{"id":"dimethyl-sulfoxide","rwe":[],"_fda":{"id":"ed5bd01d-2175-457e-ae65-7197f40d7342","set_id":"58b25d79-78f2-4953-b0c6-61658dc4ef0d","openfda":{"unii":["YOW8V9698H"],"route":["INTRAVESICAL"],"rxcui":["208361","562359"],"spl_id":["ed5bd01d-2175-457e-ae65-7197f40d7342"],"brand_name":["RIMSO-50"],"spl_set_id":["58b25d79-78f2-4953-b0c6-61658dc4ef0d"],"package_ndc":["67457-177-50"],"product_ndc":["67457-177"],"generic_name":["DIMETHYL SULFOXIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DIMETHYL SULFOXIDE"],"manufacturer_name":["Mylan Institutional LLC"],"application_number":["NDA017788"],"is_original_packager":[true]},"version":"9","warnings":["WARNINGS Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patients receiving intravesical RIMSO-50 ® . The physician should be cognizant of this possibility in prescribing RIMSO-50 ® . If anaphylactoid symptoms develop, appropriate therapy should be instituted."],"overdosage":["OVERDOSAGE The oral LD 50 of dimethyl sulfoxide in the dog is greater than 10 gm/kg. It is improbable that this dosage level could be obtained with intravesical instillation of RIMSO-50 ® in the patient. In case of accidental oral ingestion, specific measures should be taken to induce emesis. Additional measures which may be considered are gastric lavage, activated charcoal and force diuresis."],"description":["DESCRIPTION RIMSO-50 ® (dimethyl sulfoxide) (DMSO) 50% w/w Aqueous Solution for intravesical instillation. Each mL contains 0.54 gm dimethyl sulfoxide STERILE AND NON-PYROGENIC. Intravesical instillation for the treatment of interstitial cystitis. NOT FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION. The active component of RIMSO-50 ® is dimethyl sulfoxide which has the empirical formula C 2 H 6 OS, and is structurally represented as: Dimethyl sulfoxide is a clear, colorless and essentially odorless liquid which is miscible with water and most organic solvents. Other physical characteristics include: molecular weight 78.13, melting point 18.3° C, and a specific gravity of 1.096. Chemical Structure"],"precautions":["PRECAUTIONS Changes in the refractive index and lens opacities have been seen in monkeys, dogs and rabbits given high doses of dimethyl sulfoxide chronically. Since lens changes were noted in animals, full eye evaluations, including slit lamp examinations, are recommended prior to and periodically during treatment. Approximately every six months patients receiving dimethyl sulfoxide should have a biochemical screening, particularly liver and renal function tests, and complete blood count. Intravesical instillation of RIMSO-50 ® may be harmful to patients with urinary tract malignancy because of dimethyl sulfoxide-induced vasodilation. Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications. Dimethyl sulfoxide caused teratogenic responses in hamsters, rats and mice when administered intraperitoneally at high doses (2.5 to 12 gm/kg). Oral or topical doses of dimethyl sulfoxide did not cause problems of reproduction in rats, mice and hamsters. Topical doses (5 gm/kg first two days, then 2.5 gm/kg - last eight days) produced terata in rabbits, but in another study, topical doses of 1.1 gm/kg days 3 through 16 of gestation failed to produce any abnormalities. There are no adequate and well controlled studies in pregnant women. Dimethyl sulfoxide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 dimethyl sulfoxide is administered to a nursing woman. Safety and effectiveness in children have not been established. Information available to be given to the patient is reprinted at the end of this text."],"how_supplied":["HOW SUPPLIED Vials contain 50 mL of sterile and non-pyrogenic RIMSO-50 ® (50% w/w dimethyl sulfoxide aqueous solution). Dimethyl sulfoxide is clear and colorless. NDC 67457-177-50 carton containing a 50 mL vial Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from strong light. For additional information concerning RIMSO-50®, contact Mylan Institutional LLC, Morgantown, WV 26505. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland"],"effective_time":"20210317","adverse_reactions":["ADVERSE REACTIONS A garlic-like taste may be noted by the patient within a few minutes after instillation of RIMSO-50 ® (dimethyl sulfoxide). This taste may last several hours and because of the presence of metabolites, an odor on the breath and skin may remain for 72 hours. Transient chemical cystitis has been noted following instillation of dimethyl sulfoxide. The patient may experience moderately severe discomfort on administration. Usually this becomes less prominent with repeated administration."],"contraindications":["CONTRAINDICATIONS None known."],"storage_and_handling":["Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from strong light. For additional information concerning RIMSO-50®, contact Mylan Institutional LLC, Morgantown, WV 26505. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Dimethyl sulfoxide is metabolised in man by oxidation to dimethyl sulfone or by reduction to dimethyl sulfide. Dimethyl sulfoxide and dimethyl sulfone are excreted in the urine and feces. Dimethyl sulfide is eliminated through the breath and skin and is responsible for the characteristic odor from patients on dimethyl sulfoxide medication. Dimethyl sulfone can persist in serum for longer than two weeks after a single intravesical instillation. No residual accumulation of dimethyl sulfoxide has occurred in man or lower animals who have received treatment for protracted periods of time. Following topical application, dimethyl sulfoxide is absorbed and generally distributed in the tissues and body fluids."],"indications_and_usage":["INDICATIONS AND USAGE RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract."],"information_for_patients":["INFORMATION FOR PATIENTS (Physician Copy) RIMSO-50 ® is a sterile solution of 50% dimethyl sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician. Some data indicate that dimethyl sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a RIMSO-50 ® instillation. A garlic-like taste may be noted by the patient within a few minutes after instillation of RIMSO-50 ® (dimethyl sulfoxide). This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours. Some patients may experience discomfort on administration of the drug. Usually this becomes less prominent with repeated administration. If you are pregnant or nursing, ask your physician about the advisability of using RIMSO-50 ® . Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods. Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment. RIMSO-50® (dimethyl sulfoxide) irrigation, USP 1013L102 Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Revised: 3/2021 MI:RIMSIG:R5 RIMSO-50 is a registered trademark of Mylan Teoranta, a Viatris Company.","INFORMATION FOR PATIENTS (Patient Copy) RIMSO-50 ® is a sterile solution of 50% dimethyl sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician. Some data indicate that dimethyl sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a RIMSO-50 ® instillation. A garlic-like taste may be noted by the patient within a few minutes after instillation of RIMSO-50 ® (dimethyl sulfoxide). This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours. Some patients may experience discomfort on administration of the drug. Usually this becomes less prominent with repeated administration. If you are pregnant or nursing, ask your physician about the advisability of using RIMSO-50 ® . Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods. Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment."],"spl_unclassified_section":["PRESCRIBING INFORMATION Rx only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Instillation of 50 mL of RIMSO-50 ® (dimethyl sulfoxide) directly into the bladder may be accomplished by catheter or asepto syringe and allow to remain for 15 minutes. Application of an analgesic lubricant gel such as lidocaine jelly to the urethra is suggested prior to insertion of the catheter to avoid spasm. The medication is expelled by spontaneous voiding. It is recommended that the treatment be repeated every two weeks until maximum symptomatic relief is obtained. Thereafter, time intervals between therapy may be increased appropriately. Administration of oral analgesic medication or suppositories containing belladonna and opium prior to the instillation of RIMSO-50 ® can reduce bladder spasm. In patients with severe interstitial cystitis with very sensitive bladders, the initial treatment, and possibly the second and third (depending on patient response) should be done under anesthesia. (Saddle block has been suggested)."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE None known."],"spl_product_data_elements":["RIMSO-50 Dimethyl Sulfoxide Dimethyl Sulfoxide Dimethyl Sulfoxide WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 mL Vial NDC 67457-177-50 50 mL RIMSO-50 ® (dimethyl sulfoxide) irrigation, USP 50 mL (54 gm) 50% w/w Aqueous Solution For Irrigation Only Not for Injection Rx only Vial Sterile. Non-pyrogenic. Contains: 50% w/w dimethyl sulfoxide in water for injection. Usual Dosage: See accompanying prescribing information. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from strong light. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland RIMSO-50 is a registered trademark of Mylan Teoranta, a Viatris Company. MI:177:1C:R5 Mylan.com Rimso-50 (dimethyl sulfoxide) irrigation USP, 50 mL Carton Label"]},"tags":[{"label":"dimethyl sulfoxide","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"G04BX13","category":"atc"},{"label":"Intravesical","category":"route"},{"label":"Irrigant","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Improvement of symptoms in patients with interstitial cystitis","category":"indication"},{"label":"Ulcerative cystitis","category":"indication"},{"label":"Mylan Institutional","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Antioxidants","category":"pharmacology"},{"label":"Cryoprotective Agents","category":"pharmacology"},{"label":"Free Radical Scavengers","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Solvents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"49 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"48 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"47 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"43 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"42 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"40 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"39 reports"},{"date":"","signal":"DYSPEPSIA","source":"FDA FAERS","actionTaken":"29 reports"},{"date":"","signal":"INFUSION RELATED REACTION","source":"FDA FAERS","actionTaken":"28 reports"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"28 reports"}],"commonSideEffects":[{"effect":"chemical cystitis","drugRate":"reported","severity":"unknown"},{"effect":"discomfort","drugRate":"reported","severity":"unknown"},{"effect":"odor on the breath and skin","drugRate":"reported","severity":"unknown"},{"effect":"garlic-like taste","drugRate":"reported","severity":"unknown"}],"contraindications":["Disorder of lens","Kidney disease","Liver function tests abnormal","Malignant tumor of urinary tract proper","Urinary Burning Sensation"]},"trials":[],"aliases":[],"company":"Mylan Institutional","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DIMETHYL SULFOXIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:42:58.672405+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:43:04.035487+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:42:57.777512+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIMETHYL SULFOXIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:43:04.412328+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:56.476004+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:56.476034+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":"2026-04-20T00:43:06.514416+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL504/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:43:05.763165+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA017788","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:42:56.476039+00:00"}},"allNames":"rimso-50","offLabel":[],"synonyms":["dimethyl sulfoxide","DMSO","demavet","demsodrox","methyl sulfoxide","zymso"],"timeline":[{"date":"1978-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from MYLAN INSTITUTIONAL to Mylan Institutional"},{"date":"1978-04-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Mylan Institutional)"},{"date":"2002-11-29","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"},{"date":"2021-01-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Kyorin Pharmaceutical Co Ltd)"}],"aiSummary":"Rimso-50, also known as dimethyl sulfoxide, is a small molecule drug originally developed by Mylan Institutional and currently owned by the same company. It was FDA-approved in 1978 for the improvement of symptoms in patients with interstitial cystitis and ulcerative cystitis. As an off-patent medication, Rimso-50 is available as a generic product. The commercial status of Rimso-50 is generic, with only one generic manufacturer available. Key safety considerations include the need for careful administration and potential side effects.","approvals":[{"date":"1978-04-04","orphan":false,"company":"MYLAN INSTITUTIONAL","regulator":"FDA"},{"date":"2021-01-22","orphan":true,"company":"Kyorin Pharmaceutical Co Ltd","regulator":"PMDA"}],"brandName":"Rimso-50","ecosystem":[{"indication":"Improvement of symptoms in patients with interstitial cystitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Ulcerative cystitis","otherDrugs":[{"name":"pentosan polysulfate","slug":"pentosan-polysulfate","company":"Janssen Pharms"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"dimethyl sulfoxide","explanation":"","oneSentence":"","technicalDetail":"Dimethyl sulfoxide (DMSO) is a small molecule that can cross cell membranes, allowing it to penetrate the bladder wall and exert its anti-inflammatory effects. It is thought to work by scavenging free radicals, reducing oxidative stress, and modulating the activity of various enzymes and cytokines involved in the inflammatory response."},"commercial":{"launchDate":"1978","_launchSource":"DrugCentral (FDA 1978-04-04, MYLAN INSTITUTIONAL)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/906","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIMETHYL%20SULFOXIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIMETHYL SULFOXIDE","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 Book"}],"_enrichedAt":"2026-03-30T10:44:21.246970","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:43:08.533264+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"magnesium hydroxide","drugSlug":"magnesium-hydroxide","fdaApproval":"2000-10-16","relationship":"same-class"},{"drugName":"acetohydroxamic acid","drugSlug":"acetohydroxamic-acid","fdaApproval":"1983-05-31","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"phenazopyridine","drugSlug":"phenazopyridine","fdaApproval":"2001-06-26","relationship":"same-class"},{"drugName":"phenyl salicylate","drugSlug":"phenyl-salicylate","fdaApproval":"","relationship":"same-class"},{"drugName":"pentosan polysulfate","drugSlug":"pentosan-polysulfate","fdaApproval":"1996-09-26","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"tiopronin","drugSlug":"tiopronin","fdaApproval":"1988-08-11","patentExpiry":"Nov 14, 2038","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"dimethyl sulfoxide","indications":{"approved":[{"name":"Improvement of symptoms in patients with interstitial cystitis","source":"DrugCentral","snomedId":197834003,"regulator":"FDA"},{"name":"Ulcerative cystitis","source":"DrugCentral","snomedId":111409009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Mylan Institutional","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"magnesium-hydroxide","brandName":"magnesium hydroxide","genericName":"magnesium hydroxide","approvalYear":"2000","relationship":"same-class"},{"drugId":"acetohydroxamic-acid","brandName":"acetohydroxamic acid","genericName":"acetohydroxamic acid","approvalYear":"1983","relationship":"same-class"},{"drugId":"phenazopyridine","brandName":"phenazopyridine","genericName":"phenazopyridine","approvalYear":"2001","relationship":"same-class"},{"drugId":"phenyl-salicylate","brandName":"phenyl salicylate","genericName":"phenyl salicylate","approvalYear":"","relationship":"same-class"},{"drugId":"pentosan-polysulfate","brandName":"pentosan polysulfate","genericName":"pentosan polysulfate","approvalYear":"1996","relationship":"same-class"},{"drugId":"tiopronin","brandName":"tiopronin","genericName":"tiopronin","approvalYear":"1988","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04439357","phase":"PHASE2","title":"Testing Trametinib as a Potential Targeted Treatment in Cancers With GNAQ or GNA11 Genetic Changes (MATCH-Subprotocol S2)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-02-25","conditions":["Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Hematopoietic and 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