Flavoxate Hydrochloride is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Taken
- Oral
- Label
- PuraCap Laboratories LLC dba Blu Pharmaceuticals, revised December 11, 2025 · full label on DailyMed
- Generic
- FDA-approved (2 companies) · details
What it is used for
Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
Who should not take it (contraindications)
Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.
Warnings
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
Precautions
Information for Patients Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required. Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed. Pregnancy Teratogenic Effects-Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate hydrochloride is administered to a nursing woman. Pediatric Use Safety and effectiveness in children below the age of 12 years have not been established.
Side effects (adverse reactions)
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic : Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.
Pregnancy
Teratogenic Effects-Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Breastfeeding
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate hydrochloride is administered to a nursing woman.
Use in children
Safety and effectiveness in children below the age of 12 years have not been established.
Is there a generic Flavoxate Hydrochloride?
Yes. The FDA has approved generic Flavoxate Hydrochloride from 2 companies whose approvals are active. The earliest of these was approved in 2004.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Epic Pharma, Padagis Us
Brand-name versions
- Urispas Ortho Mcneil Janssen, approved 1970 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Flavoxate in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88.