Methyl Salicylate side effects: what 228 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Methyl Salicylate 10%
Who reports
228 reports · 89% serious · 17 with death outcome · 61% female
Used for
Temporarily relieves aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises
Boxed warning
None in the current label
Causality screen of the 19 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Urosepsis | 40 | 400.7 302.2–531.4ROR 485.8 · χ² 15,491 / p <1e-300 | 335.0 EB05 256.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 257.4 · ♀ 93% (drug 61%) · 92% clinician | no trial data cached |
| Pulmonary fibrosis | 28 | 134.9 95.3–190.9ROR 153.7 · χ² 3,587 / p <1e-300 | 123.6 EB05 89.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 87.6 · ♀ 90% (drug 61%) | no trial data cached |
| Synovitis | 26 | 132.7 92.4–190.6ROR 149.6 · χ² 3,265 / p <1e-300 | 120.9 EB05 86.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · 96% clinician | no trial data cached |
| Ovarian cyst | 11 | 100.7 56.6–179.3ROR 105.7 · χ² 988 / p 4e-217 | 86.0 EB05 51.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 75.6 | no trial data cached |
| Red blood cell sedimentation rate increased | 11 | 91.3 51.3–162.5ROR 95.9 · χ² 894 / p 1e-196 | 79.1 EB05 47.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 66.6 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 39 | 81.3 61.1–108.2ROR 97.9 · χ² 3,018 / p <1e-300 | 78.2 EB05 59.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 55.3 · ♀ 96% (drug 61%) · 92% clinician | no trial data cached |
| Hypoaesthesia oral | 11 | 67.2 37.8–119.7ROR 70.6 · χ² 653 / p 3e-144 | 60.5 EB05 36.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 79.2 | no trial data cached |
| Contraindicated product administered | 20 | 61.0 40.1–92.8ROR 66.8 · χ² 1,122 / p 2e-246 | 57.8 EB05 39.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 48.9 · 95% clinician | no trial data cached |
| Loss of personal independence in daily activities | 28 | 54.2 38.3–76.7ROR 61.6 · χ² 1,411 / p <1e-300 | 52.3 EB05 38.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 45.9 | no trial data cached |
| Septic shock | 25 | 53.2 36.8–77.1ROR 59.7 · χ² 1,231 / p 5e-270 | 51.2 EB05 36.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · 96% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 49.8 28.7–86.4ROR 52.5 · χ² 526 / p 8e-117 | 46.4 EB05 28.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 | no trial data cached |
| Joint injury | 11 | 47.3 26.6–84.3ROR 49.7 · χ² 454 / p 5e-101 | 44.0 EB05 26.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 45.3 25.4–80.6ROR 47.5 · χ² 433 / p 2e-96 | 42.2 EB05 25.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 42.2 | no trial data cached |
| Arthropathy | 27 | 44.5 31.2–63.5ROR 50.4 · χ² 1,108 / p 3e-243 | 43.3 EB05 31.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 · 93% clinician | no trial data cached |
| Mood swings | 12 | 34.6 19.9–60.0ROR 36.5 · χ² 359 / p 2e-80 | 32.9 EB05 20.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 39.0 | no trial data cached |
| Rheumatoid arthritis | 40 | 32.5 24.6–43.1ROR 39.3 · χ² 1,198 / p 1e-262 | 32.1 EB05 24.6 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.6 · ♀ 100% (drug 61%) · 92% clinician | no trial data cached |
| Injection site pruritus | 23 | 31.8 21.6–46.8ROR 35.2 · χ² 657 / p 3e-145 | 31.1 EB05 21.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 144.1 · 96% clinician | no trial data cached |
| Eczema | 15 | 27.4 16.8–44.7ROR 29.3 · χ² 357 / p 7e-80 | 26.6 EB05 17.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 51.7 | no trial data cached |
| Drug dependence | 11 | 6.2 3.5–11.1ROR 6.5 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 32.5 24.6–43.1ROR 39.3 · χ² 1,198 / p 1e-262 | 32.1 EB05 24.6 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.6 · ♀ 100% (drug 61%) · 92% clinician | no trial data cached |
| Urosepsis | 40 | 400.7 302.2–531.4ROR 485.8 · χ² 15,491 / p <1e-300 | 335.0 EB05 256.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 257.4 · ♀ 93% (drug 61%) · 92% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 39 | 81.3 61.1–108.2ROR 97.9 · χ² 3,018 / p <1e-300 | 78.2 EB05 59.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 55.3 · ♀ 96% (drug 61%) · 92% clinician | no trial data cached |
| Loss of personal independence in daily activities | 28 | 54.2 38.3–76.7ROR 61.6 · χ² 1,411 / p <1e-300 | 52.3 EB05 38.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 45.9 | no trial data cached |
| Pulmonary fibrosis | 28 | 134.9 95.3–190.9ROR 153.7 · χ² 3,587 / p <1e-300 | 123.6 EB05 89.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 87.6 · ♀ 90% (drug 61%) | no trial data cached |
| Arthropathy | 27 | 44.5 31.2–63.5ROR 50.4 · χ² 1,108 / p 3e-243 | 43.3 EB05 31.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 · 93% clinician | no trial data cached |
| Synovitis | 26 | 132.7 92.4–190.6ROR 149.6 · χ² 3,265 / p <1e-300 | 120.9 EB05 86.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · 96% clinician | no trial data cached |
| Septic shock | 25 | 53.2 36.8–77.1ROR 59.7 · χ² 1,231 / p 5e-270 | 51.2 EB05 36.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 34.2 · 96% clinician | no trial data cached |
| Injection site pruritus | 23 | 31.8 21.6–46.8ROR 35.2 · χ² 657 / p 3e-145 | 31.1 EB05 21.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 144.1 · 96% clinician | no trial data cached |
| Contraindicated product administered | 20 | 61.0 40.1–92.8ROR 66.8 · χ² 1,122 / p 2e-246 | 57.8 EB05 39.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 48.9 · 95% clinician | no trial data cached |
| Eczema | 15 | 27.4 16.8–44.7ROR 29.3 · χ² 357 / p 7e-80 | 26.6 EB05 17.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 51.7 | no trial data cached |
| Mood swings | 12 | 34.6 19.9–60.0ROR 36.5 · χ² 359 / p 2e-80 | 32.9 EB05 20.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 39.0 | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 49.8 28.7–86.4ROR 52.5 · χ² 526 / p 8e-117 | 46.4 EB05 28.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 | no trial data cached |
| Drug dependence | 11 | 6.2 3.5–11.1ROR 6.5 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 45.3 25.4–80.6ROR 47.5 · χ² 433 / p 2e-96 | 42.2 EB05 25.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 42.2 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Urosepsis — n=40, PRR 400.7
- Pulmonary fibrosis — n=28, PRR 134.9
- Synovitis — n=26, PRR 132.7
- Angioedema — n=39, PRR 81.3
- Loss of personal independence in daily activities — n=28, PRR 54.2
- Septic shock — n=25, PRR 53.2
- Arthropathy — n=27, PRR 44.5
- Injection site pruritus — n=23, PRR 31.8
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?
In FDA FAERS, the most frequently co-reported reaction terms for Methyl Salicylate 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 have an FDA boxed warning?
No. The FDA label retrieved for Methyl Salicylate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Methyl Salicylate 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 11a6d22a-1a7a-4c76-b873-fffd00ac4b54, effective 20260428; matched on
openfda.generic_name.exact:"METHYL SALICYLATE") - 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.