Dimethyl Sulfoxide side effects: what 238 FDA adverse event reports show

Dimethyl Sulfoxide · 16 reaction terms · 295 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

238 reports · 83% serious · 31 with death outcome · 65% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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.

FDA label, Indications and Usage

What it is

DESCRIPTION Dimethyl Sulfoxide (DMSO) Irrigation, USP 50% w/w Aqueous Solution for intravesical instillation.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 16 strongest signals

Lab value / disease marker 1No label text to screen 15

What the badges mean

Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vaginal discharge	22	192.6 129.2–286.9ROR 212.0 · χ² 3,996 / p <1e-300	164.9 EB05 114.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=22	no trial data cached
Macular degeneration	25	184.4 127.2–267.4ROR 205.9 · χ² 4,372 / p <1e-300	161.5 EB05 115.1 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 138.7 · ♀ 100% (drug 65%)	no trial data cached
Oral candidiasis (oral thrush)	24	162.1 110.9–237.1ROR 180.1 · χ² 3,679 / p <1e-300	143.6 EB05 101.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 158.4 · ♀ 100% (drug 65%)	no trial data cached
Respiratory depression	22	157.7 105.8–234.9ROR 173.6 · χ² 3,266 / p <1e-300	138.7 EB05 96.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 113.2 · ♀ 27% (drug 65%)	no trial data cached
Paraesthesia oral	25	152.9 105.5–221.6ROR 170.6 · χ² 3,618 / p <1e-300	136.9 EB05 97.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 190.4 · ♀ 100% (drug 65%)	no trial data cached
Brain oedema	13	90.4 53.3–153.4ROR 95.6 · χ² 1,061 / p 4e-233	80.1 EB05 49.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.7	no trial data cached
Procedural pain	24	76.2 52.1–111.4ROR 84.6 · χ² 1,707 / p <1e-300	71.9 EB05 50.9 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 91.6 · ♀ 100% (drug 65%)	no trial data cached
Frequent bowel movements	23	75.1 50.9–110.7ROR 82.9 · χ² 1,608 / p <1e-300	70.8 EB05 49.7 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 80.8	no trial data cached
Arteriosclerosis	6	55.9 25.3–123.1ROR 57.3 · χ² 271 / p 4e-61	47.8 EB05 23.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.3	no trial data cached
Colitis	23	53.6 36.3–79.1ROR 59.2 · χ² 1,137 / p 2e-249	51.4 EB05 36.1 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.3	no trial data cached
Neutrophil count increased	6	51.2 23.2–112.9ROR 52.5 · χ² 247 / p 5e-56	44.4 EB05 21.7 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 39.3	no trial data cached
Rectal haemorrhage	23	46.8 31.7–69.1ROR 51.7 · χ² 988 / p 4e-217	45.2 EB05 31.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.0	no trial data cached
Pulmonary congestion	7	46.4 22.4–96.3ROR 47.8 · χ² 267 / p 2e-60	41.5 EB05 21.5 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.7	no trial data cached
Colitis ulcerative	23	45.3 30.7–66.8ROR 50.0 · χ² 953 / p 1e-209	43.7 EB05 30.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.0	no trial data cached
Haematochezia (blood in stool)	24	38.2 26.2–55.9ROR 42.4 · χ² 835 / p 6e-184	37.2 EB05 26.3 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.4 · ♀ 100% (drug 65%)	no trial data cached
Injection site extravasation	5	35.2 14.8–83.7ROR 35.9 · χ² 134 / p 3e-31	30.3 EB05 12.4 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Paraesthesia oral	25	152.9 105.5–221.6ROR 170.6 · χ² 3,618 / p <1e-300	136.9 EB05 97.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 190.4 · ♀ 100% (drug 65%)	no trial data cached
Macular degeneration	25	184.4 127.2–267.4ROR 205.9 · χ² 4,372 / p <1e-300	161.5 EB05 115.1 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 138.7 · ♀ 100% (drug 65%)	no trial data cached
Haematochezia (blood in stool)	24	38.2 26.2–55.9ROR 42.4 · χ² 835 / p 6e-184	37.2 EB05 26.3 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.4 · ♀ 100% (drug 65%)	no trial data cached
Procedural pain	24	76.2 52.1–111.4ROR 84.6 · χ² 1,707 / p <1e-300	71.9 EB05 50.9 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 91.6 · ♀ 100% (drug 65%)	no trial data cached
Oral candidiasis (oral thrush)	24	162.1 110.9–237.1ROR 180.1 · χ² 3,679 / p <1e-300	143.6 EB05 101.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 158.4 · ♀ 100% (drug 65%)	no trial data cached
Colitis ulcerative	23	45.3 30.7–66.8ROR 50.0 · χ² 953 / p 1e-209	43.7 EB05 30.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.0	no trial data cached
Rectal haemorrhage	23	46.8 31.7–69.1ROR 51.7 · χ² 988 / p 4e-217	45.2 EB05 31.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.0	no trial data cached
Colitis	23	53.6 36.3–79.1ROR 59.2 · χ² 1,137 / p 2e-249	51.4 EB05 36.1 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.3	no trial data cached
Frequent bowel movements	23	75.1 50.9–110.7ROR 82.9 · χ² 1,608 / p <1e-300	70.8 EB05 49.7 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 80.8	no trial data cached
Respiratory depression	22	157.7 105.8–234.9ROR 173.6 · χ² 3,266 / p <1e-300	138.7 EB05 96.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 113.2 · ♀ 27% (drug 65%)	no trial data cached
Vaginal discharge	22	192.6 129.2–286.9ROR 212.0 · χ² 3,996 / p <1e-300	164.9 EB05 114.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=22	no trial data cached
Brain oedema	13	90.4 53.3–153.4ROR 95.6 · χ² 1,061 / p 4e-233	80.1 EB05 49.8 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.7	no trial data cached
Pulmonary congestion	7	46.4 22.4–96.3ROR 47.8 · χ² 267 / p 2e-60	41.5 EB05 21.5 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.7	no trial data cached
Neutrophil count increased	6	51.2 23.2–112.9ROR 52.5 · χ² 247 / p 5e-56	44.4 EB05 21.7 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 39.3	no trial data cached
Arteriosclerosis	6	55.9 25.3–123.1ROR 57.3 · χ² 271 / p 4e-61	47.8 EB05 23.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Dimethyl Sulfoxide?

In FDA FAERS, the most frequently co-reported reaction terms for Dimethyl Sulfoxide are paraesthesia oral, macular degeneration, haematochezia, procedural pain, oral candidiasis, colitis ulcerative. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Dimethyl Sulfoxide have an FDA boxed warning?

No. The FDA label retrieved for Dimethyl Sulfoxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dimethyl Sulfoxide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 8f699de6-9d09-48da-9d95-4001d7008587, effective 20260720; matched on openfda.generic_name.exact:"DIMETHYL SULFOXIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 16 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.