Oxybutynin

Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle.

• Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).ICD-10: N32.81

• Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.contraindicated

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. (2) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day. ( 2.1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. ( 2.2 ) 2.1 Adults The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. 2.2 Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).

Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. ( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin. If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets. ( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson's disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy. ( 5.4 ) Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention ( 5.5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. ( 5.6 ) 5.1 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening.

The most common (incidence ≥5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of Oxybutynin chloride extended-release tablets (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Oxybutynin chloride IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1.

Pediatric Use: Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing or crushing, or in children under the age of 6 years. (8.4) Renal or Hepatic Impairment: There have been no studies conducted in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) 8.1 Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. Animal Data Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. 8.3 Nursing Mothers It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin chloride extended-release tablets are administered to a nursing woman.

Metabolism

Absorption Following the first dose of Oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from Oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin.

The continuous release of oxybutynin from Oxybutynin chloride extended-release tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

• Nov 14, 1988ANDAANDA071655Teva Pharms Usa
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• Feb 26, 2003NDANDA021351Allergan
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• Jan 25, 2013NDANDA202211Abbvie

1. 1Drug Ineffective4,61012%
2. 2Fatigue2,2436.0%
3. 3Fall2,0425.5%
4. 4Nausea1,7904.8%
5. 5Off Label Use1,6134.3%
6. 6Diarrhoea1,5844.3%
7. 7Dizziness1,5664.2%
8. 8Pain1,5494.2%
9. 9Headache1,5234.1%
10. 10Urinary Tract Infection1,4784.0%
11. 11Asthenia1,2703.4%
12. 12Pruritus1,2233.3%
13. 13Constipation1,1213.0%
14. 14Gait Disturbance1,0642.9%
15. 15Dyspnoea1,0632.9%

The 10 most recently updated of 111 ClinicalTrials.gov registrations naming Oxybutynin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
  Recruiting · Phase 2 · Interventional · 50 enrolled · University Hospital, Bordeaux
  NCT04526353updated 2026-06-10
• A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
  Completed · Observational · 999 enrolled · Astellas Pharma Global Development, Inc.
  NCT06049797updated 2026-06-05
• Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis
  Completed · Early phase 1 · Interventional · 25 enrolled · Thanakrit Visuthikosol
  NCT07016451updated 2026-05-15
• Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Brigham and Women's Hospital
  NCT07577661updated 2026-05-11
• The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.
  Active not recruiting · Phase 1 · Interventional · 107 enrolled · Rakitzi, Stavroula
  NCT06993662updated 2026-05-07
• Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.
  Active not recruiting · Phase 4 · Interventional · 84 enrolled · Dr. Stavroula Rakitzi
  NCT07047651updated 2026-05-01
• Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
  Active not recruiting · Interventional · 126 enrolled · Northwestern University
  NCT05100017updated 2026-04-30
• Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
  Completed · Phase 4 · Interventional · 45 enrolled · China Medical University Hospital
  NCT06295562updated 2026-04-23
• Efficacy of Intravesical Oxybutynin in Children With Neurogenic Bladder Dysfunction
  Recruiting · Phase 3 · Interventional · 60 enrolled · Central Hospital, Nancy, France
  NCT07027020updated 2026-04-14
• Endotype DIrected Treatment for OSA in Down Syndrome
  Recruiting · Phase 4 · Interventional · 200 enrolled · University of Arizona
  NCT07280468updated 2026-04-07

Frequently asked questions

How does Oxybutynin work?

Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle.

What is Oxybutynin used for?

According to FDA labeling, Oxybutynin carries indications including: Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxybutynin?

Oxybutynin is classified as Drugs for urinary frequency and incontinence, Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists, Decreased Large Intestinal Muscle Tone, Decreased Small Intestinal Muscle Tone, Decreased Smooth Muscle Acetylcholine Activity.

What are the brand names for Oxybutynin?

Oxybutynin is marketed under brand names including Ditropan, Gelnique, Oxytrol.

What are the contraindications for Oxybutynin?

Oxybutynin labeling lists contraindications including: Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.. Always consult the full prescribing information and a clinician.