Flavoxate
Flavoxate is a urinary tract antispasmodic used to relieve symptoms such as painful urination, urgency, frequency, and incontinence caused by bladder and urinary tract conditions.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Flavoxate (Urispas) is an older urinary antispasmodic that relaxes the bladder's smooth muscle to ease burning, urgency, frequency and night-time trips from bladder, prostate or urethra irritation; it has been around since about 1970, is available as a generic, and is now a less common choice. Most people tolerate it reasonably well, and dry mouth, drowsiness and mild blurred vision are what they notice most. The thing to watch for is confusion in older adults, or new eye pain if you have glaucoma, and either is a reason to call your prescriber. It only eases symptoms, so it works alongside, never instead of, the antibiotic that clears an infection.
Clinical pearls
- It is not for anyone with a stomach, bowel or lower urinary tract blockage, achalasia (a swallowing disorder) or gastrointestinal bleeding.
- Drowsiness, dizziness and blurred vision can follow a dose, so see how it affects you before driving.
- If painful urination starts or worsens while taking it, the underlying problem needs rechecking, since flavoxate should be easing it.
- It is not recommended for children under 12, so never share an adult's supply with a child.
Patient information guide A plain-language walkthrough of Flavoxate, written from its FDA label.
What Flavoxate is used for
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Flavoxate is used to relieve uncomfortable urinary symptoms caused by inflammation or infection of the urinary tract. It treats symptoms — not the underlying infection itself — and is meant to be used alongside antibiotics or other appropriate treatments.
- Painful or burning urination (dysuria)
- Sudden, strong urge to urinate (urgency)
- Needing to urinate more often than normal (frequency)
- Waking up at night to urinate (nocturia)
- Lower abdominal or pelvic pain (suprapubic pain)
- Bladder leakage (incontinence)
- These symptoms may be caused by cystitis, prostatitis, urethritis, urethrocystitis, or urethrotrigonitis
How Flavoxate works
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Flavoxate works by directly relaxing the smooth muscle in the walls of the urinary tract. When the urinary tract is irritated or infected, the muscles can go into spasm — causing that urgent, frequent, painful need to urinate. Flavoxate calms those spasms, easing the discomfort. It does not fight bacteria or treat infection; it simply helps the muscle relax while other treatments address the root cause.
Flavoxate dosage
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Flavoxate Hydrochloride is taken as an oral tablet, several times throughout the day. It is approved for adults and children over 12 years of age; it is not recommended for children 12 and under. Your doctor may lower your dose as your symptoms improve.
- Taken by mouth, typically three or four times daily
- Dose may be reduced with symptom improvement — follow your prescriber's guidance
- Not recommended for children under 12 (safety and effectiveness not established)
Dosing details from the FDA-approved label
From the Flavoxate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and children over 12 years of age
- One or two 100 mg tablets 3 or 4 times a day
- With improvement of symptoms, the dose may be reduced
- Infants and children under 12 years of age
- This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group
- Not recommended under 12 years of age
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.
Read the full Dosage and Administration section on DailyMed →
Flavoxate side effects
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Like any medication, flavoxate can cause side effects. The most commonly reported ones include:
Common side effects
- Dry mouth
- Nausea or vomiting
- Dizziness or vertigo
- Headache
- Drowsiness
- Blurred vision
- Rapid heartbeat or palpitations
- Nervousness
- Blurred vision or difficulty focusing
When to get medical help
- Call your doctor if you develop confusion or unusual mental changes, especially if you are elderly
- Seek medical attention for any signs of an allergic reaction, such as skin rash, hives, or fever
- Tell your doctor right away if you notice increased eye pressure or worsening eye pain — especially if you have glaucoma
- Contact your doctor if you experience painful urination (dysuria) that develops or worsens while on this medication
More serious reactions — including mental confusion (especially in older adults), skin rash or hives, fever, increased eye pressure, or a drop in white blood cells (leukopenia) — have been reported and should prompt a call to your doctor right away.
Flavoxate warnings and precautions
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- Glaucoma: Flavoxate may increase pressure inside the eye. Anyone with glaucoma or suspected glaucoma should use this medication with caution and under close medical supervision.
- Blocked passages: Do not take flavoxate if you have any obstruction in your stomach, intestines, or lower urinary tract, or conditions like achalasia, ileus, or gastrointestinal bleeding — these are absolute contraindications.
- Older adults: Mental confusion has been reported, particularly in elderly patients. Caregivers should watch for this.
- Children under 12: Safety and effectiveness have not been established — this medication is not recommended for this age group.
Flavoxate interactions
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The FDA label for flavoxate does not specifically list drug, food, or supplement interactions. Always tell your doctor and pharmacist about every medication and supplement you take before starting flavoxate.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Flavoxate
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- Tell your doctor if you have glaucoma or are being evaluated for eye pressure problems
- Do not take this medication if you have a blockage in your stomach or intestines, bowel obstruction, ileus, achalasia, gastrointestinal bleeding, or a blockage in your lower urinary tract
- Older adults should use with caution — confusion is a reported side effect in this group
- Not for use in children under 12 years of age
- Let your doctor know all other medications you are taking before starting flavoxate
Flavoxate overdose
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The FDA label does not describe specific overdose symptoms for flavoxate in people. Animal studies used to estimate lethal doses are included in the label but do not directly translate to human experience. If you think you or someone else has taken too much flavoxate, contact Poison Control or seek emergency medical care immediately. It is not known whether dialysis can remove flavoxate from the body.
What Flavoxate does in the body
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Flavoxate directly relaxes smooth muscle in the urinary tract, reducing spasms that cause urgency, pain, and frequent urination. In a study of healthy adult men, the medication began to take effect in about 55 minutes, with peak effects measured at around 112 minutes after a dose. These effects help ease the discomfort of urinary tract inflammation without treating the infection causing it.
How your body processes Flavoxate
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After an oral dose, flavoxate is absorbed and begins working within about an hour. About 57% of the drug is eliminated through the urine within 24 hours, indicating the kidneys play a key role in clearing the medication from the body.
How to store Flavoxate
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Store at 20° - 25°C (68° - 77°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Flavoxate
17 supplements and herbal products have documented interactions with Flavoxate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Flavoxate: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Flavoxate — the kind of thing our pharmacy team would talk through with you at the counter.
Will flavoxate actually cure my bladder infection?
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How long does it take for flavoxate to start working?
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What side effects should I actually watch out for?
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I have glaucoma — is it safe for me to take flavoxate?
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Can I give flavoxate to my child?
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Are there any medications or conditions that mean I absolutely cannot take flavoxate?
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Is Flavoxate available over the counter?
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When was Flavoxate first available?
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Who makes Flavoxate?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Flavoxate on HelloPharmacist
Flavoxate forms and strengths (how it comes)
Flavoxate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Flavoxate inactive ingredients by manufacturer.
Tablet
How this form is used
- Flavoxate Hydrochloride tablets relieve urinary symptoms such as painful urination, urgency, frequency, and incontinence
- Flavoxate Hydrochloride tablets are used alongside treatments for cystitis, prostatitis, urethritis, and related urinary tract conditions
- Flavoxate Hydrochloride tablets are for symptom relief only — not for treating the underlying infection
- Flavoxate Hydrochloride tablets are taken by mouth three or four times a day for adults and children over 12
- Flavoxate Hydrochloride tablets may be taken at a lower frequency once symptoms begin to improve, as directed by your doctor
- Flavoxate Hydrochloride tablets are not recommended for children under 12 years of age
Flavoxate on the U.S. market: products, makers and brands
How Flavoxate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 3 Flavoxate product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1970. Brand names on the directory include Urispas; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Flavoxate is used (Medicaid data)
A general measure of how commonly Flavoxate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Flavoxate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Flavoxate prescribed? Of the 1,601 medications we measure, Flavoxate ranks #1,407 by Medicaid prescriptions — more than 12% of them.
Utilization by Flavoxate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
flavoxate hydrochloride 100 MG Oral Tablet
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1095229
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Flavoxate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 5 listed Flavoxate NDCs with Medicaid activity.
Compare Flavoxate products
A representative set of FDA-listed product records for Flavoxate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 100 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 100 mg | Oral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | ANDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Flavoxate NDCs →
Flavoxate side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Flavoxate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Flavoxate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Flavoxate FDA approval history
How Flavoxate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Flavoxate recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Flavoxate recalls since July 2021.
✅No Flavoxate recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4440 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 372200In current FDA listingsClinical drug / strength (SCD) hydrochloride 100 MGRxCUI 1095229hydrochloride 200 MGRxCUI 1095234
Look up RxCUI 4440 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Flavoxate supply and shortage status
Whether Flavoxate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Flavoxate costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 100 mg | $0.547 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 100 mg | $0.389 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Flavoxate brand names
Flavoxate is sold under one brand name in the FDA directory — Urispas. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Flavoxate: manufacturers and labelers
3 companies list Flavoxate products with the FDA. By number of product records, the largest are Epic Pharma, LLC, Padagis US LLC, PuraCap Laboratories LLC dba Blu Pharmaceuticals. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Flavoxate drug class (RxNorm)
Flavoxate belongs to the Cholinergic Muscarinic Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Flavoxate page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Padagis US LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →