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Oxybutynin

Oxybutynin is a bladder-calming medication used to treat overactive bladder, urge urinary incontinence, and related bladder control symptoms across several oral and transdermal products.

Brand names Ditropan XLDitropanOxytrolGelniqueOxybutynin Chloride +2 more
Drug class Cholinergic Muscarinic Antagonist
Rx/OTC Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 86 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Transdermal
Oxybutynin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Oxybutynin is one of the oldest, most familiar medicines for overactive bladder, blocking the nerve signals that make the bladder muscle squeeze so it spasms less and holds more; on the U.S. market since about 1990, it is available generically and comes as tablets, liquid, a patch or gel. Most people tolerate it, though dry mouth and constipation are common, and the extended-release tablet, patch and gel usually cause less dry mouth than the immediate-release forms. Get emergency help for swelling of the face, lips, tongue or throat (angioedema), and tell your prescriber about new confusion, hallucinations or trouble passing urine, especially in older adults or anyone with dementia.

Clinical pearls

  • Swallow the extended-release tablet whole and never crush, chew or split it, even when it feels hard to swallow.
  • Some antibiotics and antifungals, such as clarithromycin, erythromycin, ketoconazole and itraconazole, can raise oxybutynin levels considerably.
  • Pairing it with other drying medicines, such as diphenhydramine in many sleep aids, piles on dry mouth, constipation and drowsiness.
  • Anyone taking donepezil or a similar dementia medicine should make sure the prescriber knows, since oxybutynin can worsen memory and confusion.
How we write & review this content — our editorial policy →
How you get itPrescription and over the counter
Comes asExtended-release tablet, Tablet, Oral solution +1
Earliest FDA record1975
Companies listing it with the FDA40
FDA label last updatedNov 7, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Oxybutynin, written from its FDA label.

What Oxybutynin is used for

▾

Oxybutynin is approved for several bladder conditions across its different products and formulations.

  • Overactive bladder with urge incontinence, urgency, and frequent urination — approved for extended-release tablets (Oxybutynin Chloride) in adults
  • Overactive bladder in men — approved specifically for Oxytrol skin patch
  • Overactive bladder in women 18 and older — approved specifically for Oxytrol for Women skin patch
  • Bladder instability symptoms (urgency, frequency, leakage, urge incontinence, painful urination) in patients with neurogenic bladder — approved for Oxybutynin Chloride tablets and oral solution
  • Detrusor overactivity (overactive bladder muscle) due to a neurological condition such as spina bifida in children 6 and older — approved for Oxybutynin Chloride extended-release tablets

How Oxybutynin works

▾

Oxybutynin works by blocking muscarinic receptors — the chemical targets that acetylcholine (a nerve messenger) uses to trigger bladder muscle contractions. By blocking these signals, oxybutynin relaxes the bladder's smooth muscle wall, reduces unwanted spasms, increases the bladder's capacity to hold urine, and pushes back the sensation of urgency. An active breakdown product in the body, desethyloxybutynin, contributes similar effects on the bladder muscle.

Oxybutynin dosage

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How and how often you take oxybutynin depends on the form prescribed.

  • Extended-release tablets (Oxybutynin Chloride): Taken once daily by mouth, with or without food. Tablets must be swallowed whole — never chewed, crushed, or split.
  • Immediate-release tablets and oral solution (Oxybutynin Chloride): Taken multiple times a day by mouth. A lower starting frequency may be recommended for frail elderly patients.
  • Oxytrol skin patch: Applied to the skin twice weekly (every 3–4 days). Rotate the site each time.
  • Oxytrol for Women skin patch: Applied to the skin and changed every 4 days. Rotate the site each time.

Always take oxybutynin at roughly the same time each day or on the same schedule each week, and follow your prescriber's specific instructions.

Dosing details from the FDA-approved label

From the Oxybutynin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults (oxybutynin chloride extended-release tablets, oral)
    • Start with 5 mg or 10 mg once daily at approximately the same time each day
    • Dosage may be adjusted in 5-mg increments, in general at approximately weekly intervals
    • Maximum: 30 mg/day
    • Swallow whole with liquids; do not chew, divide, or crush; may be taken with or without food
  • Pediatric patients 6 years of age and older (oxybutynin chloride extended-release tablets, oral)
    • Start with 5 mg once daily at approximately the same time each day
    • Dosage may be adjusted in 5-mg increments
    • Maximum: 20 mg/day
    • Swallow whole with liquids; do not chew, divide, or crush; may be taken with or without food
  • Adults (oxybutynin chloride immediate-release tablet, oral)
    • One 5-mg tablet two to three times a day
    • Maximum: One 5-mg tablet four times a day
  • Frail elderly (oxybutynin chloride immediate-release tablet, oral)
    • Lower starting dose of 2.5 mg two or three times a day
    • Frail elderly
  • Pediatric patients over 5 years of age (oxybutynin chloride immediate-release tablet, oral)
    • One 5-mg tablet two times a day
    • Maximum: One 5-mg tablet three times a day
  • Adults (oxybutynin chloride oral solution and syrup)
    • One teaspoon (5 mg/5 mL) two to three times a day
    • Frail elderly: lower starting dose of 2.5 mg two or three times a day
    • Maximum: One teaspoon (5 mg/5 mL) four times a day
    • Lower starting dose recommended for the frail elderly
  • Pediatric patients over 5 years of age (oxybutynin chloride oral solution and syrup)
    • One teaspoon (5 mg/5 mL) two times a day
    • Maximum: One teaspoon (5 mg/5 mL) three times a day
  • Oxytrol transdermal system (3.9 mg/day)
    • Apply one system twice weekly (every 3 or 4 days) to dry, intact skin on the abdomen, hip, or buttock
    • Select a new application site each time to avoid re-application to the same site within 7 days; do not divide or cut; do not use if damaged
  • Women 18 years of age and older (Oxytrol for Women patch)
    • Wear only 1 patch at a time for 4 days in a row
    • After 4 days remove the used patch and apply a new one, changing it every 4 days
    • Apply to clean, dry, smooth skin on abdomen, hips or buttocks; change the site with each new patch; do not cut the patch
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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. ( Error! Hyperlink reference not valid. ) • 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 tablet 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 tablet 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).

Read the full Dosage and Administration section on DailyMed →

Oxybutynin side effects

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The most frequently reported side effects include:

Common side effects

  • Dry mouth
  • Constipation
  • Diarrhea
  • Headache
  • Drowsiness (somnolence)
  • Dizziness
  • Blurred vision
  • Nausea
  • Dry eyes or dry skin

When to get medical help

  • Seek emergency help if you notice swelling of the face, lips, tongue, or throat (angioedema) — this can block your airway
  • Call your doctor if you experience hallucinations, confusion, agitation, or unusual behavior
  • Tell your doctor right away if you cannot urinate (urinary retention)
  • Seek help for a fast or irregular heartbeat (arrhythmia or tachycardia)
  • Call your doctor if you have signs of a severe allergic reaction such as hives, rash, or difficulty breathing
  • Do not drive or operate heavy machinery until you know how oxybutynin affects you — drowsiness and dizziness are possible

More serious reactions that need prompt attention include swelling of the face, lips, tongue, or throat; hallucinations or confusion; inability to urinate; fast or irregular heartbeat; and signs of a severe allergic reaction such as hives or difficulty breathing — contact your doctor or seek emergency care right away if any of these occur.

Oxybutynin warnings and precautions

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  • Angioedema (throat swelling): Swelling of the face, lips, tongue, or throat has been reported, sometimes after the very first dose. Swelling that affects the airway can be life-threatening. Stop oxybutynin and get emergency help immediately.
  • Brain/CNS anticholinergic effects: Oxybutynin can cause hallucinations, confusion, agitation, memory problems, and drowsiness — especially in the first few months or after a dose increase. Do not drive or use heavy machinery until you know how it affects you.
  • Urinary retention: Because oxybutynin relaxes the bladder, it can worsen outflow obstruction and make it difficult or impossible to urinate. Use with caution if you have bladder outflow problems.
  • Gastrointestinal slowing: Oxybutynin slows gut movement and should be used carefully in people with reflux, intestinal narrowing, ulcerative colitis, or intestinal nerve damage (autonomic neuropathy).
  • Worsening of other conditions: Use with caution in Parkinson's disease, myasthenia gravis, and dementia treated with cholinesterase inhibitors — oxybutynin may aggravate all of these.

Oxybutynin interactions

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Oxybutynin can interact with several types of medications that affect how it works or how safe it is to use.

  • Other anticholinergic drugs: Combining oxybutynin with other medications that have anticholinergic effects can multiply side effects like dry mouth, constipation, and confusion.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin): These drugs slow oxybutynin's breakdown in the body, raising its blood levels and potentially increasing side effects.
  • Prokinetic agents (e.g., metoclopramide): Oxybutynin can counteract these gut-stimulating drugs, reducing their effectiveness.
  • Drugs with a narrow therapeutic index: Because oxybutynin slows gut movement, it may alter how quickly some medications are absorbed — which matters for drugs where the dose must be very precise.

Interactions listed in the FDA-approved label

From the Oxybutynin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Other anticholinergic drugs or agents producing dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects: May increase the frequency and/or severity of such effects.
  • Concomitantly administered drugs (absorption affected by anticholinergic effects on gastrointestinal motility): Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs, which may be of concern for drugs with a narrow therapeutic index.
  • Prokinetic agents, such as metoclopramide: Anticholinergic agents may antagonize the effects of prokinetic agents.
  • Ketoconazole (potent CYP3A4 inhibitor): Mean oxybutynin chloride plasma concentrations were approximately 2 fold higher when extended-release tablet was administered with ketoconazole.
  • Other CYP3A4 inhibitors, such as antimycotic agents (itraconazole, miconazole) and macrolide antibiotics (erythromycin, clarithromycin): May alter oxybutynin mean pharmacokinetic parameters (Cmax and AUC); the clinical relevance is not known. Caution should be used when such drugs are co-administered.
Read the label’s full interactions text

7 DRUG INTERACTIONS The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 2 fold higher when oxybutynin chloride extended-release tablet was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered. • Co-administration with other anticholinergic drugs may increase the frequency and/or severity of anticholinergic-like effects. ( Error! Hyperlink reference not valid. ) • Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole) increases the systemic exposure of oxybutynin. ( Error! Hyperlink reference not valid. )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿165 supplements and herbs with documented Oxybutynin interactions, ranked by severity Check Oxybutynin against a supplement or herb →

Before taking Oxybutynin

▾
  • Do not take oxybutynin if you have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or a known allergy to oxybutynin or any component of the product.
  • Tell your doctor about bladder outflow obstruction, gastrointestinal narrowing, ulcerative colitis, or intestinal atony before starting.
  • Use with caution if you have Parkinson's disease, myasthenia gravis, or dementia treated with cholinesterase inhibitors.
  • Tell your doctor if you have autonomic neuropathy, as oxybutynin may worsen slowed gut movement.
  • Tell your doctor if you have acid reflux or take bisphosphonates (bone medications) — oxybutynin may worsen esophagitis.
  • Pregnancy: There are no adequate safety data for oxybutynin use during pregnancy. Discuss risks and benefits with your doctor.
  • Breastfeeding: It is unknown whether oxybutynin passes into breast milk. Discuss with your doctor.
  • Children: Extended-release tablets are not recommended in children under 6 or in children who cannot swallow tablets whole without chewing or crushing.
  • Older adults: Anticholinergic side effects occur at similar rates in those under and over 65, but care is still warranted given the CNS effects.
  • Kidney or liver impairment: No studies have been conducted in patients with kidney or liver impairment — consult your prescriber.

Oxybutynin overdose

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Taking too much oxybutynin can cause anticholinergic toxicity — signs include agitation, confusion, flushing, fever, dehydration, fast or irregular heartbeat, vomiting, and inability to urinate. Because extended-release tablets continue releasing the drug after ingestion, monitoring for at least 24 hours is recommended. Treatment is supportive — seek emergency medical care immediately if overdose is suspected.

What Oxybutynin does in the body

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In people with overactive bladder or neurogenic bladder conditions, oxybutynin measurably increases the bladder's maximum capacity, reduces the frequency of unwanted bladder muscle contractions, and delays the first feeling of needing to urinate. These effects work together to give people better control and fewer urgent trips to the bathroom.

How your body processes Oxybutynin

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After taking extended-release tablets, oxybutynin blood levels rise over several hours and then remain steady for up to 24 hours — providing consistent coverage throughout the day. Oxybutynin is broken down mainly by the liver enzyme CYP3A4, and less than 0.1% of the dose leaves the body unchanged in the urine. Food does not significantly affect how the extended-release tablet is absorbed. An active metabolite called desethyloxybutynin is produced during breakdown and contributes to the drug's bladder effects.

How to store Oxybutynin

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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from moisture and humidity. Keep out of reach of children.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

165

Supplements & herbs that interact with Oxybutynin

165 supplements and herbal products have documented interactions with Oxybutynin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 116
  • Minor · 44
ACTIVATED CHARCOAL Major GRAPEFRUIT Major HENBANE Major SCOPOLIA Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate +157 more
Every supplement checked against Oxybutynin — ranked by severity The full interaction hub: 5 major · 116 moderate · 44 minor · every one linked to its full report. Check Oxybutynin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Oxybutynin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Oxybutynin — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is oxybutynin supposed to do for me?

▾
Oxybutynin calms down an overactive bladder by relaxing the bladder muscle and reducing those sudden, hard-to-ignore urges to go. Over time, most people find they have fewer urgent trips to the bathroom, less leaking, and they're not constantly watching for the nearest restroom. It doesn't cure the underlying condition, but it makes day-to-day life a lot more manageable.

My mouth is incredibly dry since starting this — is that normal?

▾
Yes, dry mouth is the most common side effect of oxybutynin — and it's more noticeable with the immediate-release tablets than the extended-release form. Sipping water throughout the day, chewing sugar-free gum, or using a saliva substitute can help. If it's really bothering you, don't just stop the medication — talk to your prescriber, because adjusting your dose or switching formulations might make a difference.

I take the extended-release tablet — can I split it in half if it's hard to swallow?

▾
No — extended-release tablets must be swallowed whole with a glass of liquid. Cutting, crushing, or chewing them breaks the controlled-release mechanism and can release too much medication at once. If swallowing is a problem, let your doctor know — there are liquid and patch forms that might work better for you.

What side effects should actually make me call a doctor right away?

▾
A few things are worth acting on quickly. If you notice swelling of your face, lips, tongue, or throat — even mild — stop the medication and get emergency help, since this can affect your airway. Also call your doctor if you start having hallucinations, severe confusion, can't urinate at all, or notice a fast or pounding heartbeat. Drowsiness and dizziness are common but shouldn't get to the point where you're unsafe to function.

Are there any other medications I should be careful about taking with this?

▾
Yes — a few worth knowing about. Other medications with anticholinergic effects (many allergy, sleep, or bladder drugs fall into this group) can pile on with oxybutynin and make side effects like dry mouth and confusion much worse. Certain antifungals and antibiotics — like ketoconazole, erythromycin, or clarithromycin — can raise oxybutynin levels in your blood. Always show your pharmacist or doctor your full medication list before starting oxybutynin.

Can I use this patch if I'm pregnant or breastfeeding?

▾
There isn't enough safety data yet to know whether oxybutynin is safe during pregnancy or while breastfeeding. It's also not known whether the drug passes into breast milk. That doesn't mean it's definitely a problem, but it does mean you should have an honest conversation with your doctor about the risks and benefits before using it in either situation.

Is Oxybutynin available over the counter?

▾
Both. Some Oxybutynin products are sold over the counter and others need a prescription. According to their FDA listings, the skin patch form is sold both ways, at different strengths or package sizes and the extended-release tablet, tablet and oral solution forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Oxybutynin first available?

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The earliest FDA record we hold for Oxybutynin is from 1975: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Oxybutynin was first used.

Who makes Oxybutynin?

▾
40 companies currently list Oxybutynin products in the FDA's NDC Directory, including A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC, Bryant Ranch Prepack. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Oxybutynin on HelloPharmacist

📊Oxybutynin supplement interactions165 checked — ranked by severity 🌿Drug & Supplement CheckerOxybutynin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Oxybutynin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Oxybutynin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Oxybutynin forms and strengths (how it comes)

Oxybutynin is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Oxybutynin Chloride
How this form is used
What it may be used for
  • Oxybutynin Chloride extended-release tablets treat overactive bladder with urge incontinence, urgency, and frequent urination in adults
  • Oxybutynin Chloride extended-release tablets are also approved for children 6 years and older with bladder overactivity due to a neurological condition such as spina bifida
Important instructions
  • Oxybutynin Chloride extended-release tablets must be swallowed whole with liquid — do not chew, crush, or divide them
  • Oxybutynin Chloride extended-release tablets can be taken with or without food
  • Oxybutynin Chloride extended-release tablets are taken once daily at approximately the same time each day
  • Oxybutynin Chloride extended-release tablets are not recommended for children who cannot swallow the tablet whole
Available strengths 3 strengths
5 mg 10 mg 15 mg
134 FDA-listed product records ⓘ

Tablet

By mouth
Brands Oxybutynin Chloride
How this form is used
What it may be used for
  • Oxybutynin Chloride tablets relieve symptoms of bladder instability — including urgency, frequency, urinary leakage, urge incontinence, and painful urination — in patients with neurogenic bladder
Important instructions
  • Oxybutynin Chloride tablets are taken multiple times daily — adults typically take them two to three times a day
  • Oxybutynin Chloride tablets may be given to children over 5 years of age, typically twice daily, as directed by a prescriber
  • A lower starting dose of Oxybutynin Chloride tablets is recommended for frail elderly patients — follow your prescriber's guidance
Available strengths 2 strengths
2.5 mg 5 mg
92 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Oxybutynin Chloride
How this form is used
What it may be used for
  • Oxybutynin Chloride oral solution relieves symptoms of bladder instability — including urgency, frequency, urinary leakage, urge incontinence, and painful urination — in patients with neurogenic bladder
Important instructions
  • Oxybutynin Chloride oral solution is taken multiple times a day — adults typically take it two to three times daily
  • Oxybutynin Chloride oral solution may be taken at a lower frequency in children over 5 years of age, as directed by a prescriber
  • Follow your prescriber's instructions for exact dosing schedule and timing
Available strengths 1 strength
5 mg/5 mL
7 FDA-listed product records ⓘ

Skin patch

Through the skin
Brands Oxytrol Oxytrol for Women
How this form is used
What it may be used for
  • Oxytrol is approved to treat overactive bladder in men with urge incontinence, urgency, and frequent urination
  • Oxytrol for Women is approved to treat overactive bladder in women 18 years and older with urinary frequency, urgency, and urge incontinence
Important instructions
  • Oxytrol should be applied to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 to 4 days) and should not be cut or divided
  • Oxytrol for Women should be applied to a clean, dry, smooth area on the abdomen, hips, or buttocks; change it every 4 days
  • Rotate the application site with each new patch — do not reapply Oxytrol to the same spot within 7 days
  • Do not apply either patch to oily, damaged, or irritated skin, or skin with lotions or powders; keep the patch out of direct sunlight
Available strengths 2 strengths
3.9 mg/d OXYBUTYNIN 3.9 mg/d
6 FDA-listed product records ⓘ

Oxybutynin on the U.S. market: products, makers and brands

How Oxybutynin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

40 companies list 117 Oxybutynin product records with the FDA, mostly as extended-release tablet, tablet, oral solution; the earliest marketing or approval year on record is 1975. Brand names on the directory include Ditropan XL, Ditropan, Oxytrol and 4 more; the rest are generics.

4
Dose forms ⓘ
40
Labelers (makers, repackagers, distributors)
5
Brand names
117
FDA-listed product records ⓘ
1975
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions10%
Aphena Pharma Solutions - Tennessee, LLC7%
Bryant Ranch Prepack6%
PD-Rx Pharmaceuticals, Inc.6%
Rising Pharma Holdings, Inc.6%
AvKARE3%
Other makers62%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Oxybutynin is used (Medicaid data)

A general measure of how commonly Oxybutynin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Oxybutynin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

974,653
Medicaid prescriptions filled (Q1–Q4 2025)
$12.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxybutynin prescribed? Of the 1,601 medications we measure, Oxybutynin ranks #180 by Medicaid prescriptions — more than 89% of them.

Where Oxybutynin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #180 of 1,601
#175 Ethinyl Estradiol / Fe... 1,010,948 Rx #176 Clotrimazole Topical 1,007,055 Rx #177 Insulin Aspart (rDNA O... 1,003,363 Rx #178 Lisinopril and Hydroch... 999,534 Rx #179 Naloxone 980,072 Rx #180 Oxybutynin 974,653 Rx #181 Naloxone Nasal Spray 970,105 Rx #182 Budesonide 967,284 Rx #183 Ciprofloxacin 959,810 Rx #184 Erythromycin 942,102 Rx #185 Linaclotide 914,996 Rx

Utilization by Oxybutynin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg oral tablet is the most-dispensed Oxybutynin product — about 35% of these Medicaid prescriptions.

oxybutynin chloride 5 MG Oral Tablet Most dispensed

343,853 Medicaid prescriptions (Q1–Q4 2025) 35% of Oxybutynin prescriptions shown $3.8M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 27 of 169 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863664

24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet

286,195 Medicaid prescriptions (Q1–Q4 2025) 29% of Oxybutynin prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 13 of 82 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863619

24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet

207,585 Medicaid prescriptions (Q1–Q4 2025) 21% of Oxybutynin prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 14 of 73 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863636

24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet

102,386 Medicaid prescriptions (Q1–Q4 2025) 11% of Oxybutynin prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 8 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863628

oxybutynin chloride 1 MG/ML Oral Solution

30,581 Medicaid prescriptions (Q1–Q4 2025) 3% of Oxybutynin prescriptions shown $481,388 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863599

oxybutynin chloride 2.5 MG Oral Tablet

3,251 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxybutynin prescriptions shown $403,707 gross reimbursement (before rebates) ≈ $124 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863758

84 HR oxybutynin 0.162 MG/HR Transdermal System

802 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxybutynin prescriptions shown $409,269 gross reimbursement (before rebates) ≈ $510 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 403799

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Oxybutynin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 67 of 392 listed Oxybutynin NDCs with Medicaid activity.

Compare Oxybutynin products

A representative set of FDA-listed product records for Oxybutynin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 99 of 117 products — FDA National Drug Code Directory. See every product, package size and price: browse all 117 Oxybutynin NDCs →

Oxybutynin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Oxybutynin recalls since July 2021, covering 4 product listings. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Oct 19, 2023 · Completed · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
  • Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-… Lots: M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024 FDA record D-0098-2024 →
  • Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-2… Lots: M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024 FDA record D-0097-2024 →
  • Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-2… Lots: M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024 FDA record D-0096-2024 →
Class II Sep 21, 2023 · Terminated · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications
  • Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, I… Lots: Lot#: M300652 and M300651, exp. Dec 2024 FDA record D-0038-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Oxybutynin RxCUI 32675 5 dose forms · 10 strengths
  2. Dose form (SCDF) Oral Solution RxCUI 380857 In current FDA listings
    Clinical drug / strength (SCD) chloride 0.5 MG/ML RxCUI 863654 chloride 1 MG/ML RxCUI 863599
  3. Dose form (SCDF) Oral Tablet RxCUI 373193 In current FDA listings
    Clinical drug / strength (SCD) chloride 2.5 MG RxCUI 863758 chloride 3 MG RxCUI 863799 chloride 5 MG RxCUI 863664
  4. Dose form (SCDF) Topical Gel RxCUI 831885 No current FDA listing
    Clinical drug / strength (SCD) chloride 0.1 MG/MG RxCUI 864818
  5. Dose form (SCDF) Transdermal System RxCUI 1805970 In current FDA listings
    Clinical drug / strength (SCD) 84 HR oxybutynin 0.162 MG/HR RxCUI 403799

Look up RxCUI 32675 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Oxybutynin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Extended Release · Oral 10 mg $0.103 per tablet NDC details & price history
Tablet, Extended Release · Oral 5 mg $0.084 per tablet NDC details & price history
Tablet, Extended Release · Oral 15 mg $0.117 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 15 mg $0.125 per tablet NDC details & price history
Patch · Transdermal 3.9 mg/d $81.29 each NDC details & price history
Patch · Transdermal OXYBUTYNIN 3.9 mg/d $81.29 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Oxybutynin brand names

Oxybutynin is sold under 7 brand names in the FDA directory — Ditropan XL, Ditropan, Oxytrol, Gelnique and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ditropan XL Ditropan Oxytrol Gelnique Oxybutynin Chloride Oxybutynin Chloride Extended Release Oxytrol for Women

Who makes Oxybutynin: manufacturers and labelers

40 companies list Oxybutynin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC, Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 12 Aphena Pharma Solutions - Tennessee, LLC 8 Bryant Ranch Prepack 7 PD-Rx Pharmaceuticals, Inc. 7 Rising Pharma Holdings, Inc. 7 AvKARE 4 Chartwell RX, LLC 4 Lannett Company, Inc. 4 Accord Healthcare, Inc. 3 Advagen Pharma Limited 3 Ajanta Pharma USA Inc. 3 American Health Packaging 3 Amneal Pharmaceuticals LLC 3 AvPAK 3 Coupler LLC 3 NCS HealthCare of KY, LLC dba Vangard Labs 3 Proficient Rx LP 3 Strides Pharma Science Limited 3 Zydus Lifesciences Limited 3 Zydus Pharmaceuticals USA Inc. 3 direct rx 3 Allergan, Inc. 2 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2 Major Pharmaceuticals 2

…and 16 more on the FDA NDC directory.

Oxybutynin drug class (RxNorm)

Oxybutynin belongs to the Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Oxybutynin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 7, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxybutynin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Oxybutynin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
86
Finished products in the current FDA directory
117
Companies listing them (makers, repackagers, distributors)
40
FDA labeler codes behind them ⓘ
48
Linked representative label ⓘ
Zydus Pharmaceuticals USA Inc.
Linked label effective
Nov 7, 2023
Composite sections available
23
Linked SPL Set ID
c042bf06-79a3-4dc7-ae05-3ef3cfae9d44
Linked SPL Document ID
f54e4d4e-91be-4e10-a446-57ed5e1843a1
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Zydus Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →