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Prescription medicine

Dimethyl sulfoxide Brand names: Rimso; first approved as Rimso-50

Dimethyl sulfoxide (Rimso-50) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 1 generic labeler.

  • Generic listed

Check it at the source: the dimethyl sulfoxide FDA label on DailyMed (effective March 17, 2021, Mylan Institutional LLC); the NDA 17788 record on Drugs@FDA; every dimethyl sulfoxide label on DailyMed.

Highlights of the record

FDA label of March 17, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis.

Forms and strengths

  • 0.54 g/ml

Irrigant.

On the market

Earliest approval on file
April 4, 1978 Rimso-50, Mylan Institutional; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
2 first November 29, 2002; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC)
2 of which 1 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
FAERS reports
239 through July 30, 2026

What is dimethyl sulfoxide used for?

From the label: 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.

Source: FDA drug label (RIMSO-50), Mylan Institutional LLC, effective March 17, 2021 (SPL set 58b25d79-78f2-4953-b0c6-61658dc4ef0d), via openFDA; the full label on DailyMed

Is there a generic for dimethyl sulfoxide (Rimso-50)?

The FDA approved the first generic dimethyl sulfoxide on November 29, 2002. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists dimethyl sulfoxide from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1978 earliest approval on file
  • 2002 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has dimethyl sulfoxide been recalled?

The FDA's Enforcement Report lists 1 recall naming dimethyl sulfoxide since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of dimethyl sulfoxide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
April 10, 2013Class IIFVS Holdings, Inc. dba. Green Valley Drugs not a listed makerLack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the dimethyl sulfoxide label say about other medicines?

The dimethyl sulfoxide label names no other medicine on this site. The labels of 2 other medicines name dimethyl sulfoxide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name dimethyl sulfoxide

Check dimethyl sulfoxide against other medicines

Source: FDA drug label (RIMSO-50), Mylan Institutional LLC, effective March 17, 2021 (SPL set 58b25d79-78f2-4953-b0c6-61658dc4ef0d), via openFDA; the full label on DailyMed

What do FAERS reports show for dimethyl sulfoxide?

The FDA Adverse Event Reporting System holds 239 reports that list dimethyl sulfoxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 82 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)49
  • Headache48
  • Nausea48
  • Off Label Use (a use or a product term, not a reaction)42
  • Abdominal Pain41
  • Pyrexia39
  • Pain38
  • Dyspepsia28

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Dimethyl sulfoxide side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other