Drug · FAERS side-effect profile with label screen
Medicinal Massage Oil side effects: what 212 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Allantoin
openFDA label
Who reports
212 reports · 98% serious · 179 with death outcome · 8% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin. Helps prevent and protect from the drying of wind and cold weather
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 40 strongest signals
Reporting / coding artifact 5Lab value / disease marker 2No label text to screen 33
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. 12 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 121 | 1,304.6 1,158.7–1,468.8ROR 3,037.9 · χ² 154,318 / p <1e-300 | 1,068.0 EB05 917.6 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 766.1 · 96% clinician | no trial data cached |
| Ventricular fibrillation | 121 | 1,086.4 965.3–1,222.8ROR 2,529.6 · χ² 128,766 / p <1e-300 | 917.3 EB05 788.1 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 631.6 · 96% clinician | no trial data cached |
| Cardiogenic shock | 117 | 817.7 723.5–924.2ROR 1,823.5 · χ² 93,899 / p <1e-300 | 715.3 EB05 613.0 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 475.3 · 96% clinician | no trial data cached |
| Bacterial infection | 100 | 535.4 464.0–617.9ROR 1,012.6 · χ² 52,570 / p <1e-300 | 483.1 EB05 408.7 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 361.0 · 96% clinician | no trial data cached |
| Incorrect route of product administration | 89 | 526.6 449.2–617.4ROR 906.9 · χ² 45,955 / p <1e-300 | 470.6 EB05 394.1 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious PRR 614.1 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 135 | 480.8 434.1–532.7ROR 1,322.1 · χ² 63,935 / p <1e-300 | 448.0 EB05 388.1 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 280.4 · 96% clinician | no trial data cached |
| Hyperlipidaemia | 55 | 455.9 362.9–572.8ROR 615.3 · χ² 24,414 / p <1e-300 | 391.8 EB05 312.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 293.3 · 95% clinician | no trial data cached |
| Neuralgia | 104 | 426.0 371.1–488.9ROR 835.2 · χ² 43,529 / p <1e-300 | 393.3 EB05 333.9 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 369.4 · 96% clinician | no trial data cached |
| Ascites | 121 | 408.5 363.3–459.4ROR 950.4 · χ² 48,649 / p <1e-300 | 382.2 EB05 328.4 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 242.1 · 96% clinician | no trial data cached |
| Ulcer | 57 | 355.1 284.3–443.6ROR 485.3 · χ² 19,718 / p <1e-300 | 316.2 EB05 253.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 261.9 · 95% clinician | no trial data cached |
| Blood test abnormal | 49 | 346.4 270.8–443.0ROR 450.2 · χ² 16,485 / p <1e-300 | 304.2 EB05 239.2 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 310.1 · 96% clinician | no trial data cached |
| Gout | 58 | 320.3 257.1–399.1ROR 440.6 · χ² 18,102 / p <1e-300 | 288.9 EB05 231.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 283.1 · 97% clinician | no trial data cached |
| Aspiration | 34 | 311.4 228.7–423.9ROR 370.7 · χ² 10,183 / p <1e-300 | 264.3 EB05 197.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 187.1 · 97% clinician | no trial data cached |
| End stage renal disease | 57 | 307.0 245.8–383.5ROR 419.6 · χ² 17,043 / p <1e-300 | 277.6 EB05 222.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.4 · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 27 | 279.9 196.6–398.3ROR 320.6 · χ² 7,209 / p <1e-300 | 233.2 EB05 168.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 174.1 · 96% clinician | no trial data cached |
| Full blood count abnormal | 29 | 272.8 194.4–382.7ROR 315.8 · χ² 7,566 / p <1e-300 | 230.8 EB05 168.5 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 212.0 · 97% clinician | no trial data cached |
| Micturition urgency | 29 | 253.6 180.8–355.9ROR 293.7 · χ² 7,033 / p <1e-300 | 217.0 EB05 158.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 245.6 · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 136 | 239.9 216.9–265.4ROR 667.4 · χ² 32,124 / p <1e-300 | 231.5 EB05 200.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 144.0 · 96% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 104 | 197.7 172.3–226.8ROR 387.1 · χ² 20,166 / p <1e-300 | 190.4 EB05 161.6 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 135.1 · 96% clinician | no trial data cached |
| Blood cholesterol increased | 90 | 191.2 163.4–223.7ROR 331.6 · χ² 16,846 / p <1e-300 | 183.5 EB05 153.8 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 169.9 · 97% clinician | no trial data cached |
| Stress | 134 | 184.6 166.6–204.6ROR 500.1 · χ² 24,326 / p <1e-300 | 179.6 EB05 155.5 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.3 · 96% clinician | no trial data cached |
| Transaminases increased | 33 | 147.1 107.5–201.4ROR 174.1 · χ² 4,643 / p <1e-300 | 135.6 EB05 101.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.0 · 94% clinician | no trial data cached |
| Joint injury | 31 | 143.6 103.7–198.8ROR 168.0 · χ² 4,246 / p <1e-300 | 131.9 EB05 97.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 109.1 · 97% clinician | no trial data cached |
| Dry mouth | 116 | 141.9 125.5–160.4ROR 312.1 · χ² 16,124 / p <1e-300 | 138.5 EB05 118.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.9 · 96% clinician | no trial data cached |
| Diabetes mellitus | 108 | 139.7 122.4–159.4ROR 283.7 · χ² 14,766 / p <1e-300 | 136.2 EB05 116.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.9 · 96% clinician | no trial data cached |
| Thrombosis | 105 | 128.9 112.5–147.7ROR 254.4 · χ² 13,230 / p <1e-300 | 125.8 EB05 106.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.3 · 96% clinician | no trial data cached |
| Sleep disorder | 91 | 128.8 110.3–150.5ROR 224.9 · χ² 11,435 / p <1e-300 | 125.3 EB05 105.1 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.5 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 136 | 120.7 109.1–133.5ROR 334.9 · χ² 16,089 / p <1e-300 | 118.6 EB05 102.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.1 · 93% clinician | no trial data cached |
| Iron deficiency anaemia | 11 | 118.6 66.7–210.9ROR 125.0 · χ² 1,166 / p 6e-256 | 98.7 EB05 58.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.6 | no trial data cached |
| Abdominal distension (bloating) | 124 | 118.1 105.4–132.3ROR 283.1 · χ² 14,335 / p <1e-300 | 115.9 EB05 99.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.1 · 96% clinician | no trial data cached |
| General physical health deterioration | 137 | 118.1 106.9–130.5ROR 332.0 · χ² 15,857 / p <1e-300 | 116.1 EB05 100.7 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 80.9 · 96% clinician | no trial data cached |
| Sputum discoloured | 11 | 115.2 64.8–204.9ROR 121.5 · χ² 1,133 / p 1e-248 | 96.4 EB05 57.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.4 | no trial data cached |
| Intentional product misuse | 101 | 115.1 100.0–132.6ROR 219.0 · χ² 11,348 / p <1e-300 | 112.6 EB05 95.4 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 153.3 · 96% clinician | no trial data cached |
| Lower respiratory tract infection | 51 | 111.4 87.7–141.6ROR 146.4 · χ² 5,477 / p <1e-300 | 106.9 EB05 84.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.1 · 94% clinician | no trial data cached |
| Swelling | 105 | 111.3 97.2–127.6ROR 219.6 · χ² 11,409 / p <1e-300 | 109.1 EB05 92.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.9 · 96% clinician | no trial data cached |
| Drug intolerance | 108 | 111.1 97.3–126.8ROR 225.5 · χ² 11,716 / p <1e-300 | 108.9 EB05 92.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 106.2 · 95% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 104 | 107.9 94.0–123.7ROR 210.8 · χ² 10,942 / p <1e-300 | 105.7 EB05 89.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.5 · 96% clinician | no trial data cached |
| Cardiovascular disorder | 27 | 104.5 73.5–148.7ROR 119.6 · χ² 2,666 / p <1e-300 | 97.4 EB05 70.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.9 · 96% clinician | no trial data cached |
| Coronary artery disease | 32 | 103.8 75.4–142.9ROR 122.1 · χ² 3,158 / p <1e-300 | 97.8 EB05 72.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.9 · 97% clinician | no trial data cached |
| Obstructive airways disorder | 11 | 97.6 54.9–173.5ROR 102.8 · χ² 956 / p 3e-210 | 83.8 EB05 49.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.5 | 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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 137 | 118.1 106.9–130.5ROR 332.0 · χ² 15,857 / p <1e-300 | 116.1 EB05 100.7 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 80.9 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 136 | 120.7 109.1–133.5ROR 334.9 · χ² 16,089 / p <1e-300 | 118.6 EB05 102.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.1 · 93% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 136 | 239.9 216.9–265.4ROR 667.4 · χ² 32,124 / p <1e-300 | 231.5 EB05 200.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 144.0 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 135 | 480.8 434.1–532.7ROR 1,322.1 · χ² 63,935 / p <1e-300 | 448.0 EB05 388.1 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 280.4 · 96% clinician | no trial data cached |
| Somnolence (drowsiness) | 134 | 66.0 59.5–73.1ROR 177.6 · χ² 8,586 / p <1e-300 | 65.3 EB05 56.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.0 · 96% clinician | no trial data cached |
| Stress | 134 | 184.6 166.6–204.6ROR 500.1 · χ² 24,326 / p <1e-300 | 179.6 EB05 155.5 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.3 · 96% clinician | no trial data cached |
| Abdominal distension (bloating) | 124 | 118.1 105.4–132.3ROR 283.1 · χ² 14,335 / p <1e-300 | 115.9 EB05 99.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.1 · 96% clinician | no trial data cached |
| Ascites | 121 | 408.5 363.3–459.4ROR 950.4 · χ² 48,649 / p <1e-300 | 382.2 EB05 328.4 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 242.1 · 96% clinician | no trial data cached |
| Ventricular fibrillation | 121 | 1,086.4 965.3–1,222.8ROR 2,529.6 · χ² 128,766 / p <1e-300 | 917.3 EB05 788.1 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 631.6 · 96% clinician | no trial data cached |
| Appendicitis | 121 | 1,304.6 1,158.7–1,468.8ROR 3,037.9 · χ² 154,318 / p <1e-300 | 1,068.0 EB05 917.6 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 766.1 · 96% clinician | no trial data cached |
| Cardiogenic shock | 117 | 817.7 723.5–924.2ROR 1,823.5 · χ² 93,899 / p <1e-300 | 715.3 EB05 613.0 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 475.3 · 96% clinician | no trial data cached |
| Dry mouth | 116 | 141.9 125.5–160.4ROR 312.1 · χ² 16,124 / p <1e-300 | 138.5 EB05 118.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 164.9 · 96% clinician | no trial data cached |
| Drug intolerance | 108 | 111.1 97.3–126.8ROR 225.5 · χ² 11,716 / p <1e-300 | 108.9 EB05 92.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 106.2 · 95% clinician | no trial data cached |
| Diabetes mellitus | 108 | 139.7 122.4–159.4ROR 283.7 · χ² 14,766 / p <1e-300 | 136.2 EB05 116.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.9 · 96% clinician | no trial data cached |
| Drug hypersensitivity | 107 | 54.5 47.7–62.3ROR 109.1 · χ² 5,617 / p <1e-300 | 54.0 EB05 45.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.4 · 96% clinician | 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 Medicinal Massage Oil?
In FDA FAERS, the most frequently co-reported reaction terms for Medicinal Massage Oil are sepsis, hyponatraemia, multiple organ dysfunction syndrome, somnolence, stress, abdominal distension. 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 Medicinal Massage Oil have an FDA boxed warning?
No. The FDA label retrieved for Medicinal Massage Oil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Medicinal Massage Oil 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 04b5619b-2122-f159-e063-6394a90a2e05, effective 20250115; matched on
openfda.generic_name.exact:"MEDICINAL MASSAGE OIL") - 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, 52 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.