Section 17 · Monograph

Mirabegron

Reviewed Nov 2026FDA label
MyrbetriqBeta-3 agonist
Forms
ER tab: 25, 50mg | Granules (oral suspension)
Dose
Adults: 25mg once daily, increase to 50mg after 4-8 weeks | Pediatric NDO age 3+: weight-based; 35kg or more 25mg daily, up to 50mg after 4-8 weeks, with food
MOA
Beta-3 adrenergic agonism, relaxes detrusor during filling

Indications

  • Overactive bladder in adults (monotherapy or with solifenacin)FDA-labeled
  • Neurogenic detrusor overactivity in pediatric patients 3 years and olderFDA-labeled

Mechanism of Action

  • Beta-3 adrenergic receptor agonist that relaxes the detrusor during bladder filling, increasing capacity

Full Dosing

Adult / usual

  • Swallow tablets whole; do not chew, divide or crush

Renal

  • Adults: 25mg once daily; may increase to 50mg after 4-8 weeks; maximum 25mg/day in severe renal impairment (eGFR 15-29) or moderate hepatic impairment

Pediatric

  • Pediatric NDO age 3+: weight-based; patients 35kg or more may use extended-release tablets 25mg once daily with food, increasing to 50mg after 4-8 weeks; patients under 35kg use granules (not substitutable mg-for-mg)

Contraindications

  • None listed in labeling

Drug Interactions

  • Moderate CYP2D6 inhibition raises metoprolol and desipramine levels
  • Digoxin levels increase — use the lowest digoxin dose
  • May be combined with solifenacin per label

Adverse Effects

  • Increase in blood pressure (hypertension)
  • Urinary tract infection, nasopharyngitis, headache
  • Angioedema
  • Urinary retention in bladder outlet obstruction

Monitoring Parameters

  • Blood pressure periodically
  • Post-void residual in neurogenic bladder

Pregnancy & Lactation

  • Limited data; use only if benefit justifies risk
  • Excreted in milk in animals

References

  1. MYRBETRIQ (mirabegron) Prescribing Information — Astellas

Same class

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