Dimethyl Sulfoxide

Dimethyl Sulfoxide is an FDA-registered drug product whose active ingredient is DIMETHYL SULFOXIDE. It is labelled by Renova Pharmaceuticals LLC taken by intravesical and marketed as a human prescription drug product. Identifiers on file: NDC 84897-052, application ANDA220173, label effective 20260720. It is one of 2 FDA drug label records sharing the active ingredient DIMETHYL SULFOXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIMETHYL SULFOXIDE are most often described in connection with: dimethyl sulfoxide, symptomatic relief, interstitial cystitis, clinical evidence, treatment bacterial, urinary tract. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Dimethyl sulfoxide is indicated for the symptomatic relief of patients with interstitial cystitis. Dimethyl sulfoxide 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.

DOSAGE AND ADMINISTRATION Instillation of 50 mL of 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 dimethyl sulfoxide 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).

CONTRAINDICATIONS None known.

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 dimethyl sulfoxide. The physician should be cognizant of this possibility in prescribing dimethyl sulfoxide. If anaphylactoid symptoms develop, appropriate therapy should be instituted.

ADVERSE REACTIONS A garlic-like taste may be noted by the patient within a few minutes after instillation of 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.

FDA lists 2 drug label records with DIMETHYL SULFOXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Dimethyl Sulfoxide used for?
INDICATIONS AND USAGE Dimethyl sulfoxide is indicated for the symptomatic relief of patients with interstitial cystitis. Dimethyl sulfoxide 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.

Who makes Dimethyl Sulfoxide?
Renova Pharmaceuticals LLC is the labeler of record for Dimethyl Sulfoxide. 2 FDA label records share the active ingredient DIMETHYL SULFOXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Dimethyl Sulfoxide come in?
administered by intravesical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Dimethyl Sulfoxide prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIMETHYL SULFOXIDE?
Yes. 2 FDA drug label records list DIMETHYL SULFOXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Dimethyl Sulfoxide been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.