Drug · FAERS side-effect profile with label screen
Amish Origins Medicated side effects: what 989 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Menthol
openFDA label
Who reports
989 reports · 81% serious · 125 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome
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 2Lab value / disease marker 2No label text to screen 36
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. 30 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 36 | 80.1 58.1–110.4ROR 83.1 · χ² 2,723 / p <1e-300 | 76.6 EB05 57.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.0 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Joint dislocation | 23 | 46.4 31.0–69.5ROR 47.5 · χ² 975 / p 2e-214 | 44.7 EB05 31.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.9 · 91% clinician | no trial data cached |
| Dizziness postural | 20 | 44.2 28.7–68.3ROR 45.1 · χ² 801 / p 1e-176 | 42.5 EB05 29.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 62%) | no trial data cached |
| Helicobacter infection | 21 | 43.8 28.6–66.8ROR 44.7 · χ² 834 / p 1e-183 | 42.1 EB05 29.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.7 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Secretion discharge | 25 | 43.0 29.2–63.3ROR 44.1 · χ² 982 / p 7e-216 | 41.6 EB05 29.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 · ♀ 96% (drug 62%) | no trial data cached |
| Scratch | 20 | 41.0 26.6–63.3ROR 41.9 · χ² 741 / p 2e-163 | 39.5 EB05 27.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · ♀ 100% (drug 62%) | no trial data cached |
| Autoimmune disorder | 15 | 33.3 20.1–55.0ROR 33.8 · χ² 437 / p 2e-97 | 32.0 EB05 20.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.2 | no trial data cached |
| Hip arthroplasty | 22 | 30.8 20.3–46.5ROR 31.4 · χ² 604 / p 1e-133 | 30.0 EB05 20.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 · 91% clinician | no trial data cached |
| Irritable bowel syndrome | 29 | 28.8 20.1–41.2ROR 29.7 · χ² 751 / p 1e-165 | 28.3 EB05 20.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · 97% clinician | no trial data cached |
| Joint range of motion decreased | 18 | 28.6 18.1–45.2ROR 29.1 · χ² 452 / p 2e-100 | 27.8 EB05 18.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.8 | no trial data cached |
| Erythema multiforme | 12 | 27.3 15.6–48.0ROR 27.6 · χ² 278 / p 9e-63 | 26.2 EB05 15.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.0 | no trial data cached |
| Sciatica | 18 | 24.1 15.2–38.1ROR 24.5 · χ² 375 / p 6e-84 | 23.5 EB05 15.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 | no trial data cached |
| Folliculitis | 11 | 22.6 12.6–40.7ROR 22.8 · χ² 206 / p 5e-47 | 21.6 EB05 12.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 | no trial data cached |
| Prescribed overdose | 19 | 20.8 13.3–32.5ROR 21.2 · χ² 339 / p 5e-76 | 20.4 EB05 13.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.1 | no trial data cached |
| Fibromyalgia | 23 | 20.1 13.4–30.1ROR 20.5 · χ² 399 / p 6e-89 | 19.7 EB05 13.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.1 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Pemphigus | 11 | 18.8 10.4–33.8ROR 19.0 · χ² 168 / p 1e-38 | 17.7 EB05 9.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 | no trial data cached |
| Joint stiffness | 23 | 18.6 12.4–27.9ROR 19.0 · χ² 366 / p 8e-82 | 18.2 EB05 12.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 · 100% clinician | no trial data cached |
| C-reactive protein increased | 31 | 18.1 12.8–25.6ROR 18.6 · χ² 484 / p 2e-107 | 17.8 EB05 13.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.9 · ♀ 93% (drug 62%) · 97% clinician | no trial data cached |
| Lip swelling | 28 | 17.9 12.4–25.8ROR 18.4 · χ² 430 / p 9e-96 | 17.6 EB05 12.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 82% (drug 62%) · 100% clinician | no trial data cached |
| Hand deformity | 11 | 17.8 9.9–32.1ROR 18.0 · χ² 158 / p 1e-36 | 16.7 EB05 9.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 | no trial data cached |
| Bronchospasm (airway tightening) | 12 | 17.8 10.1–31.2ROR 18.0 · χ² 174 / p 6e-40 | 16.8 EB05 9.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Impaired healing | 27 | 17.4 12.0–25.3ROR 17.9 · χ² 403 / p 8e-90 | 17.2 EB05 12.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.9 · 96% clinician | no trial data cached |
| End stage renal disease | 15 | 17.3 10.5–28.6ROR 17.5 · χ² 214 / p 9e-49 | 16.6 EB05 10.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 | no trial data cached |
| Synovitis | 14 | 16.5 9.8–27.7ROR 16.7 · χ² 188 / p 4e-43 | 15.6 EB05 9.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 | no trial data cached |
| Hallucination, visual | 16 | 16.2 9.9–26.3ROR 16.4 · χ² 213 / p 2e-48 | 15.5 EB05 9.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 | no trial data cached |
| Pulmonary fibrosis | 14 | 15.5 9.2–26.1ROR 15.7 · χ² 176 / p 2e-40 | 14.6 EB05 8.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 | no trial data cached |
| Pericarditis | 12 | 15.3 8.7–26.8ROR 15.5 · χ² 146 / p 6e-34 | 14.0 EB05 7.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 | no trial data cached |
| Knee arthroplasty | 14 | 14.2 8.5–24.0ROR 14.4 · χ² 159 / p 7e-37 | 13.2 EB05 7.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 | no trial data cached |
| Liver injury | 16 | 14.0 8.6–22.8ROR 14.3 · χ² 181 / p 1e-41 | 13.1 EB05 7.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Type 2 diabetes mellitus | 22 | 13.8 9.1–20.9ROR 14.1 · χ² 249 / p 2e-56 | 13.2 EB05 8.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Blood cholesterol increased | 29 | 13.2 9.2–18.9ROR 13.6 · χ² 315 / p 8e-71 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · ♀ 96% (drug 62%) · 97% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 41 | 13.2 9.8–17.8ROR 13.7 · χ² 450 / p 4e-100 | 12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Osteoarthritis | 26 | 13.0 8.9–19.0ROR 13.3 · χ² 276 / p 3e-62 | 12.4 EB05 8.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 100% (drug 62%) · 92% clinician | no trial data cached |
| Prescribed underdose | 12 | 12.8 7.3–22.4ROR 12.9 · χ² 119 / p 6e-28 | 11.2 EB05 6.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial data cached |
| Tubulointerstitial nephritis | 11 | 12.5 6.9–22.4ROR 12.6 · χ² 105 / p 7e-25 | 10.7 EB05 5.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Haematoma | 15 | 12.2 7.4–20.2ROR 12.4 · χ² 144 / p 2e-33 | 11.0 EB05 6.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Lower limb fracture | 11 | 12.2 6.8–22.0ROR 12.3 · χ² 102 / p 2e-24 | 10.4 EB05 5.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Therapeutic product effect decreased | 25 | 11.9 8.1–17.6ROR 12.2 · χ² 240 / p 2e-54 | 11.3 EB05 7.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 16.0 · ♀ 95% (drug 62%) · 92% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 10.4 5.8–18.8ROR 10.5 · χ² 85 / p 2e-20 | 8.5 EB05 4.7 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Wound | 13 | 9.9 5.8–17.0ROR 10.0 · χ² 96 / p 7e-23 | 8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | 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 |
|---|---|---|---|---|---|---|
| Infusion related reaction (reaction during infusion) | 41 | 13.2 9.8–17.8ROR 13.7 · χ² 450 / p 4e-100 | 12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 36 | 80.1 58.1–110.4ROR 83.1 · χ² 2,723 / p <1e-300 | 76.6 EB05 57.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.0 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| C-reactive protein increased | 31 | 18.1 12.8–25.6ROR 18.6 · χ² 484 / p 2e-107 | 17.8 EB05 13.1 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.9 · ♀ 93% (drug 62%) · 97% clinician | no trial data cached |
| Blood cholesterol increased | 29 | 13.2 9.2–18.9ROR 13.6 · χ² 315 / p 8e-71 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · ♀ 96% (drug 62%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 29 | 28.8 20.1–41.2ROR 29.7 · χ² 751 / p 1e-165 | 28.3 EB05 20.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · 97% clinician | no trial data cached |
| Lip swelling | 28 | 17.9 12.4–25.8ROR 18.4 · χ² 430 / p 9e-96 | 17.6 EB05 12.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.2 · ♀ 82% (drug 62%) · 100% clinician | no trial data cached |
| Injury | 27 | 8.1 5.6–11.8ROR 8.3 · χ² 162 / p 3e-37 | 7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 96% clinician | no trial data cached |
| Impaired healing | 27 | 17.4 12.0–25.3ROR 17.9 · χ² 403 / p 8e-90 | 17.2 EB05 12.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.9 · 96% clinician | no trial data cached |
| Osteoarthritis | 26 | 13.0 8.9–19.0ROR 13.3 · χ² 276 / p 3e-62 | 12.4 EB05 8.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 100% (drug 62%) · 92% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 25 | 9.1 6.2–13.3ROR 9.3 · χ² 172 / p 2e-39 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · ♀ 92% (drug 62%) | no trial data cached |
| Therapeutic product effect decreased | 25 | 11.9 8.1–17.6ROR 12.2 · χ² 240 / p 2e-54 | 11.3 EB05 7.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 16.0 · ♀ 95% (drug 62%) · 92% clinician | no trial data cached |
| Secretion discharge | 25 | 43.0 29.2–63.3ROR 44.1 · χ² 982 / p 7e-216 | 41.6 EB05 29.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 · ♀ 96% (drug 62%) | no trial data cached |
| Joint stiffness | 23 | 18.6 12.4–27.9ROR 19.0 · χ² 366 / p 8e-82 | 18.2 EB05 12.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 · 100% clinician | no trial data cached |
| Fibromyalgia | 23 | 20.1 13.4–30.1ROR 20.5 · χ² 399 / p 6e-89 | 19.7 EB05 13.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.1 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Joint dislocation | 23 | 46.4 31.0–69.5ROR 47.5 · χ² 975 / p 2e-214 | 44.7 EB05 31.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.9 · 91% 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 Amish Origins Medicated?
In FDA FAERS, the most frequently co-reported reaction terms for Amish Origins Medicated are infusion related reaction, hypercholesterolaemia, c-reactive protein increased, blood cholesterol increased, irritable bowel syndrome, lip swelling. 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 Amish Origins Medicated have an FDA boxed warning?
No. The FDA label retrieved for Amish Origins Medicated has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amish Origins Medicated 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 547abe39-3af3-4d70-99dd-caf8d67feda2, effective 20241203; matched on
openfda.generic_name.exact:"AMISH ORIGINS MEDICATED") - 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, 70 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.