{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "mirabegron",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/mirabegron.json",
        "verbatim": true
      }
    ]
  }
}