients with OAB, of which 5,648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga 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 this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity.
*observed during post-marketing experience
The safety of mirabegron tablets and oral suspension was evaluated in 86 paediatric patients aged 3 to less than 18 years with neurogenic detrusor overactivity in a 52-week, open-label, baseline-controlled, multicentre, dose titration study. The most commonly reported adverse reactions observed in the paediatric population were urinary tract infection, constipation, and nausea. In the paediatric patients with NDO, no severe adverse reactions were reported.
The safety of mirabegron tablets and oral suspension was evaluated in 26 paediatric patients aged 5 to less than 18 years of age with overactive bladder in a 12-week, double-blind, randomised, multicentre, parallel group, placebo-controlled sequential dose titration study. The most commonly reported adverse reactions observed in the paediatric population were nasopharyngitis, fatigue and mood swing.
Overall, the safety profile in children and adolescents is similar to that observed in adults.
References
1. BETMIGA (mirabegron) prolonged-release tablets. Summary of Product Characteristics. 2. Khullar V, et al. Eur Urol. 2013;63:283–295. 3. Yamaguchi O, et al. BJU Int. 2014;113(6):951–960. 4. Kuo H-C, et al. Neurourol Urodyn. 2015;34(7):685–692. 5. Nitti VW, et al. J Urol. 2013;189(4):1388–1395. 6. Yamaguchi O, et al. Low Urin Tract Symptoms. 2017;9(1):38–45. 7. Herschorn S, et al. Health Qual Life Outcomes. 2018;16(1):69. 8. Kakizaki H, et al. Eur Urol Focus. 2020;6:729–737. 9. Wagg A, et al. Eur Urol. 2020;77(2):211–220. 10: Hoffman V, et al. Drug Saf. 2021;44(8):899–915. 11. Hadi FA, et al. Eur Urol Open Sci. 2025;82:91–99. 12. Chapple CR, et al. Eur Urol. 2017;72:389–399 13. Chapple CR, et al. Eur Urol. 2013;63(2):296–305 14. Chapple CR, et al. Eur Urol. 2020;77:119–128
Adverse events should be reported. For Ireland, Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: www.hpra.ie or Astellas Pharma Co. Ltd. Tel:+353 1 467 1555, E-mail: irishdrugsafety@astellas.com.
MAT-IE-BET-2026-00004 Sep 2026
