Prescription medication · Anticholinergic / Antispasmodic

oxybutynin

Also sold as Ditropan. This medicine treats overactive bladder.

Data updated 2026-05-15

28,434
FDA reportsModerately reported
7
InteractionsFew interactions
In shortage
FDA status

What the data shows

oxybutynin (Ditropan) is a prescription Anticholinergic / Antispasmodic, reported at a middle-of-the-pack volume (28,434 FDA reports), with 7 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

oxybutynin (Ditropan) is a prescription Anticholinergic / Antispasmodic. This medicine treats overactive bladder.

Oxybutynin extended-release tablets help control an overactive bladder. It reduces the feeling of needing to go to the bathroom often.

Drug Shortage Alert

oxybutynin is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC.

View all drug shortages →

Drug Pricing (NADAC)

Generic Price

$1.95/unit

Generic Available

Yes (17 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

This medicine treats overactive bladder.

Common side effects

Dry mouth, Constipation, Diarrhea

Key warnings

Oxybutynin can cause swelling of the face, lips, tongue, and throat (angioedema).

The sections below are summarized in plain English from oxybutynin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Oxybutynin belongs to a class of drugs called antimuscarinics. It works by relaxing the bladder muscles. This helps to decrease the urge to urinate and prevent leakage.

Side Effects (from patient reports)

Based on 28,434 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for oxybutynin, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for oxybutynin each year to the FDA Adverse Event Reporting System (FAERS).

02,0004,0006,000 200320062009201220152018202120242025 1,184

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where oxybutynin sits

oxybutynin has more FDA adverse-event reports than 62% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is oxybutynin; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 28,434 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

28,434

Reports Mentioning Death

1,650

5.8% of reports — not proof of cause

Hospitalization Reports

6,729

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 20,928 (77%)
Male 5,943 (22%)

Age Distribution

0–17 375
18–44 1,542
45–64 5,978
65–74 4,270
75+ 4,596

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 FATIGUE 1,539
3 FALL 1,467
5 NAUSEA 1,211
6 DIZZINESS 1,144
7 DIARRHOEA 1,079
8 PAIN 1,077
9 URINARY TRACT INFECTION 1,043
10 HEADACHE 991
11 PRURITUS 968
12 APPLICATION SITE ERYTHEMA 913
13 ASTHENIA 888
14 RASH 808
15 PRODUCT ADHESION ISSUE 775
16 DYSPNOEA 751
17 CONSTIPATION 721

Reactions in Death Reports

DEATH 680
COMPLETED SUICIDE 193
TOXICITY TO VARIOUS AGENTS 89
PNEUMONIA 73
CARDIAC ARREST 69
FALL 64
RENAL FAILURE 63
RESPIRATORY FAILURE 63
MYOCARDIAL INFARCTION 59
DYSPNOEA 57

Reactions in Hospitalization Reports

FALL 746
URINARY TRACT INFECTION 600
PNEUMONIA 451
ASTHENIA 426
NAUSEA 395
FATIGUE 394
PAIN 391
DIARRHOEA 353
DYSPNOEA 342
VOMITING 336

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Oxybutynin can cause swelling of the face, lips, tongue, and throat (angioedema). If this happens, stop taking the medicine right away and get medical help. This medicine can also cause confusion, hallucinations, and drowsiness. Be careful driving or operating machinery until you know how it affects you. Use caution if you have dementia, Parkinson's disease, myasthenia gravis, or decreased gut motility.

Known Drug Interactions

Mean oxybutynin chloride plasma concentrations were approximately 2 fold higher when Oxybutynin chloride extended-release tablets were administered with ketoconazole, a potent CYP3A4 inhibitor. (7) Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole) increases the systemic exposure of oxybutynin.

Mechanism: Ketoconazole blocks the enzyme that breaks down oxybutynin, which can cause the amount of oxybutynin in your body to double.

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).

Mechanism: Erythromycin slows down the process your body uses to get rid of oxybutynin. This can cause the level of oxybutynin in your blood to rise higher than normal.

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).

Mechanism: Clarithromycin blocks the natural enzymes that break down oxybutynin in your system. This leads to more of the drug staying in your body for a longer time.

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).

Mechanism: Itraconazole interferes with how your body processes oxybutynin. This can increase the amount of oxybutynin in your bloodstream.

Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide.

Mechanism: These two drugs have opposite effects on how your digestive system moves. Oxybutynin can block metoclopramide from doing its job of moving food through your stomach.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I cut the tablet in half?
No, you must swallow the tablet whole. Do not chew, crush, or divide it.
Can I take this medicine with food?
Yes, you can take it with or without food.
What should I do if I feel dizzy?
Be careful when driving or operating machinery. If dizziness continues, talk to your doctor.
How long does it take for this medicine to work?
It may take a few weeks to see the full effects of this medicine.
Can I drink alcohol while taking this medicine?
Alcohol can increase drowsiness. Talk to your doctor about drinking alcohol while taking this medicine.
What if I have glaucoma?
You should not take this medicine if you have uncontrolled narrow-angle glaucoma.
Can this medicine cause dry eyes?
Yes, dry eyes are a possible side effect.
What do I do if I get a rash?
Stop taking the medicine and contact your doctor right away.
Can I take this with other medicines?
Tell your doctor about all the medicines you take, including over-the-counter drugs and supplements.
What if I can't swallow pills?
This medicine is not recommended for children who cannot swallow the tablet whole.
What are the common side effects of oxybutynin?
The registry lists Dry mouth, Constipation, Diarrhea, Headache, Feeling sleepy among the most-reported FAERS reaction terms for oxybutynin. The compiled record contains 28,434 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does oxybutynin interact with other medications?
The registry has 7 documented interaction rows for oxybutynin. Notable source-record pairings include ketoconazole, erythromycin, clarithromycin. These rows are not a complete medication review.
What drug class is oxybutynin?
oxybutynin belongs to the Anticholinergic / Antispasmodic drug class. It requires a prescription (Rx). This medicine treats overactive bladder.
What pregnancy or breastfeeding source fields are listed for oxybutynin?
The FDA label for oxybutynin contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Is oxybutynin currently in shortage?
Yes, oxybutynin is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC. Visit the FDA Drug Shortages database for the latest updates.

Other drugs grouped near oxybutynin - same-class peers and common alternatives.

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Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for oxybutynin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

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What the FDA Data Shows for oxybutynin

The FDA label for oxybutynin (sold under brand names such as Ditropan) classifies it as a prescription-only medication in the Anticholinergic / Antispasmodic class. This medicine treats overactive bladder. Official labeling lists 6 commonly reported side effects, including Dry mouth, Constipation, Diarrhea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 28,434 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $1.95.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: May 31, 2023

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page