Uses
OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.
Source: US FDA prescribing information
- Presentations
- 8
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Oxybutynin is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. It is available as extended-release tablets, tablets and oral solution for transdermal use. MedsAcross supplies Oxybutynin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists
- ATC classification
- G04BD04 Oxybutynin · Urology medicines, subgroup G04B, subgroup G04BD
- US FDA first approval
- 16 July 1975
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral, Transdermal
- Dosage forms
- Extended-release tablet, Tablet, Oral solution, Syrup, Transdermal patch
- Identifiers
- UNII L9F3D9RENQRxCUI 54251CAS 1508-65-2DrugBank DBSALT000430Q27107600
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The free base form of oxybutynin is pharmacologically equivalent to oxybutynin hydrochloride. Oxybutynin acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In patients with conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction. Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The active metabolite, N-desethyloxybutynin, has pharmacological activity on the human detrusor muscle that is similar to that of oxybutynin in in vitro studies.
Source: US FDA prescribing information
Dosing overview
OXYTROL 3.9 mg/day should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days). A new application site should be selected with each new transdermal system to avoid re-application to the same site within 7 days. Do not divide or cut the transdermal system into pieces. Do not use if the transdermal system is damaged. Apply OXYTROL transdermal system twice weekly (every 3 to 4 days) to dry, intact skin on the abdomen, hip, or buttocks. Select a new application site with each new transdermal system to avoid re-application to the same site within 7 days.
Source: US FDA prescribing information
Contraindications
The use of OXYTROL is contraindicated in the following conditions: Urinary retention Gastric retention Uncontrolled narrow-angle glaucoma Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL. Urinary retention. Gastric retention. Uncontrolled narrow-angle glaucoma. Known serious hypersensitivity reaction to OXYTROL, oxybutynin, or to any of the components of OXYTROL
Source: US FDA prescribing information
Warnings and precautions
Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. Central Nervous System Effects: Somnolence has been reported with products containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue OXYTROL and initiate appropriate therapy. Skin Hypersensitivity: Discontinue OXYTROL in patients with skin hypersensitivity.
Source: US FDA prescribing information
Side effects
The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth.
Source: US FDA prescribing information
Interactions
No specific drug-drug interaction studies have been performed with OXYTROL. Other Anticholinergics (muscarinic antagonists): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects.
Source: US FDA prescribing information
Storage
Storage Store at 20-25°C (68-77°F). Protect from moisture and humidity. Do not store outside the sealed pouch.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
8 presentations of Oxybutynin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Oxybutynin 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 5 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 10 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 15 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 5 mg/5 mL oral solutionOralGeneric name | — | US FDA | Available on request |
| Oxybutynin 5 mg/5 mL syrupOralGeneric name | — | US FDA | Available on request |
| Oxytrol 3.9 mg/day transdermal patchTransdermal | Allergan | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Oxybutynin available for export from India?
Yes, on request. MedsAcross lists 8 presentations of Oxybutynin and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Oxybutynin have?
The catalogue lists 1 brand names for Oxybutynin, including Oxytrol.
Is Oxybutynin approved by the US FDA?
Yes. The US FDA first approved Oxybutynin on 16 July 1975, according to Drugs@FDA.
Is Oxybutynin authorised in the European Union?
Yes. Oxybutynin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Oxybutynin need cold chain shipping?
No listed presentation of Oxybutynin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Oxybutynin in?
Oxybutynin is classified under ATC code G04BD04 (Oxybutynin).
References
- OXYTROL prescribing information (Allergan). U.S. National Library of Medicine, DailyMed. Retrieved 29 May 2024
- Kentera (previously Oxybutynin Nicobrand): European public assessment report (EPAR). European Medicines Agency. Retrieved 8 April 2025
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