{"id":"flavoxate","rwe":[{"pmid":"41340486","year":"2026","title":"Exploring the selective inhibitory effects of Flavoxate and its analogues on two chloride channels and neuronal action potentials.","finding":"","journal":"The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology","studyType":"Clinical Study"},{"pmid":"41210735","year":"2025","title":"Consensus Virtual Screening and Ex Vivo Evaluation of Novel JAK2/STAT1,3 Inhibitors.","finding":"","journal":"ACS omega","studyType":"Clinical Study"},{"pmid":"41161786","year":"2025","title":"Evaluation of the Potential Inhibitory Effects of Medications for Detrusor Overactivity on Platelet-Activating Factor (PAF)-Induced Mechanical Activity in Guinea Pig Bladder Smooth Muscle.","finding":"","journal":"Biological & pharmaceutical bulletin","studyType":"Clinical Study"},{"pmid":"40923197","year":"2025","title":"Harnessing Chromone as a Versatile Scaffold for Emerging Biological Applications: Recent Advances and Medicinal Insights.","finding":"","journal":"Chemical record (New York, N.Y.)","studyType":"Clinical Study"},{"pmid":"39574420","year":"2024","title":"Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study.","finding":"","journal":"BMJ medicine","studyType":"Clinical Study"}],"_fda":{"id":"ff1c0ee9-75d2-478a-9152-0753be81ff11","set_id":"a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5","openfda":{"upc":["0305740115015"],"unii":["9C05J6089W"],"route":["ORAL"],"rxcui":["1095229"],"spl_id":["ff1c0ee9-75d2-478a-9152-0753be81ff11"],"brand_name":["FLAVOXATE HYDROCHLORIDE"],"spl_set_id":["a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5"],"package_ndc":["0574-0115-01"],"product_ndc":["0574-0115"],"generic_name":["FLAVOXATE HYDROCHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLAVOXATE HYDROCHLORIDE"],"manufacturer_name":["Padagis US LLC"],"application_number":["ANDA076831"],"is_original_packager":[true]},"version":"12","warnings":["WARNINGS Flavoxate HCl should be given cautiously in patients with suspected glaucoma."],"pregnancy":["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":["OVERDOSAGE 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."],"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"],"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 HCl 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 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. 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 HCl is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established."],"how_supplied":["HOW SUPPLIED Flavoxate HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed \"PAD\" and \"0115\" on one side and plain on the other side, in bottles of 100. 100 mg 100's: NDC 0574- 0115 -01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Manufactured For Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 05-23 7H700 RC PH3 Code 917A00"],"pediatric_use":["Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established."],"effective_time":"20230531","nursing_mothers":["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 HCl is administered to a nursing woman."],"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."],"contraindications":["CONTRAINDICATIONS 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle. In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours."],"indications_and_usage":["INDICATIONS AND USAGE 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."],"information_for_patients":["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."],"spl_unclassified_section":["PRESCRIBING INFORMATION"],"dosage_and_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."],"spl_product_data_elements":["FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE FLAVOXATE SILICON DIOXIDE ETHYL ACRYLATE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHYL METHACRYLATE MICROCRYSTALLINE CELLULOSE NONOXYNOL-100 SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL, UNSPECIFIED PAD;0115"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle NDC 0574- 0115 -01 Rx Only Flavoxate HCl Tablets 100 mg 100 Tablets label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate HCl have not been performed."]},"tags":[{"label":"Cholinergic Muscarinic 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Agents","category":"pharmacology"},{"label":"Urological Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"13 reports"},{"date":"","signal":"MUCOSAL INFLAMMATION","source":"FDA FAERS","actionTaken":"10 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"9 reports"},{"date":"","signal":"HEPATIC FUNCTION ABNORMAL","source":"FDA FAERS","actionTaken":"8 reports"},{"date":"","signal":"TOXIC EPIDERMAL NECROLYSIS","source":"FDA FAERS","actionTaken":"8 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"ASPARTATE AMINOTRANSFERASE INCREASED","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"EXPOSED BONE IN JAW","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"ORAL DISORDER","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"OROANTRAL FISTULA","source":"FDA FAERS","actionTaken":"6 reports"}],"drugInteractions":[{"url":"/drug/potassium-chloride","drug":"potassium chloride","action":"Monitor closely","effect":"May interact with Potassium Chloride","source":"DrugCentral","drugSlug":"potassium-chloride"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Vomiting","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Dry mouth","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Vertigo","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Headache","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Mental confusion","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Drowsiness","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Nervousness","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Tachycardia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Palpitation","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Urticaria","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Eosinophilia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Hyperpyrexia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Leukopenia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3}],"contraindications":["Angle-closure glaucoma","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Paralytic ileus","Pyloric obstruction","Urinary tract obstruction"],"specialPopulations":{"Pregnancy":"Use during pregnancy only if clearly needed.","Paediatric use":"Safety and effectiveness in children below the age of 12 years have not been established."}},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.5467/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$200","description":"FLAVOXATE HCL 100 MG 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Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:09:36.963793+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLAVOXATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:09:44.126014+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:36.440023+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:36.440072+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:09:45.582983+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1493/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:09:44.829738+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA076831","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:09:36.440075+00:00"}},"allNames":"urispas","offLabel":[],"synonyms":["urispas","flavoxate","flavoxate hydrochloride","flavoxate HCl"],"timeline":[{"date":"1970-01-15","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"2003-08-28","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Urispas (Flavoxate) is a cholinergic muscarinic antagonist, a small molecule drug that targets the potassium voltage-gated channel subfamily H member 2. It was originally developed and is currently owned by a pharmaceutical company. Urispas is used to treat various urinary tract symptoms such as dysuria, increased urinary frequency, and nocturia. The drug is off-patent and has multiple generic manufacturers. As a cholinergic muscarinic antagonist, Urispas works by blocking the action of acetylcholine at muscarinic receptors in the bladder, reducing muscle spasms and improving urinary flow.","brandName":"Urispas","ecosystem":[{"indication":"Dysuria","otherDrugs":[{"name":"phenazopyridine","slug":"phenazopyridine","company":"Able"},{"name":"secbutabarbital","slug":"secbutabarbital","company":"Meda Pharms"}],"globalPrevalence":null},{"indication":"Increased Urinary Frequency","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"oxybutynin","slug":"oxybutynin","company":""}],"globalPrevalence":null},{"indication":"Nocturia","otherDrugs":[],"globalPrevalence":null},{"indication":"Suprapubic pain","otherDrugs":[],"globalPrevalence":null},{"indication":"Urgent desire to urinate","otherDrugs":[{"name":"butacaine","slug":"butacaine","company":""},{"name":"darifenacin","slug":"darifenacin","company":"Warner Chilcott Llc"},{"name":"fesoterodine","slug":"fesoterodine","company":"Pfizer"},{"name":"oxybutynin","slug":"oxybutynin","company":""}],"globalPrevalence":null},{"indication":"Urinary Tract Irritation","otherDrugs":[{"name":"pentosan polysulfate","slug":"pentosan-polysulfate","company":"Janssen Pharms"},{"name":"phenazopyridine","slug":"phenazopyridine","company":"Able"},{"name":"secbutabarbital","slug":"secbutabarbital","company":"Meda Pharms"}],"globalPrevalence":null},{"indication":"Urinary incontinence","otherDrugs":[{"name":"methanthelinium","slug":"methanthelinium","company":"Shire"}],"globalPrevalence":null}],"mechanism":{"target":"Potassium voltage-gated channel subfamily H member 2","novelty":"Follow-on","targets":[{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"},{"gene":"PDE4A","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4A"},{"gene":"PDE4B","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B"},{"gene":"PDE4C","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4C"},{"gene":"PDE4D","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4D"},{"gene":"PDE7A","source":"DrugCentral","target":"Phosphodiesterase 7","protein":"High affinity cAMP-specific 3',5'-cyclic phosphodiesterase 7A"},{"gene":"PDE7B","source":"DrugCentral","target":"Phosphodiesterase 7","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 7B"},{"gene":"PDE8A","source":"DrugCentral","target":"Phosphodiesterase 8","protein":"High affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8A"},{"gene":"PDE8B","source":"DrugCentral","target":"Phosphodiesterase 8","protein":"High affinity cAMP-specific and IBMX-insensitive 3',5'-cyclic phosphodiesterase 8B"}],"moaClass":"Cholinergic Muscarinic Antagonists","modality":"Small Molecule","drugClass":"Cholinergic Muscarinic Antagonist","explanation":"","oneSentence":"","technicalDetail":"Urispas targets the potassium voltage-gated channel subfamily H member 2 (KCNH2), a type of potassium channel involved in the regulation of bladder smooth muscle contraction. By blocking this channel, Urispas reduces the excitability of the bladder muscle and decreases the frequency of contractions, leading to improved urinary symptoms."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Flavoxate","title":"Flavoxate","extract":"Flavoxate is an anticholinergic with antimuscarinic effects. Its muscle relaxant properties may be due to a direct action on the smooth muscle rather than by antagonizing muscarinic receptors."},"commercial":{"launchDate":"1970","_launchSource":"DrugCentral (FDA 1970-01-15, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1175","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FLAVOXATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLAVOXATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Flavoxate","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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