Mirabegron

Selective β3-adrenoceptor agonist for overactive bladder

ATC code: G04BD12

Brand names: Betmiga, Myrbetriq, Vesomni

Updated 27 May 2026 · Methodology

Indications

Overactive bladder

Second line

Second-line for overactive bladder alongside antimuscarinics per EAU 2024 and AUA 2019. Dose 50 mg once daily; start at 25 mg in older adults or with moderate renal/hepatic impairment. Efficacy is comparable to solifenacin and tolterodine (SCORPIO trial), without anticholinergic side effects – preferred in older patients and those intolerant of dry mouth. Combination mirabegron + solifenacin (combined formulation Vesomni) can be used when monotherapy is insufficient.

Sources

ICD-10: N32.8 · ICD-11: GC50.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Anti-aging and longevity

Not recommended

Mirabegron is a selective β3-adrenergic agonist. It is prescribed for overactive bladder (AEMPS Ficha Técnica). Mirabegron is positioned as a modern β3-agonist for anti-aging of the urinary system. No clinical studies of prophylactic use outside overactive bladder exist. The drug can cause hypertension (requires monitoring before and during treatment), urinary retention, tachycardia, headache, and urinary tract infections. If mirabegron was prescribed outside confirmed overactive bladder, consider seeking a second opinion.

Sources

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

A selective β3-adrenoceptor agonist on bladder detrusor. β3 stimulation during filling phase relaxes the detrusor, increases bladder capacity, and reduces involuntary contractions. Unlike antimuscarinics, no anticholinergic side effects (no dry mouth, constipation, or cognitive impairment), but BP and HR may rise – monitoring is needed. CYP3A4- and CYP2D6-metabolized.

Safety

Contraindications

Mirabegron hypersensitivity
Severe uncontrolled hypertension (BP over 180/110)
Severe hepatic impairment
Severe renal impairment (eGFR under 15)

Serious adverse effects

Hypertensive crisis
Acute urinary retention in patients with outflow obstruction
QT prolongation (rare)
Severe allergic reactions, angioedema
Serious cardiovascular events

Common adverse effects

Tachycardia
Increased BP
Urinary tract infections
Headache
Nasopharyngitis
Constipation

Pregnancy: can you take Mirabegron?

Limited pregnancy data. OAB in pregnancy usually does not require pharmacotherapy – behavioral measures are first-line. When treatment is needed, defer to postpartum.

Breastfeeding: can you take Mirabegron?

No data on milk excretion. Not used during lactation.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take once daily, with or without food, preferably at the same time. Check BP before start and again at 4 weeks – mirabegron raises systolic BP by 1–2 mmHg on average, more in some patients. Not used in uncontrolled hypertension (BP over 180/110). Strong CYP3A4 and CYP2D6 inhibitors may raise levels – cap dose at 25 mg in such combinations.

Label mentions21 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

MajorDigoxin
«DRUG INTERACTIONS: Digoxin: When initiating a combination of mirabegron and digoxin with or without solifenacin succinate, use the lowest dose of digoxin; monitor serum digoxin concentrations to…»
FDA, section 7 · Open on DailyMed
Moderateantiarrítmicosclass named in the label
«Se recomienda precaución si mirabegrón se administra de forma concomitante con medicamentos que tienen un estrecho margen terapéutico y que sean metabolizados de forma significativa por el CYP2D6…»
AEMPS, section 4.5 · Open on CIMA
Moderateantidepresivos tricíclicosclass named in the label
«Se recomienda precaución si mirabegrón se administra de forma concomitante con medicamentos que tienen un estrecho margen terapéutico y que sean metabolizados de forma significativa por el CYP2D6…»
AEMPS, section 4.5 · Open on CIMA
ModerateClarithromycin
«En voluntarios sanos, la exposición de mirabegrón (AUC) se incrementó 1,8 veces en presencia del potente inhibidor del CYP3A/P-gp, ketoconazol. No se requiere ajuste de dosis cuando mirabegrón se…»
AEMPS, section 4.5 · Open on CIMA
ModerateDabigatran
«Mirabegrón es un inhibidor débil de P-gp. Mirabegrón aumentó la C máx y el AUC hasta un 29% y 27% respectivamente, de la digoxina, sustrato de P-gp en voluntarios sanos. Para los pacientes que están…»
AEMPS, section 4.5 · Open on CIMA
ModerateDigoxin
«Mirabegrón es un inhibidor débil de P-gp. Mirabegrón aumentó la C máx y el AUC hasta un 29% y 27% respectivamente, de la digoxina, sustrato de P-gp en voluntarios sanos. Para los pacientes que están…»
AEMPS, section 4.5 · Open on CIMA
ModerateFlecainide
«Se recomienda precaución si mirabegrón se administra de forma concomitante con medicamentos que tienen un estrecho margen terapéutico y que sean metabolizados de forma significativa por el CYP2D6…»
AEMPS, section 4.5 · Open on CIMA
Moderateinhibidores del CYP3A4class named in the label
«En voluntarios sanos, la exposición de mirabegrón (AUC) se incrementó 1,8 veces en presencia del potente inhibidor del CYP3A/P-gp, ketoconazol. No se requiere ajuste de dosis cuando mirabegrón se…»
AEMPS, section 4.5 · Open on CIMA
ModerateItraconazole
«En voluntarios sanos, la exposición de mirabegrón (AUC) se incrementó 1,8 veces en presencia del potente inhibidor del CYP3A/P-gp, ketoconazol. No se requiere ajuste de dosis cuando mirabegrón se…»
AEMPS, section 4.5 · Open on CIMA
ModerateKetoconazole
«En voluntarios sanos, la exposición de mirabegrón (AUC) se incrementó 1,8 veces en presencia del potente inhibidor del CYP3A/P-gp, ketoconazol. No se requiere ajuste de dosis cuando mirabegrón se…»
AEMPS, section 4.5 · Open on CIMA
Moderatemedicamentos que prolongan el QTclass named in the label
«Pacientes con prolongación congénita o adquirida del intervalo QT: Mirabegrón, a dosis terapéuticas, no ha demostrado prolongación del intervalo QT clínicamente relevante en los ensayos clínicos (ver…»
AEMPS, section 4.4 · Open on CIMA
ModeratePropafenone
«Se recomienda precaución si mirabegrón se administra de forma concomitante con medicamentos que tienen un estrecho margen terapéutico y que sean metabolizados de forma significativa por el CYP2D6…»
AEMPS, section 4.5 · Open on CIMA
ModerateRitonavir
«En voluntarios sanos, la exposición de mirabegrón (AUC) se incrementó 1,8 veces en presencia del potente inhibidor del CYP3A/P-gp, ketoconazol. No se requiere ajuste de dosis cuando mirabegrón se…»
AEMPS, section 4.5 · Open on CIMA
Minorinductores del CYP3A4class named in the label
«Las sustancias que son inductores del CYP3A o P-gp disminuyen las concentraciones plasmáticas de mirabegrón. No se requiere ajuste de dosis para mirabegrón cuando se administre con dosis terapéuticas…»
AEMPS, section 4.5 · Open on CIMA
MinorRifampicin
«Las sustancias que son inductores del CYP3A o P-gp disminuyen las concentraciones plasmáticas de mirabegrón. No se requiere ajuste de dosis para mirabegrón cuando se administre con dosis terapéuticas…»
AEMPS, section 4.5 · Open on CIMA
hormonal contraceptivesclass named in the label
«DRUG INTERACTIONS: Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on…»
FDA, section 7 · Open on DailyMed
Ketoconazole
«DRUG INTERACTIONS: Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on…»
FDA, section 7 · Open on DailyMed
Metoprolol
«Interacciones farmacológicas: El efecto de los fármacos administrados conjuntamente sobre la farmacocinética de mirabegrón y el efecto de mirabegrón sobre la farmacocinética de otros medicamentos fue…»
AEMPS, section 4.5 · Open on CIMA
Tamsulosin
«DRUG INTERACTIONS: Drug interaction studies were conducted in adult patients to investigate the effect of coadministered drugs on the pharmacokinetics of mirabegron and the effect of mirabegron on…»
FDA, section 7 · Open on DailyMed
Warfarin
«Warfarin: The mean C max of S - and R -warfarin was increased by approximately 4% and AUC by approximately 9% when administered as a single dose of 25 mg after multiple doses of 100 mg mirabegron…»
FDA, section 7 · Open on DailyMed

From other drugs’ labels

Digoxin
«Pharmacokinetic Drug Interactions: Mirabegron 29% 27%»
FDA, section 7 · Open on DailyMed

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Frequently asked

What is Mirabegron used for?

Mirabegron is evaluated for the following indications with varying evidence strength: Overactive bladder (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Mirabegron?

Common side effects of Mirabegron (≥ 1 in 100): Tachycardia, Increased BP, Urinary tract infections, Headache, Nasopharyngitis, Constipation. See the Safety section for uncommon and serious reactions.

Is Mirabegron safe during pregnancy?

Limited pregnancy data. OAB in pregnancy usually does not require pharmacotherapy – behavioral measures are first-line. When treatment is needed, defer to postpartum.

Is Mirabegron compatible with breastfeeding?

No data on milk excretion. Not used during lactation.

Who should not take Mirabegron?

Mirabegron is contraindicated in: Mirabegron hypersensitivity; Severe uncontrolled hypertension (BP over 180/110); Severe hepatic impairment; Severe renal impairment (eGFR under 15). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 03/11/2026
EMALabel dated 12/20/2012
FDA / DailyMedLabel dated 05/22/2026

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