oxybutynin chloride
Pharmaranks rates Oxybutynin Chloride 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Oxybutynin Chloride is a cholinergic muscarinic antagonist used to treat Neurogenic Urinary Bladder, Urinary Incontinence, Dysuria.
Cholinergic Muscarinic Antagonist · by Leading
Generic of Gelnique
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Oxybutynin Chloride
- Drug class
- Cholinergic Muscarinic Antagonist
- Form
- Solution, Syrup, Tablet, Tablet, extended release
- Strength
- Oxybutynin Chloride 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Leading
- Half-life
- about 2 to 3 hours (how long it stays in your system)
- FDA application
- ANDA212798
What is Oxybutynin Chloride?
From the FDA label:Each scored round, uncoated, oxybutynin chloride tablet contains 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is 4(diethylamino-but-2-ynyl (RS) 2-cyclohexyl-2-hydroxy 2 phenyl acetate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. The structural formula appears below: Oxybutynin Chloride is a white crystalline, practically odorless powder with a molecular weight of 393.95. It is freely soluble in water and in alcohol; very soluble in methanol and in chloroform; soluble in acetone; slightly soluble in ether; very slightly soluble in hexane. Oxybutynin Chloride Tablets, USP also contain magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Oxybutynin Chloride Tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. FDA approved dissolution test specifications differ from USP. Chem Structure
How to use
Oxybutynin Chloride is sold in more than one form (Solution, Syrup, Tablet and Tablet, extended release), and each is dosed differently. The instructions below come from the FDA label for application ANDA212798 — follow the label that came with the product you were actually prescribed.
Adults: The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric patients over 5 years of age: The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.
Side effects
The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5-20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients. Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin Chloride (5-20 mg/day) Body System Adverse Event Oxybutynin Chloride (5-20 mg/day) (n=199) Infections and Infestations Urinary tract infection 6.5% Psychiatric Disorders Insomnia Nervousness 5.5% 6.5% Nervous System Disorders Dizziness Somnolence Headache 16.6% 14.0% 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth Constipation Nausea Dyspepsia 71.4% 15.1% 11.6% 6.0% Renal and Urinary Disorders Urinary Hesitation Urinary Retention 8.5% 6.0% The most common adverse events reported by patients receiving oxybutynin chloride 5-20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1 to <5% of patients using oxybutynin chloride (5-20 mg/day) in all studies. Infections and Infestations : nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition…
Warnings
Important safety information
Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
Who should not take Oxybutynin Chloride
Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
Overdose — what happens if you take too much
Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 3-4 fold higher when oxybutynin chloride 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.
How long does Oxybutynin Chloride stay in your body?
The elimination half-life of oxybutynin chloride is about 2 to 3 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the immediate-release oral figure: the label states oxybutynin is rapidly absorbed, reaching peak levels within an hour, after which plasma levels fall with an effective half-life of about 2 to 3 hours. The same label notes that in the frail elderly the elimination half-life is prolonged to about 5 hours and a lower starting dose is recommended — the group most often prescribed this drug clears it more slowly. Extended-release tablets do not clear faster or slower: the apparent half-life after a single 10 mg ER dose is about 12 to 13 hours, which reflects slow release, not slower elimination. The active metabolite N-desethyloxybutynin outlasts the parent and reaches far higher levels after a swallowed dose (metabolite-to-parent AUC ratio 11.9 to 1 after a single 5 mg oral dose, versus 1.3 to 1 with the transdermal patch, which skips first-pass metabolism). Oxybutynin is cleared almost entirely by liver CYP3A4 (under 0.1% of the dose leaves unchanged in urine), so CYP3A4 inhibitors can raise exposure. No studies were conducted in kidney or liver impairment.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Oxybutynin Chloride Tablets USP — FDA prescribing information, Clinical Pharmacology (DailyMed).
Drug class
How this class works, per Muscarinic Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Oxybutynin Chloride ranks — best-rated cholinergic muscarinic antagonist for:
Dosage forms
Solution, Syrup, Tablet and Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Oxybutynin Chloride treat?
- Oxybutynin Chloride (Oxybutynin Chloride) may be used to treat neurogenic urinary bladder, urinary incontinence, dysuria, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Oxybutynin Chloride work?
- Oxybutynin Chloride is a cholinergic muscarinic antagonist. These drugs block muscarinic receptors, the docking sites for the nerve signal acetylcholine. By preventing acetylcholine from acting, they calm the 'rest-and-digest' nervous system, which can dry secretions, relax airway and bladder muscles, and speed up the heart, depending on the drug.
- How is Oxybutynin Chloride rated?
- pharmaranks gives Oxybutynin Chloride a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Oxybutynin Chloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Oxybutynin Chloride. To pay less, Oxybutynin Chloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Oxybutynin Chloride?
- Oxybutynin Chloride is marketed by Leading. You can see Leading's full profile, rating, and other products on pharmaranks.
- Is Oxybutynin Chloride a brand-name or generic drug?
- Oxybutynin Chloride is a generic medication; its active ingredient is Oxybutynin Chloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Oxybutynin Chloride available over the counter?
- No. Oxybutynin Chloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Oxybutynin Chloride come in?
- Oxybutynin Chloride is currently marketed as solution, syrup, tablet and tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Oxybutynin Chloride?
- Oxybutynin Chloride is classified as cholinergic muscarinic antagonist, per the FDA's Established Pharmacologic Class.
- Is Oxybutynin Chloride FDA-registered?
- Oxybutynin Chloride is on record with the U.S. FDA under application number ANDA212798. You can verify this on its official FDA label.
- Has Oxybutynin Chloride been recalled by the FDA?
- Oxybutynin Chloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Oxybutynin Chloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Oxybutynin Chloride a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Oxybutynin Chloride?
- Oxybutynin Chloride's side effects are taken directly from its FDA label. From the label: The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5-20 mg/day for up to 6 weeks.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
Compare Oxybutynin Chloride head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
oxybutynin chloride
70/100