Oxybutynin

DRUG INFORMATION

  ADULT
    - ( 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
    - ( 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
    - 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

  CHILD
    - 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
    - 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
    - ( 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - ( 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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