Peppermint Oil side effects: what 1,087 FDA adverse event reports show
Drug class
Non-Standardized Plant Allergenic Extract, Non-Standardized Food Allergenic Extract
Who reports
1,087 reports · 78% serious · 37 with death outcome · 68% female
Used for
Uses ■For the effective treatment of mostnail fungus,athlete's foot,ringworm,and other skin fungus infections. ■Helps relieve symptoms such as discoloration,brittleness,thickened or crumbling nails.
Boxed warning
None in the current label
Causality screen of the 15 strongest signals
What the badges mean
- 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. 18 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 21 | 36.3 23.8–55.5ROR 37.0 · χ² 686 / p 2e-151 | 35.2 EB05 24.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 · ♀ 0% (drug 68%) | no trial data cached |
| Bronchospasm (airway tightening) | 24 | 32.4 21.8–48.1ROR 33.1 · χ² 698 / p 5e-154 | 31.6 EB05 22.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 · ♀ 22% (drug 68%) | no trial data cached |
| Secretion discharge | 17 | 26.6 16.6–42.6ROR 27.0 · χ² 393 / p 1e-87 | 25.8 EB05 17.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | no trial data cached |
| Pneumothorax | 21 | 25.6 16.7–39.1ROR 26.0 · χ² 471 / p 9e-105 | 25.0 EB05 17.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 · ♀ 0% (drug 68%) | no trial data cached |
| Eosinophilia | 21 | 23.2 15.2–35.4ROR 23.6 · χ² 424 / p 2e-94 | 22.7 EB05 15.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 0% (drug 68%) | no trial data cached |
| Myocarditis | 11 | 18.7 10.4–33.7ROR 18.9 · χ² 167 / p 1e-38 | 17.6 EB05 9.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.8 | no trial data cached |
| Incontinence | 10 | 18.2 9.8–33.8ROR 18.4 · χ² 146 / p 7e-34 | 16.9 EB05 8.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 | no trial data cached |
| Dyspnoea exertional | 27 | 13.9 9.6–20.1ROR 14.2 · χ² 310 / p 1e-69 | 13.4 EB05 9.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · ♀ 23% (drug 68%) | no trial data cached |
| Circulatory collapse | 12 | 13.5 7.7–23.8ROR 13.7 · χ² 127 / p 9e-30 | 12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Coronary artery disease | 21 | 13.3 8.7–20.3ROR 13.5 · χ² 226 / p 2e-51 | 12.6 EB05 8.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · ♀ 0% (drug 68%) | no trial data cached |
| Irritable bowel syndrome | 14 | 12.6 7.5–21.3ROR 12.8 · χ² 139 / p 3e-32 | 11.3 EB05 6.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Wheezing | 31 | 10.1 7.1–14.3ROR 10.4 · χ² 246 / p 1e-55 | 9.5 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 20% (drug 68%) | no trial data cached |
| Chest discomfort | 47 | 8.9 6.7–11.8ROR 9.2 · χ² 322 / p 2e-72 | 8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · ♀ 38% (drug 68%) | no trial data cached |
| Panic attack | 16 | 8.5 5.2–13.8ROR 8.6 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Flatulence (gas) | 23 | 7.8 5.2–11.7ROR 8.0 · χ² 131 / p 1e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 74% consumer | 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 |
|---|---|---|---|---|---|---|
| Chest discomfort | 47 | 8.9 6.7–11.8ROR 9.2 · χ² 322 / p 2e-72 | 8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · ♀ 38% (drug 68%) | no trial data cached |
| Wheezing | 31 | 10.1 7.1–14.3ROR 10.4 · χ² 246 / p 1e-55 | 9.5 EB05 6.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 20% (drug 68%) | no trial data cached |
| Dyspnoea exertional | 27 | 13.9 9.6–20.1ROR 14.2 · χ² 310 / p 1e-69 | 13.4 EB05 9.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · ♀ 23% (drug 68%) | no trial data cached |
| Bronchospasm (airway tightening) | 24 | 32.4 21.8–48.1ROR 33.1 · χ² 698 / p 5e-154 | 31.6 EB05 22.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 · ♀ 22% (drug 68%) | no trial data cached |
| Flatulence (gas) | 23 | 7.8 5.2–11.7ROR 8.0 · χ² 131 / p 1e-30 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · 74% consumer | no trial data cached |
| Coronary artery disease | 21 | 13.3 8.7–20.3ROR 13.5 · χ² 226 / p 2e-51 | 12.6 EB05 8.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · ♀ 0% (drug 68%) | no trial data cached |
| Eosinophilia | 21 | 23.2 15.2–35.4ROR 23.6 · χ² 424 / p 2e-94 | 22.7 EB05 15.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 0% (drug 68%) | no trial data cached |
| Pneumothorax | 21 | 25.6 16.7–39.1ROR 26.0 · χ² 471 / p 9e-105 | 25.0 EB05 17.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 · ♀ 0% (drug 68%) | no trial data cached |
| Obstructive airways disorder | 21 | 36.3 23.8–55.5ROR 37.0 · χ² 686 / p 2e-151 | 35.2 EB05 24.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.8 · ♀ 0% (drug 68%) | no trial data cached |
| Secretion discharge | 17 | 26.6 16.6–42.6ROR 27.0 · χ² 393 / p 1e-87 | 25.8 EB05 17.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | no trial data cached |
| Panic attack | 16 | 8.5 5.2–13.8ROR 8.6 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Irritable bowel syndrome | 14 | 12.6 7.5–21.3ROR 12.8 · χ² 139 / p 3e-32 | 11.3 EB05 6.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Circulatory collapse | 12 | 13.5 7.7–23.8ROR 13.7 · χ² 127 / p 9e-30 | 12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Myocarditis | 11 | 18.7 10.4–33.7ROR 18.9 · χ² 167 / p 1e-38 | 17.6 EB05 9.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.8 | no trial data cached |
| Incontinence | 10 | 18.2 9.8–33.8ROR 18.4 · χ² 146 / p 7e-34 | 16.9 EB05 8.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 | 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 Peppermint Oil?
In FDA FAERS, the most frequently co-reported reaction terms for Peppermint Oil are chest discomfort, wheezing, dyspnoea exertional, bronchospasm, flatulence, coronary artery disease. 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 Peppermint Oil have an FDA boxed warning?
No. The FDA label retrieved for Peppermint Oil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Peppermint 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 3e82649c-d784-d64c-e063-6294a90ac95d, effective 20250911; matched on
openfda.generic_name.exact:"PEPPERMINT 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, 33 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.