{"id":"chlorzoxazone","rwe":[{"pmid":"41873911","year":"2026","title":"Low-molecular weight organogel matrices as crystallisation media for active pharmaceutical ingredients.","finding":"","journal":"Journal of materials chemistry. B","studyType":"Clinical Study"},{"pmid":"41859370","year":"2026","title":"Expired chlorzoxazone/N-acetyl-para-aminophenol as corrosion inhibitor for 304 stainless steel in hydrochloric acid.","finding":"","journal":"RSC advances","studyType":"Clinical Study"},{"pmid":"41787256","year":"2026","title":"IL3RA identified as novel biomarker and therapeutic target for ER(+) breast cancer through plasma proteome-wide mendelian randomization and TCGA database analysis.","finding":"","journal":"Clinical proteomics","studyType":"Clinical Study"},{"pmid":"41739569","year":"2026","title":"Alleviation of cerebellar impairment, cognitive decline, and depression by a chlorzoxazone-folic acid combination in a Huntington's disease transgenic mouse model.","finding":"","journal":"Journal of Huntington's disease","studyType":"Clinical Study"},{"pmid":"41687425","year":"2026","title":"Gut microbiota influence pharmacokinetics variability in aging mice: Effects vary from drug to drug.","finding":"","journal":"Drug metabolism and disposition: the biological fate of chemicals","studyType":"Clinical Study"}],"_fda":{"id":"8b8a3310-04e1-4930-8c69-9f8d470b8925","set_id":"0a8ee5fa-f393-4568-81bd-269f9a4cecd6","openfda":{"nui":["N0000175730","N0000175737"],"upc":["0371205711306"],"unii":["H0DE420U8G"],"route":["ORAL"],"rxcui":["197502"],"spl_id":["8b8a3310-04e1-4930-8c69-9f8d470b8925"],"brand_name":["CHLORZOXAZONE"],"spl_set_id":["0a8ee5fa-f393-4568-81bd-269f9a4cecd6"],"package_ndc":["71205-711-20","71205-711-30","71205-711-60","71205-711-90"],"product_ndc":["71205-711"],"generic_name":["CHLORZOXAZONE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_pe":["Centrally-mediated Muscle Relaxation [PE]"],"substance_name":["CHLORZOXAZONE"],"pharm_class_epc":["Muscle Relaxant [EPC]"],"manufacturer_name":["Proficient Rx LP"],"application_number":["ANDA089853"],"original_packager_product_ndc":["59651-306"]},"version":"2","warnings":["WARNINGS Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin.) The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Usage in Pregnancy The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks."],"overdosage":["OVERDOSAGE Symptoms Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed. Treatment Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used."],"description":["DESCRIPTION Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is: Chlorzoxazone,USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone tablets contain the inactive ingredients -Lactose monohydrate USNF, Microcrystalline cellulose USNF, FD&C Yellow 6/Sunset Yellow FCF Aluminium lake, D&C Red 27/Phloxine Aluminium lake, Hypromellose USP (a) Binder solution Hypromellose USP (b), Polysarbate 80 USNF, Ethanol (96%v/v). Extragranrular Pregelatinized Starch USNF, Sodium starch glycolate USNF, Magnesium stearate USNF. FDA approved dissolution method differs from that of the USP. structure"],"precautions":["PRECAUTIONS Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped. If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued."],"how_supplied":["HOW SUPPLIED Chlorzoxazone tablets, USP 500 mg are available as Light orange to orange round shaped, flat hexagonal, beveled debossed with “N” on one side of break line and “500” on other side of break line and plain on other side. Bottles of 20 NDC 71205-711-20 Bottles of 30 NDC 71205-711-30 Bottles of 60 NDC 71205-711-60 Bottles of 90 NDC 71205-711-90 Store at controlled room temperature 15°- 30°C (59°-86° F). Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF. Keep out of the reach of children. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 11/2021"],"effective_time":"20250301","adverse_reactions":["ADVERSE REACTIONS Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient. Rarely, allergic type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance. To report SUSPECTED ADVERSE EVENTS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions."],"contraindications":["CONTRAINDICATIONS Chlorzoxazone is contraindicated in patients with known intolerance to the drug."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours."],"indications_and_usage":["INDICATIONS Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual Adult Dosage One tablet three or four times daily. If adequate response is not obtained with this dose, it may be increased to one and one-half tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced."],"spl_product_data_elements":["CHLORZOXAZONE CHLORZOXAZONE CHLORZOXAZONE CHLORZOXAZONE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE FD&C YELLOW NO. 6 D&C RED NO. 27 HYPROMELLOSE 2910 (3 MPA.S) POLYSORBATE 80 ALCOHOL STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE Light orange to orange flat, hexagonal N;500"],"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (30 Tablets Bottle) NDC 71205-711-30 Rx only Chlorzoxazone Tablets, USP 500 mg 30 Tablets 71205-711-30"]},"tags":[{"label":"Muscle Relaxant","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Nitric oxide synthase, endothelial","category":"target"},{"label":"NOS3","category":"gene"},{"label":"NOS2","category":"gene"},{"label":"KCNMA1","category":"gene"},{"label":"M03BB03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Occlusive Dressing Technique","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Muscle Spasm with Pain","category":"indication"},{"label":"Spasticity","category":"indication"},{"label":"Ortho Mcneil Pharm","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Muscle Relaxants, Central","category":"pharmacology"},{"label":"Neuromuscular Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"94 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"94 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"92 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"90 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"81 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"73 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"56 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"53 reports"},{"date":"","signal":"SOMNOLENCE","source":"FDA FAERS","actionTaken":"51 reports"}],"drugInteractions":[{"url":"/drug/disulfiram","drug":"disulfiram","action":"Monitor closely","effect":"May interact with Disulfiram","source":"DrugCentral","drugSlug":"disulfiram"},{"url":"/drug/sodium-oxybate","drug":"sodium oxybate","action":"Avoid combination","effect":"May interact with Sodium Oxybate","source":"DrugCentral","drugSlug":"sodium-oxybate"}],"commonSideEffects":[{"effect":"Gastrointestinal bleeding","drugRate":"reported","severity":"unknown"},{"effect":"Drowsiness","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Lightheadedness","drugRate":"reported","severity":"unknown"},{"effect":"Malaise","drugRate":"reported","severity":"unknown"},{"effect":"Over-stimulation","drugRate":"reported","severity":"unknown"},{"effect":"Allergic type skin rashes","drugRate":"reported","severity":"unknown"},{"effect":"Petechiae","drugRate":"reported","severity":"unknown"},{"effect":"Ecchymoses","drugRate":"reported","severity":"unknown"},{"effect":"Angioneurotic edema","drugRate":"reported","severity":"unknown"},{"effect":"Anaphylactic reactions","drugRate":"reported","severity":"unknown"},{"effect":"Discoloration of the urine","drugRate":"reported","severity":"unknown"}],"contraindications":["Alcoholism","Disease of liver","Drug-induced hepatitis","Hepatic failure","Liver function tests abnormal","Poisoning by acetaminophen"],"specialPopulations":{"Pregnancy":"The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks."}},"trials":[],"aliases":[],"company":"Johnson & Johnson","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.2440/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$89","description":"CHLORZOXAZONE 500 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CHLORZOXAZONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:15:01.449269+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:15:08.030769+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:15:00.034013+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORZOXAZONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:15:08.842622+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:58.214509+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:58.214569+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:58.214795+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":"2026-04-20T03:15:10.343176+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Intermediate conductance calcium-activated potassium channel protein 4 opener","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:15:09.424540+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1371/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:15:09.313558+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA089853","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:14:58.214827+00:00"}},"allNames":"parafon forte dsc","offLabel":[],"synonyms":["chlorzoxazone","5-Chlorobenzoxazolidone","chlorzoxazon","chloroxazone"],"timeline":[{"date":"1958-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from JANSSEN R AND D to Ortho Mcneil Pharm"},{"date":"1958-08-15","type":"positive","source":"DrugCentral","milestone":"FDA approval (Janssen R And D)"},{"date":"1987-06-15","type":"positive","source":"FDA Orange Book","milestone":"Parafon Forte Dsc approved — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"}],"aiSummary":"Parafon Forte DSC (CHLORZOXAZONE) is a muscle relaxant medication originally developed by Janssen R and D and currently owned by Ortho McNeil Pharm. It targets nitric oxide synthase in endothelial cells to provide relief from muscle spasm and pain. This medication has been FDA-approved since 1958 for treating muscle spasm with pain and spasticity. Parafon Forte DSC is available as a generic medication, with 21 generic manufacturers, and is off-patent. As a result, it is widely available and affordable.","approvals":[{"date":"1958-08-15","orphan":false,"company":"JANSSEN R AND D","regulator":"FDA"}],"brandName":"Parafon Forte Dsc","ecosystem":[{"indication":"Muscle Spasm with Pain","otherDrugs":[{"name":"carisoprodol","slug":"carisoprodol","company":"Meda Pharms"},{"name":"codeine","slug":"codeine","company":"Ani Pharms"},{"name":"methocarbamol","slug":"methocarbamol","company":"Auxilium Pharms Llc"}],"globalPrevalence":null},{"indication":"Spasticity","otherDrugs":[{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"carisoprodol","slug":"carisoprodol","company":"Meda Pharms"},{"name":"chlorphenesin carbamate","slug":"chlorphenesin-carbamate","company":"Pharmacia And Upjohn"},{"name":"cyclobenzaprine","slug":"cyclobenzaprine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Nitric oxide synthase, endothelial","novelty":"Follow-on","targets":[{"gene":"NOS3","source":"DrugCentral","target":"Nitric oxide synthase, endothelial","protein":"Nitric oxide synthase, endothelial"},{"gene":"NOS2","source":"DrugCentral","target":"Nitric oxide synthase, inducible","protein":"Nitric oxide synthase, inducible"},{"gene":"KCNMA1","source":"DrugCentral","target":"Calcium-activated potassium channel subunit alpha-1","protein":"Calcium-activated potassium channel subunit alpha-1"},{"gene":"NOS1","source":"DrugCentral","target":"Nitric oxide synthase, brain","protein":"Nitric oxide synthase, brain"},{"gene":"KCNN4","source":"DrugCentral","target":"Intermediate conductance calcium-activated potassium channel protein 4","protein":"Intermediate conductance calcium-activated potassium channel protein 4"}],"modality":"Small Molecule","drugClass":"Muscle Relaxant [EPC]","explanation":"","oneSentence":"","technicalDetail":"Parafon Forte DSC (CHLORZOXAZONE) is a small molecule that acts as a non-selective inhibitor of nitric oxide synthase (NOS), specifically targeting the endothelial isoform (eNOS), which plays a crucial role in the regulation of vascular tone and muscle contraction."},"commercial":{"launchDate":"1958","_launchSource":"DrugCentral (FDA 1958-08-15, JANSSEN R AND D)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/626","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CHLORZOXAZONE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORZOXAZONE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"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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(CHUM)","startDate":"2015-04","conditions":["Type 2 Diabetes"],"enrollment":73,"completionDate":"2019-07"},{"nctId":"NCT03563287","phase":"NA","title":"Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs","status":"COMPLETED","sponsor":"University of Eastern Finland","startDate":"2012-01-27","conditions":["Obesity, Morbid","Bariatric Surgery Candidate"],"enrollment":13,"completionDate":"2014-12-10"},{"nctId":"NCT03103568","phase":"PHASE1","title":"A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers","status":"COMPLETED","sponsor":"Swedish Orphan Biovitrum","startDate":"2017-03-28","conditions":["Drug Drug Interaction"],"enrollment":36,"completionDate":"2017-07-24"},{"nctId":"NCT01933542","phase":"PHASE4","title":"The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery","status":"COMPLETED","sponsor":"Rigshospitalet, 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