{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "oxybutynin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2 ) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Adults The recommended starting dose of oxybutynin chloride extended-release tablets is 5 mg or 10 mg once daily at approximately the same time each day.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day).",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6-15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). 8.6 Renal Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment. 8.7 Hepatic Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 8.4 ) Renal or Hepatic Impairment: There have been no studies conducted in patients with renal or hepatic impairment.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). 8.6 Renal Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment. 8.7 Hepatic Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "The background risk of major birth defects and miscarriage for the indicated population is unknown.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary There are no data on the presence of oxybutynin in human milk, the effects on the breastfed infant, or the effects of oxybutynin chloride extended-release tablets on milk production.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxybutynin chloride extended-release tablets and any potential adverse effects on the breastfed child from oxybutynin chloride extended-release tablets or from the underlying maternal condition.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      },
      {
        "text": "The background risk of major birth defects and miscarriage for the indicated population is unknown. 8.2 Lactation Risk Summary There are no data on the presence of oxybutynin in human milk, the effects on the breastfed infant, or the effects of oxybutynin chloride extended-release tablets on milk production.",
        "source": "US FDA label for oxybutynin (Oxybutynin Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/oxybutynin.json",
        "verbatim": true
      }
    ]
  }
}