FLAVOXATE: 63 Adverse Event Reports & Safety Profile
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Active Ingredient: FLAVOXATE HYDROCHLORIDE · Drug Class: Cholinergic Muscarinic Antagonist [EPC] · Route: ORAL · Manufacturer: Padagis US LLC · FDA Application: 016769 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20050224 · Latest Report: 20240920
What Are the Most Common FLAVOXATE Side Effects?
All FLAVOXATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Premature baby | 9 | 14.3% | 0 | 9 |
| Maternal exposure during pregnancy | 7 | 11.1% | 0 | 6 |
| Metabolic acidosis | 7 | 11.1% | 0 | 7 |
| Drug hypersensitivity | 6 | 9.5% | 0 | 0 |
| Left-to-right cardiac shunt | 6 | 9.5% | 0 | 6 |
| Neonatal respiratory distress | 6 | 9.5% | 0 | 6 |
Who Reports FLAVOXATE Side Effects? Age & Gender Data
Gender: 81.7% female, 18.3% male. Average age: 69.5 years. Most reports from: JP. View detailed demographics →
Is FLAVOXATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 1 |
| 2014 | 4 | 0 | 0 |
| 2015 | 4 | 0 | 2 |
| 2016 | 11 | 0 | 11 |
| 2017 | 4 | 1 | 1 |
| 2018 | 2 | 0 | 1 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 4 | 0 | 4 |
| 2023 | 8 | 0 | 7 |
| 2024 | 3 | 0 | 2 |
What Is FLAVOXATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 20 |
| Urinary incontinence | 12 |
| Pollakiuria | 6 |
Other Drugs in Same Class: Cholinergic Muscarinic Antagonist [EPC]
Official FDA Label for FLAVOXATE
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Flavoxate HCl tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic. Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H -1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C 24 H 25 NO 4
- HCl. The molecular weight is 427.94. The structural formula appears below: Flavoxate HCl is supplied in tablets for oral administration. Each round, white, film-coated Flavoxate HCl tablet is debossed "PAD" and "0115" on one side and plain on the other side and contains flavoxate hydrochloride, 100 mg. Inactive ingredients consist of colloidal silicon dioxide, ethyl acrylate, hypromellose, lactose monohydrate, magnesium stearate, methyl methacrylate, microcrystalline cellulose, nonoxynol 100 and sodium starch glycolate. Film coating is composed of hypromellose 2910 6cP and polyethylene glycol.
Chemical
Structure
FDA Approved Uses (Indications)
INDICATIONS AND USAGE 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.
Dosage & Administration
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.
Contraindications
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.
Known Adverse Reactions
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.
Warnings
WARNINGS Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
Precautions
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.