pharmacopeia
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/api/v1/drug/flavoxate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cholinergic Muscarinic Antagonists; Phosphodiesterase Inhibitors.

Cholinergic MuscarinicPhosphodiesterase

Indications

Sourced from openFDA
  • Flavoxate HCl 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 HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.ICD-10: N39.0

Contraindications

Sourced from openFDA
  • Flavoxate HCl tablets are 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.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

Flavoxate HCl should be given cautiously in patients with suspected glaucoma.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

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 HCl. 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.

Overdosage

Sourced from openFDA

The oral LD 50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD 50 for flavoxate HCl in mice is 1837 mg/kg. It is not known whether flavoxate HCl is dialyzable.

Approval history

Sourced from openFDA
  • Dec 16, 2004ANDAANDA076831Padagis Us
  • Nov 30, 2005ANDAANDA076835Epic Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
100 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pyrexia1313%
  2. 2Mucosal Inflammation1010%
  3. 3Pruritus99.0%
  4. 4Hepatic Function Abnormal88.0%
  5. 5Toxic Epidermal Necrolysis88.0%
  6. 6Pneumonia77.0%
  7. 7Aspartate Aminotransferase Increased66.0%
  8. 8Exposed Bone In Jaw66.0%
  9. 9Oral Disorder66.0%
  10. 10Oroantral Fistula66.0%
  11. 11Osteonecrosis Of Jaw66.0%
  12. 12Alanine Aminotransferase Increased55.0%
  13. 13Blood Lactate Dehydrogenase Increased55.0%
  14. 14Decreased Appetite55.0%
  15. 15Lip Erosion55.0%

Literature

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Recent PubMed references pinned to Flavoxate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Flavoxate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Flavoxate work?
Mechanism-of-action classes: Cholinergic Muscarinic Antagonists; Phosphodiesterase Inhibitors.
What is Flavoxate used for?
According to FDA labeling, Flavoxate carries indications including: Flavoxate HCl 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 HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Flavoxate?
Flavoxate is classified as Drugs for urinary frequency and incontinence, Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists, Phosphodiesterase Inhibitors, Decreased Smooth Muscle Nerve Growth Factor Activity.
What are the contraindications for Flavoxate?
Flavoxate labeling lists contraindications including: Flavoxate HCl tablets are 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.. Always consult the full prescribing information and a clinician.
Note. Data for flavoxate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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