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.
How to Take It
Take this medicine once a day, around the same time each day. Swallow the tablet whole with a drink. Do not chew, crush, or divide the tablet. You can take it with or without food.
This is a plain-language summary of oxybutynin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Talk to your doctor if you are breastfeeding.
This is a plain-language summary of oxybutynin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of oxybutynin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (between 59°F and 86°F). Protect from moisture and humidity.
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
- Feeling tired
Feeling tired
1,539 reports
- Falling down
Falling down
1,466 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,211 reports
- Feeling unsteady or lightheaded
Feeling unsteady or lightheaded
1,143 reports
- Loose, watery stools
Loose, watery stools
1,078 reports
- Aches or soreness
Aches or soreness
1,077 reports
- Bladder infection
Bladder infection
1,041 reports
- Pain in your head
Pain in your head
991 reports
- Itching
Itching
968 reports
- Redness where medicine was applied
Redness where medicine was applied
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) 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.
What to do: Your doctor may need to lower your dose of oxybutynin and monitor you closely for side effects.
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.
What to do: Your doctor may need to adjust your dose or monitor you more closely for side effects.
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.
What to do: Tell your healthcare provider if you notice increased side effects, as they may need to change your dosage.
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.
What to do: Your doctor should monitor your response to the medication and may adjust your dose if needed.
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.
What to do: Your doctor may need to check if both medications are still working effectively for you.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is oxybutynin safe during pregnancy?
Is oxybutynin currently in shortage?
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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: May 31, 2023
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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