{"id":"methocarbamol","rwe":[{"pmid":"41866376","year":"2026","title":"Comparative greenness assessment for the simultaneous estimation of diclofenac and methocarbamol in their tablets applying synchronous fluorimetry.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41841242","year":"2026","title":"Evolving Analytical Methods for the Quantification of Methocarbamol: A Critical Review.","finding":"","journal":"Biomedical chromatography : BMC","studyType":"Clinical Study"},{"pmid":"41789190","year":"2026","title":"Pelvic Inflammatory Disease With Presumptive Tubo-Ovarian Abscess Presenting With Rectal Spasm.","finding":"","journal":"Case reports in obstetrics and gynecology","studyType":"Clinical Study"},{"pmid":"41690384","year":"2026","title":"Management of acute withdrawal from 7-hydroxymitragynine following high-dose chronic use: A case report.","finding":"","journal":"Journal of the American Pharmacists Association : JAPhA","studyType":"Clinical Study"},{"pmid":"41492604","year":"2025","title":"Postoperative Pain Management in Patients with Lower-Extremity Amputations: A Single-Institution Retrospective Analysis of the Effectiveness of Non-opioid Analgesics in Reduction of Opioid Use.","finding":"","journal":"Cureus","studyType":"Clinical Study"}],"_fda":{"id":"948f25be-b1ae-4bc9-9272-9f0af5bb3196","set_id":"0003eccd-6147-4a7c-ae83-b2a94933e07d","openfda":{"nui":["N0000175730","N0000175737"],"unii":["125OD7737X"],"route":["ORAL"],"rxcui":["197944"],"spl_id":["948f25be-b1ae-4bc9-9272-9f0af5bb3196"],"brand_name":["Methocarbamol"],"spl_set_id":["0003eccd-6147-4a7c-ae83-b2a94933e07d"],"package_ndc":["63187-130-30","63187-130-40","63187-130-45","63187-130-60","63187-130-90"],"product_ndc":["63187-130"],"generic_name":["METHOCARBAMOL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_pe":["Centrally-mediated Muscle Relaxation [PE]"],"substance_name":["METHOCARBAMOL"],"pharm_class_epc":["Muscle Relaxant [EPC]"],"manufacturer_name":["Proficient Rx LP"],"application_number":["ANDA086988"],"original_packager_product_ndc":["43547-226"]},"version":"7","warnings":["WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Precautions, Pregnancy ). Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities."],"pregnancy":["Pregnancy Teratogenic effects Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol tablets, USP should be given to a pregnant woman only if clearly needed. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Warnings ). Nursing mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methocarbamol tablets, USP are administered to a nursing woman. Pediatric use Safety and effectiveness of Methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established."],"overdosage":["OVERDOSAGE Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs. Treatment Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown."],"description":["DESCRIPTION Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5 . Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n -hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: povidone, sodium starch glycolate and magnesium stearate. Methocarbamol Chemical Structure"],"precautions":["PRECAUTIONS Information for patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants. Drug interactions See Warnings and Precautions for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents. Drug/laboratory test interactions Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method. Carcinogenesis, mutagenesis, impairment of fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility. Pregnancy Teratogenic effects Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol tablets, USP should be given to a pregnant woman only if clearly needed. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Warnings ). Nursing mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methocarbamol tablets, USP are administered to a nursing woman. Pediatric use Safety and effectiveness of Methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established."],"how_supplied":["HOW SUPPLIED Methocarbamol tablets, USP 750 mg tablets are modified capsule shape, white to off-white tablet, debossed S 226 on one side and plain on the reverse side. They are supplied as follows: Bottles of 30 NDC 63187-130-30 Bottles of 40 NDC 63187-130-40 Bottles of 45 NDC 63187-130-45 Bottles of 60 NDC 63187-130-60 Bottles of 90 NDC 63187-130-90 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in tight container."],"pediatric_use":["Pediatric use Safety and effectiveness of Methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established."],"effective_time":"20200801","nursing_mothers":["Nursing mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methocarbamol tablets, USP are administered to a nursing woman."],"pharmacokinetics":["Pharmacokinetics In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%. Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine."],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria"],"contraindications":["CONTRAINDICATIONS Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components."],"drug_interactions":["Drug interactions See Warnings and Precautions for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents."],"teratogenic_effects":["Teratogenic effects Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol tablets, USP should be given to a pregnant woman only if clearly needed. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Warnings )."],"storage_and_handling":["Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in tight container."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber."],"indications_and_usage":["INDICATIONS AND USAGE Methocarbamol tablets, USP are 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man."],"information_for_patients":["Information for patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants."],"spl_unclassified_section":["R x only Solco Healthcare U.S., LLC","Special populations","Elderly The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (± 0.4) hours versus 1.1 (± 0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).","Renally impaired The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (± 0.3) hours, respectively.","Hepatically impaired In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (± 1.62) hours and 1.11 (± 0.27) hours, respectively.The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.","To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare at 1-888-869-8008 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.","Manufactured for: Solco Healthcare U.S. Solco Healthcare U.S., LLC Cranbury, NJ 08512 Manufactured by: Emcure Pharmaceuticals USA Inc. 21-B, Cotters Lane East Brunswick, NJ 08816 Prinston Laboratories 3241 Woodpark Blvd Charlotte, NC 28206 M.F. # 0301-01 Rev. October 2012. R x only Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Methocarbamol tablets, USP, 500 mg – Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol tablets, USP: 750 mg – Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day."],"spl_product_data_elements":["Methocarbamol Methocarbamol METHOCARBAMOL METHOCARBAMOL POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE white to off-white capsule-shaped S226"],"package_label_principal_display_panel":["750 mg Label 63187-130-40"],"drug_and_or_laboratory_test_interactions":["Drug/laboratory test interactions Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, mutagenesis, impairment of fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility."]},"tags":[{"label":"Muscle Relaxant","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Carbonic anhydrase 1","category":"target"},{"label":"CA1","category":"gene"},{"label":"M03BA03","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Parenteral","category":"route"},{"label":"Injection","category":"form"},{"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":"Tetanus Adjunct Treatment","category":"indication"},{"label":"Hikma","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":"PAIN","source":"FDA FAERS","actionTaken":"1641 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1565 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1531 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1434 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1203 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1079 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"1047 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"995 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"966 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"911 reports"}],"commonSideEffects":[{"effect":"Anaphylactic reaction","drugRate":"reported","severity":"unknown"},{"effect":"Angioneurotic edema","drugRate":"reported","severity":"unknown"},{"effect":"Fever","drugRate":"reported","severity":"unknown"},{"effect":"Headache","drugRate":"reported","severity":"unknown"},{"effect":"Bradycardia","drugRate":"reported","severity":"unknown"},{"effect":"Flushing","drugRate":"reported","severity":"unknown"},{"effect":"Hypotension","drugRate":"reported","severity":"unknown"},{"effect":"Syncope","drugRate":"reported","severity":"unknown"},{"effect":"Thrombophlebitis","drugRate":"reported","severity":"unknown"},{"effect":"Dyspepsia","drugRate":"reported","severity":"unknown"},{"effect":"Jaundice","drugRate":"reported","severity":"unknown"},{"effect":"Nausea and vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Leukopenia","drugRate":"reported","severity":"unknown"},{"effect":"Hypersensitivity reactions","drugRate":"reported","severity":"unknown"},{"effect":"Amnesia","drugRate":"reported","severity":"unknown"},{"effect":"Confusion","drugRate":"reported","severity":"unknown"},{"effect":"Diplopia","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness or lightheadedness","drugRate":"reported","severity":"unknown"},{"effect":"Drowsiness","drugRate":"reported","severity":"unknown"},{"effect":"Insomnia","drugRate":"reported","severity":"unknown"},{"effect":"Mild muscular incoordination","drugRate":"reported","severity":"unknown"},{"effect":"Nystagmus","drugRate":"reported","severity":"unknown"},{"effect":"Sedation","drugRate":"reported","severity":"unknown"},{"effect":"Seizures","drugRate":"reported","severity":"unknown"},{"effect":"Vertigo","drugRate":"reported","severity":"unknown"},{"effect":"Blurred vision","drugRate":"reported","severity":"unknown"},{"effect":"Conjunctivitis","drugRate":"reported","severity":"unknown"},{"effect":"Nasal congestion","drugRate":"reported","severity":"unknown"},{"effect":"Metallic taste","drugRate":"reported","severity":"unknown"},{"effect":"Pruritus","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute erosive gastritis","Acute nephropathy","Alcoholism","Anemia","Anemia due to enzyme deficiency","Breastfeeding (mother)","Disease of liver","Factor II deficiency","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Gout","Hemophilia","Kidney disease","Nasal polyp","Peptic ulcer","Pregnancy, function","Reye's syndrome","Seizure disorder","Thrombocytopenic disorder","Thrombotic thrombocytopenic purpura","Vitamin K deficiency","von Willebrand disorder"],"specialPopulations":{"Pregnancy":"Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Methocarbamol should be given to pregnant woman only if clearly needed.","Geriatric use":"The mean (+- SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean [+- SD] age, 69 [+- 4] years) was slightly prolonged compared to younger (mean [+- SD] age, 53.3 [+- 8.8] years), healthy population (1.5 [+-0.4] hours versus 1.1 [+- 0.27] hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).","Paediatric use":"Safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.","Renal impairment":"The clearance of methocarbamol in renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (+- SD) elimination half-life in these two groups was similar: 1.2 (+- 0.6) versus 1.1 (+- 0.3) hours, respectively.","Hepatic impairment":"In patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in age- and weight-matched normal subjects. The mean (+- SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (+-1.62) hours and 1.11 (+- 0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects."}},"trials":[],"aliases":[],"company":"Hikma","patents":[{"type":"Formulation","number":"12390439","applicant":"ROSEMONT PHARMACEUTICALS INC","territory":"US","tradeName":"ATMEKSI","expiryDate":"2044-10-09"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0435/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$16","description":"METHOCARBAMOL 500 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=METHOCARBAMOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:31:49.242511+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:31:49.242424+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:31:56.720791+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:31:48.364004+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=METHOCARBAMOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:31:57.117680+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":"2026-04-20T00:31:45.715639+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:31:45.715659+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:31:45.715663+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":"2026-04-20T00:31:58.608086+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Carbonic anhydrase I inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:31:58.165009+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201117/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:31:57.817709+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA086988","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:31:45.715666+00:00"}},"allNames":"robaxin","offLabel":[],"synonyms":["methocarbamol","glycerylguaiacolate carbamate","guaiacol glyceryl ether carbamate","guaiphenesin carbamate","guaiamar carbamate"],"timeline":[{"date":"1957-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from AUXILIUM PHARMS LLC to Hikma"},{"date":"1957-07-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Auxilium Pharms Llc)"},{"date":"2025-07-30","type":"positive","source":"FDA Orange Book","milestone":"Atmeksi approved — 750MG/5ML"}],"aiSummary":"Robaxin (METHOCARBAMOL) is a small molecule muscle relaxant developed by AUXILIUM PHARMS LLC and currently owned by Hikma. It targets carbonic anhydrase 1 to treat muscle spasm with pain, spasticity, and tetanus adjunct treatment. Robaxin is an off-patent medication with 51 generic manufacturers, approved by the FDA in 1957. As a muscle relaxant, it is used to alleviate muscle spasms and associated pain. Key safety considerations include its potential for drowsiness and interactions with other medications.","approvals":[{"date":"1957-07-16","orphan":false,"company":"AUXILIUM PHARMS LLC","regulator":"FDA"}],"brandName":"Robaxin","ecosystem":[{"indication":"Muscle Spasm with Pain","otherDrugs":[{"name":"carisoprodol","slug":"carisoprodol","company":"Meda Pharms"},{"name":"chlorzoxazone","slug":"chlorzoxazone","company":"Janssen R And D"},{"name":"codeine","slug":"codeine","company":"Ani Pharms"}],"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":"chlorzoxazone","slug":"chlorzoxazone","company":"Janssen R And D"}],"globalPrevalence":null},{"indication":"Tetanus Adjunct 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