Mirabegron

DRUG INFORMATION

  ADULT
    - OAB in Adults The recommended starting dose of mirabegron extended-release tablets
      is 25 mg orally once daily.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) After 4 to 8 weeks, the mirabegron extended-release tablets dose may be
      increased to 50 mg orally once daily.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29
    - After 4 to 8 weeks, the mirabegron extended-release tablets dose may be increased
      to 50 mg orally once daily.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness have been established only for the following
      pediatric indications: Mirabegron: Treatment of neurogenic detrusor overactivity
      (NDO) in pediatric patients 3years of age and older and weighing 35 kg or more.
      Source: US FDA label for mirabegron (Mirabegron), section 'pediatric use',
      retrieved 2026-08-29
    - Mirabegron extended-release tablets and Mirabegron Granules are two different
      products and they are not substitutable on a milligram-per-milligram basis. Select
      the recommended product (Mirabegron extended-release tablets and Mirabegron
      Granules) based on the indication and patient's weight. OAB in Adults The
      recommended starting dose of mirabegron extended-release tablets is 25 mg orally
      once daily.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) NDO in Pediatric Patients 3 Years and Older Pediatric Patients weighing 35
      kg or more: Use mirabegron extended-release tablets: The recommended starting
      dosage of mirabegron extended-release tablets is 25 mg orally once daily.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - For administration instructions, see Dosage and Administration (2.7) . 2.4
      Recommended Dosage in Adult Patients with Renal or Hepatic Impairment Dosage in
      Adults with Renal Impairment The recommended dosage of mirabegron extended-release
      tablets (administered orally once daily) in adult patients with renal impairment
      is described in Table 1 [see Use in Specific Populations ( 8.6 )].
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for mirabegron (Mirabegron),
      section 'dosage and administration', retrieved 2026-08-29
    - Table 1: Mirabegron Extended-Release Tablets Recommended Dosage in Adult Patients
      with Renal Impairment (Administered Orally Once Daily) Estimated GFR 1 Starting
      Dose Maximum Dose eGFR 30 to 89 mL/min/1.73 m 2 25 mg 50 mg eGFR 15 to 29
      mL/min/1.73 m 2 25 mg 25 mg eGFR < 15 mL/min/1.73 m 2 or requiring dialysis Not
      Recommended 1.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for mirabegron (Mirabegron),
      section 'dosage and administration', retrieved 2026-08-29
    - Pediatric Patients weighing 35 kg or more with renal or hepatic impairment: Use
      Mirabegron Extended-Release Tablets Dosage in Pediatric Patients with Renal
      Impairment The recommended dosage of mirabegron extended-release tablets in
      pediatric patients with renal impairment weighing 35 kg or more (administered
      orally once daily) is described in Table 1 (above).
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for mirabegron (Mirabegron),
      section 'dosage and administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 2.3 ) Adult or Pediatric Patients Patients with Renal or Hepatic Impairment :
      Refer to the full prescribing information for recommended dosage.
      Source: US FDA label for mirabegron (Mirabegron), section 'dosage and
      administration', retrieved 2026-08-29
    - For administration instructions, see Dosage and Administration (2.7) . 2.4
      Recommended Dosage in Adult Patients with Renal or Hepatic Impairment Dosage in
      Adults with Renal Impairment The recommended dosage of mirabegron extended-release
      tablets (administered orally once daily) in adult patients with renal impairment
      is described in Table 1 [see Use in Specific Populations ( 8.6 )].
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for mirabegron (Mirabegron),
      section 'dosage and administration', retrieved 2026-08-29
    - Estimated GFR using the modification of diet in renal disease (MDRD) formula
      Dosage in Adults with Hepatic Impairment The recommended dosage of mirabegron
      extended-release tablets (administered orally once daily) in adult patients with
      hepatic impairment is described in Table 2 [see Use in Specific Populations ( 8.7
      )].
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for mirabegron (Mirabegron),
      section 'dosage and administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no studies with the use of mirabegron in pregnant women or
      adolescents to inform a drug-associated risk of major birth defects, miscarriages,
      or adverse maternal or fetal outcomes.
      Source: US FDA label for mirabegron (Mirabegron), section 'pregnancy', retrieved
      2026-08-29
    - Mirabegron administration to pregnant animals during organogenesis resulted in
      reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum
      recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in
      rabbits) at 14-fold the MRHD.
      Source: US FDA label for mirabegron (Mirabegron), section 'pregnancy', retrieved
      2026-08-29
    - At maternally-toxic exposures in rats (96-fold), decreased fetal weight and
      increased fetal mortality were observed and, in rabbits (36-fold), cardiac
      findings (fetal cardiomegaly and fetal dilated aortae) were observed [see Data].
      Source: US FDA label for mirabegron (Mirabegron), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of mirabegron in human milk, the
      effects on the breastfed child, or the effects on milk production.
      Source: US FDA label for mirabegron (Mirabegron), section 'nursing mothers',
      retrieved 2026-08-29
    - Mirabegron-related material was present in rat milk and in the stomach of nursing
      pups following administrations of a single 10 mg/kg oral dose of 14 C-labeled
      mirabegron to lactating rats.
      Source: US FDA label for mirabegron (Mirabegron), section 'nursing mothers',
      retrieved 2026-08-29
    - When a drug is present in animal milk, it is likely that the drug will be present
      in human milk.
      Source: US FDA label for mirabegron (Mirabegron), section 'nursing mothers',
      retrieved 2026-08-29