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.
Verify with FDA → · CMS NADAC pricing →
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 →
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
- Fatigue
Fatigue
1,539 reports
- Fall
Fall
1,467 reports
- Nausea
Nausea
1,211 reports
- Dizziness
Dizziness
1,144 reports
- Diarrhoea
Diarrhoea
1,079 reports
- Pain
Pain
1,077 reports
- Urinary Tract Infection
Urinary Tract Infection
1,043 reports
- Headache
Headache
991 reports
- Pruritus
Pruritus
968 reports
- Application Site Erythema
Application Site Erythema
913 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.
Reports over time
Adverse-event reports filed for oxybutynin each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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.
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?
Can I take this medicine with food?
What should I do if I feel dizzy?
How long does it take for this medicine to work?
Can I drink alcohol while taking this medicine?
What if I have glaucoma?
Can this medicine cause dry eyes?
What do I do if I get a rash?
Can I take this with other medicines?
What if I can't swallow pills?
What are the common side effects of oxybutynin?
Does oxybutynin interact with other medications?
What drug class is oxybutynin?
What pregnancy or breastfeeding source fields are listed for oxybutynin?
Is oxybutynin currently in shortage?
Related Medications in Anticholinergic / Antispasmodic
Other drugs grouped near oxybutynin - same-class peers and common alternatives.
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darifenacin
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dutasteride
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dutasteride/tamsulosin
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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.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 28,434.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.80%.
- selenium Δ 0.02 pts · 4,079 reports · Mineral Supplement 5.79%death share
- ezetimibe Δ 0.04 pts · 70,203 reports · Cholesterol Absorption Inhibitor 5.84%death share
- rufinamide Δ 0.07 pts · 2,477 reports · Anticonvulsant (Triazole) 5.73%death share
- potassium citrate Δ 0.08 pts · 5,207 reports · Urinary Alkalinizer 5.72%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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.
Read our methodology - how this data is sourced, computed, and verified.
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
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages