Drug · FAERS side-effect profile with label screen
Hamamelis Virginiana Root Bark/Stem Bark side effects: what 41 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Hamamelis Virginiana
openFDA label
Who reports
41 reports · 88% serious · 21 with death outcome · 88% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hemorrhoids With Bursting Sensation
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 25 strongest signals
Reporting / coding artifact 1No label text to screen 24
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.
- 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 17 | 910.2 632.3–1,310.2ROR 1,554.3 · χ² 14,525 / p <1e-300 | 448.3 EB05 296.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 633.2 | no trial data cached |
| Helicobacter infection | 17 | 854.1 593.4–1,229.5ROR 1,458.5 · χ² 13,629 / p <1e-300 | 434.3 EB05 287.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 590.9 | no trial data cached |
| Folliculitis | 16 | 793.3 540.8–1,163.7ROR 1,300.4 · χ² 11,868 / p <1e-300 | 406.2 EB05 265.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 610.4 | no trial data cached |
| Wound infection | 14 | 659.6 431.0–1,009.4ROR 1,001.0 · χ² 8,552 / p <1e-300 | 346.4 EB05 219.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 463.2 | no trial data cached |
| Hand deformity | 16 | 626.1 426.9–918.3ROR 1,026.2 · χ² 9,365 / p <1e-300 | 357.5 EB05 233.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 445.9 | no trial data cached |
| Pemphigus | 15 | 617.7 412.7–924.7ROR 973.6 · χ² 8,624 / p <1e-300 | 345.1 EB05 222.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 405.7 | no trial data cached |
| Joint range of motion decreased | 14 | 536.2 350.4–820.5ROR 813.7 · χ² 6,950 / p <1e-300 | 309.2 EB05 195.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 447.7 | no trial data cached |
| Pericarditis | 16 | 491.5 335.1–720.8ROR 805.4 · χ² 7,347 / p <1e-300 | 309.3 EB05 201.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 324.5 | no trial data cached |
| Back disorder | 14 | 438.9 286.8–671.5ROR 665.9 · χ² 5,686 / p <1e-300 | 274.3 EB05 173.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 414.3 | no trial data cached |
| Pulmonary fibrosis | 16 | 428.5 292.2–628.4ROR 702.1 · χ² 6,403 / p <1e-300 | 283.3 EB05 184.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 283.8 | no trial data cached |
| Hip arthroplasty | 12 | 404.4 251.2–651.1ROR 571.4 · χ² 4,434 / p <1e-300 | 246.1 EB05 150.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 273.3 | no trial data cached |
| Synovitis | 14 | 397.0 259.5–607.5ROR 602.3 · χ² 5,141 / p <1e-300 | 257.5 EB05 163.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 272.4 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 17 | 389.2 270.4–560.0ROR 664.1 · χ² 6,201 / p <1e-300 | 270.6 EB05 179.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 369.2 | no trial data cached |
| Irritable bowel syndrome | 15 | 359.3 240.0–537.7ROR 566.0 · χ² 5,008 / p <1e-300 | 246.5 EB05 158.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 298.9 | no trial data cached |
| Disability | 13 | 336.2 214.5–527.0ROR 491.9 · χ² 4,017 / p <1e-300 | 225.2 EB05 140.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 226.8 | no trial data cached |
| Liver injury | 15 | 317.4 212.1–475.1ROR 500.0 · χ² 4,423 / p <1e-300 | 226.1 EB05 145.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 215.7 | no trial data cached |
| Fibromyalgia | 15 | 316.0 211.2–473.0ROR 497.8 · χ² 4,403 / p <1e-300 | 225.4 EB05 145.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 272.5 | no trial data cached |
| Impaired healing | 19 | 296.1 212.9–411.7ROR 550.9 · χ² 5,302 / p <1e-300 | 228.2 EB05 154.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 210.0 | no trial data cached |
| Knee arthroplasty | 12 | 294.5 183.0–474.1ROR 415.9 · χ² 3,224 / p <1e-300 | 200.8 EB05 122.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 200.9 | no trial data cached |
| Gait inability | 16 | 247.3 168.7–362.7ROR 405.0 · χ² 3,687 / p <1e-300 | 191.1 EB05 124.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.7 | no trial data cached |
| Wound | 13 | 239.2 152.6–375.0ROR 349.8 · χ² 2,853 / p <1e-300 | 177.3 EB05 110.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.7 | no trial data cached |
| Type 2 diabetes mellitus | 15 | 227.2 151.8–340.1ROR 357.8 · χ² 3,160 / p <1e-300 | 176.5 EB05 113.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 156.9 | no trial data cached |
| Systemic lupus erythematosus | 15 | 216.9 145.0–324.6ROR 341.5 · χ² 3,016 / p <1e-300 | 170.2 EB05 109.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.9 | no trial data cached |
| Psoriatic arthropathy | 16 | 203.5 138.8–298.5ROR 333.2 · χ² 3,030 / p <1e-300 | 164.0 EB05 107.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.0 | no trial data cached |
| Ill-defined disorder | 20 | 168.3 123.0–230.3ROR 327.6 · χ² 3,169 / p <1e-300 | 145.2 EB05 99.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 166.3 · 100% clinician | 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 |
|---|---|---|---|---|---|---|
| Ill-defined disorder | 20 | 168.3 123.0–230.3ROR 327.6 · χ² 3,169 / p <1e-300 | 145.2 EB05 99.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 166.3 · 100% clinician | no trial data cached |
| Impaired healing | 19 | 296.1 212.9–411.7ROR 550.9 · χ² 5,302 / p <1e-300 | 228.2 EB05 154.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 210.0 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 17 | 389.2 270.4–560.0ROR 664.1 · χ² 6,201 / p <1e-300 | 270.6 EB05 179.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 369.2 | no trial data cached |
| Helicobacter infection | 17 | 854.1 593.4–1,229.5ROR 1,458.5 · χ² 13,629 / p <1e-300 | 434.3 EB05 287.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 590.9 | no trial data cached |
| Hypercholesterolaemia | 17 | 910.2 632.3–1,310.2ROR 1,554.3 · χ² 14,525 / p <1e-300 | 448.3 EB05 296.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 633.2 | no trial data cached |
| Psoriatic arthropathy | 16 | 203.5 138.8–298.5ROR 333.2 · χ² 3,030 / p <1e-300 | 164.0 EB05 107.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 168.0 | no trial data cached |
| Gait inability | 16 | 247.3 168.7–362.7ROR 405.0 · χ² 3,687 / p <1e-300 | 191.1 EB05 124.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.7 | no trial data cached |
| Pulmonary fibrosis | 16 | 428.5 292.2–628.4ROR 702.1 · χ² 6,403 / p <1e-300 | 283.3 EB05 184.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 283.8 | no trial data cached |
| Pericarditis | 16 | 491.5 335.1–720.8ROR 805.4 · χ² 7,347 / p <1e-300 | 309.3 EB05 201.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 324.5 | no trial data cached |
| Hand deformity | 16 | 626.1 426.9–918.3ROR 1,026.2 · χ² 9,365 / p <1e-300 | 357.5 EB05 233.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 445.9 | no trial data cached |
| Folliculitis | 16 | 793.3 540.8–1,163.7ROR 1,300.4 · χ² 11,868 / p <1e-300 | 406.2 EB05 265.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 610.4 | no trial data cached |
| Systemic lupus erythematosus | 15 | 216.9 145.0–324.6ROR 341.5 · χ² 3,016 / p <1e-300 | 170.2 EB05 109.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.9 | no trial data cached |
| Type 2 diabetes mellitus | 15 | 227.2 151.8–340.1ROR 357.8 · χ² 3,160 / p <1e-300 | 176.5 EB05 113.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 156.9 | no trial data cached |
| Fibromyalgia | 15 | 316.0 211.2–473.0ROR 497.8 · χ² 4,403 / p <1e-300 | 225.4 EB05 145.0 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 272.5 | no trial data cached |
| Liver injury | 15 | 317.4 212.1–475.1ROR 500.0 · χ² 4,423 / p <1e-300 | 226.1 EB05 145.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 215.7 | 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 Hamamelis Virginiana Root Bark/Stem Bark?
In FDA FAERS, the most frequently co-reported reaction terms for Hamamelis Virginiana Root Bark/Stem Bark are ill-defined disorder, glossodynia, helicobacter infection, hypercholesterolaemia, psoriatic arthropathy, gait inability. 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 Hamamelis Virginiana Root Bark/Stem Bark have an FDA boxed warning?
No. The FDA label retrieved for Hamamelis Virginiana Root Bark/Stem Bark has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hamamelis Virginiana Root Bark/Stem Bark 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 85a6be44-265c-2672-e053-2a91aa0ae0e2, effective 20231113; matched on
openfda.generic_name.exact:"HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK") - 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, 25 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.