oxybutynin
Brand names: Ditropan
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 →
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).
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.
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.
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.
Storage
Store at room temperature (between 59°F and 86°F). Protect from moisture and humidity.
Side Effects (from patient reports)
Based on 14,711 FDA adverse event reports.
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
Death-Related Reports
1,650
Hospitalization Reports
6,729
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 3,925 |
| 2 | FATIGUE | 1,539 |
| 3 | FALL | 1,467 |
| 4 | OFF LABEL USE | 1,240 |
| 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 |
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.
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?
Related Medications in Anticholinergic / Antispasmodic
Other drugs grouped near oxybutynin — same-class peers and common alternatives.
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dutasteride/tamsulosin
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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
Related Health & Safety Data
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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 14,711 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.
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