Drug · FAERS side-effect profile with label screen
Methyl Salicylate 10% side effects: what 218 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Methylten
openFDA label
Who reports
218 reports · 90% serious · 17 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of minor aches and pains of muscles and joints.
FDA label, Indications and Usage
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 19 strongest signals
Reporting / coding artifact 2Lab value / disease marker 1No label text to screen 16
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Urosepsis | 40 | 419.1 316.5–555.0ROR 513.1 · χ² 16,205 / p <1e-300 | 347.8 EB05 266.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 266.5 · ♀ 93% (drug 61%) · 92% clinician | no trial data cached |
| Pulmonary fibrosis | 28 | 141.1 99.8–199.5ROR 161.8 · χ² 3,754 / p <1e-300 | 128.7 EB05 93.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.7 · ♀ 90% (drug 61%) | no trial data cached |
| Synovitis | 26 | 138.8 96.7–199.1ROR 157.4 · χ² 3,417 / p <1e-300 | 125.9 EB05 90.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.5 · 96% clinician | no trial data cached |
| Ovarian cyst | 11 | 105.3 59.2–187.4ROR 110.8 · χ² 1,034 / p 4e-227 | 89.4 EB05 53.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.3 | no trial data cached |
| Red blood cell sedimentation rate increased | 11 | 95.5 53.7–169.9ROR 100.5 · χ² 936 / p 9e-206 | 82.2 EB05 49.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 68.9 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 39 | 85.1 64.0–113.1ROR 103.4 · χ² 3,160 / p <1e-300 | 81.7 EB05 62.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.3 · ♀ 96% (drug 61%) · 92% clinician | no trial data cached |
| Hypoaesthesia oral | 11 | 70.3 39.5–125.1ROR 74.0 · χ² 684 / p 5e-151 | 62.9 EB05 37.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.0 | no trial data cached |
| Contraindicated product administered | 20 | 63.8 42.0–96.9ROR 70.2 · χ² 1,176 / p 6e-258 | 60.3 EB05 41.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 50.6 · 95% clinician | no trial data cached |
| Loss of personal independence in daily activities | 28 | 56.7 40.1–80.1ROR 64.9 · χ² 1,478 / p <1e-300 | 54.6 EB05 39.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.5 | no trial data cached |
| Septic shock | 25 | 55.7 38.5–80.5ROR 62.8 · χ² 1,290 / p 9e-283 | 53.5 EB05 38.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · 96% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 52.1 30.1–90.3ROR 55.1 · χ² 552 / p 3e-122 | 48.3 EB05 29.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.9 | no trial data cached |
| Joint injury | 11 | 49.5 27.8–88.1ROR 52.1 · χ² 476 / p 1e-105 | 45.8 EB05 27.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 47.3 26.6–84.2ROR 49.8 · χ² 454 / p 5e-101 | 44.0 EB05 26.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.7 | no trial data cached |
| Arthropathy | 27 | 46.6 32.7–66.3ROR 53.0 · χ² 1,162 / p 7e-255 | 45.2 EB05 32.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.2 · 93% clinician | no trial data cached |
| Mood swings | 12 | 36.2 20.9–62.7ROR 38.2 · χ² 377 / p 3e-84 | 34.4 EB05 20.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.4 | no trial data cached |
| Rheumatoid arthritis | 40 | 34.0 25.7–45.0ROR 41.5 · χ² 1,256 / p 2e-275 | 33.5 EB05 25.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 100% (drug 61%) · 92% clinician | no trial data cached |
| Injection site pruritus | 23 | 33.3 22.6–48.9ROR 37.1 · χ² 690 / p 3e-152 | 32.4 EB05 22.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.3 · 96% clinician | no trial data cached |
| Eczema | 15 | 28.7 17.6–46.8ROR 30.7 · χ² 374 / p 1e-83 | 27.8 EB05 17.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.5 | no trial data cached |
| Drug dependence | 11 | 6.5 3.7–11.6ROR 6.8 · χ² 46 / p 5e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | 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 |
|---|---|---|---|---|---|---|
| Rheumatoid arthritis | 40 | 34.0 25.7–45.0ROR 41.5 · χ² 1,256 / p 2e-275 | 33.5 EB05 25.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 100% (drug 61%) · 92% clinician | no trial data cached |
| Urosepsis | 40 | 419.1 316.5–555.0ROR 513.1 · χ² 16,205 / p <1e-300 | 347.8 EB05 266.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 266.5 · ♀ 93% (drug 61%) · 92% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 39 | 85.1 64.0–113.1ROR 103.4 · χ² 3,160 / p <1e-300 | 81.7 EB05 62.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.3 · ♀ 96% (drug 61%) · 92% clinician | no trial data cached |
| Loss of personal independence in daily activities | 28 | 56.7 40.1–80.1ROR 64.9 · χ² 1,478 / p <1e-300 | 54.6 EB05 39.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.5 | no trial data cached |
| Pulmonary fibrosis | 28 | 141.1 99.8–199.5ROR 161.8 · χ² 3,754 / p <1e-300 | 128.7 EB05 93.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.7 · ♀ 90% (drug 61%) | no trial data cached |
| Arthropathy | 27 | 46.6 32.7–66.3ROR 53.0 · χ² 1,162 / p 7e-255 | 45.2 EB05 32.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.2 · 93% clinician | no trial data cached |
| Synovitis | 26 | 138.8 96.7–199.1ROR 157.4 · χ² 3,417 / p <1e-300 | 125.9 EB05 90.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.5 · 96% clinician | no trial data cached |
| Septic shock | 25 | 55.7 38.5–80.5ROR 62.8 · χ² 1,290 / p 9e-283 | 53.5 EB05 38.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · 96% clinician | no trial data cached |
| Injection site pruritus | 23 | 33.3 22.6–48.9ROR 37.1 · χ² 690 / p 3e-152 | 32.4 EB05 22.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.3 · 96% clinician | no trial data cached |
| Contraindicated product administered | 20 | 63.8 42.0–96.9ROR 70.2 · χ² 1,176 / p 6e-258 | 60.3 EB05 41.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 50.6 · 95% clinician | no trial data cached |
| Eczema | 15 | 28.7 17.6–46.8ROR 30.7 · χ² 374 / p 1e-83 | 27.8 EB05 17.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.5 | no trial data cached |
| Mood swings | 12 | 36.2 20.9–62.7ROR 38.2 · χ² 377 / p 3e-84 | 34.4 EB05 20.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.4 | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 52.1 30.1–90.3ROR 55.1 · χ² 552 / p 3e-122 | 48.3 EB05 29.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.9 | no trial data cached |
| Drug dependence | 11 | 6.5 3.7–11.6ROR 6.8 · χ² 46 / p 5e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 47.3 26.6–84.2ROR 49.8 · χ² 454 / p 5e-101 | 44.0 EB05 26.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.7 | 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 Methyl Salicylate 10%?
In FDA FAERS, the most frequently co-reported reaction terms for Methyl Salicylate 10% are rheumatoid arthritis, urosepsis, angioedema, loss of personal independence in daily activities, pulmonary fibrosis, arthropathy. 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 Methyl Salicylate 10% have an FDA boxed warning?
No. The FDA label retrieved for Methyl Salicylate 10% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methyl Salicylate 10% 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 28f4093f-803f-0e70-e063-6294a90a98a4, effective 20250113; matched on
openfda.generic_name.exact:"METHYL SALICYLATE 10%") - 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, fieldpatient.drug.openfda.generic_name.exact, 19 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.