Skip to main content

What the label lists and what reports show

Dimethyl sulfoxide side effects

Dimethyl sulfoxide's FDA label lists its adverse reactions in its own words. FAERS holds 239 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (48 reports).

  • Generic listed

Check it at the source: the dimethyl sulfoxide FDA label on DailyMed (effective March 17, 2021, Mylan Institutional LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: 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.

Source: FDA drug label, 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?

239 reports list dimethyl sulfoxide among the medicines taken, 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. Of the 21 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 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
  • Constipation27
  • Fatigue27
  • Infusion Related Reaction27
  • Malaise27
  • Weight Decreased26
  • Anaemia25
  • Erythema25
  • Macular Degeneration25
  • Paraesthesia Oral25
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)25
  • Chronic Sinusitis24
  • Haematochezia24
  • Oral Candidiasis24
  • Procedural Pain24
  • Colitis23
  • Colitis Ulcerative23
  • Drug Interaction (a use or a product term, not a reaction)23

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Dimethyl sulfoxide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions