Drug · FAERS side-effect profile with label screen
Horse Chestnut side effects: what 307 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Aesculus Hippocastanum
openFDA label
Who reports
307 reports · 88% serious · 138 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
See symptoms on front panel. Relieves hemorrhoid pain aggravated by heat
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. 14 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 | 83 | 615.4 511.5–740.4ROR 843.0 · χ² 49,865 / p <1e-300 | 534.3 EB05 444.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 403.4 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 82 | 506.6 420.5–610.3ROR 690.9 · χ² 40,590 / p <1e-300 | 449.8 EB05 373.9 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 328.5 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 79 | 380.2 314.2–460.1ROR 511.6 · χ² 29,357 / p <1e-300 | 346.3 EB05 286.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 246.3 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 92 | 376.0 316.7–446.4ROR 536.4 · χ² 33,870 / p <1e-300 | 346.9 EB05 291.4 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious PRR 487.2 · ♀ 20% (drug 43%) · 97% clinician | no trial data cached |
| Hyperlipidaemia | 47 | 268.9 206.5–350.0ROR 317.3 · χ² 12,235 / p <1e-300 | 241.6 EB05 189.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 192.4 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Bacterial infection | 71 | 262.1 213.6–321.6ROR 340.7 · χ² 18,153 / p <1e-300 | 244.0 EB05 200.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 196.7 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 100 | 245.6 209.0–288.7ROR 363.8 · χ² 24,065 / p <1e-300 | 233.8 EB05 197.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 159.4 · ♀ 0% (drug 43%) · 97% clinician | no trial data cached |
| Blood test abnormal | 46 | 224.5 171.9–293.2ROR 263.9 · χ² 9,987 / p <1e-300 | 204.8 EB05 159.8 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 223.4 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Ulcer | 51 | 219.3 170.6–281.9ROR 262.8 · χ² 10,840 / p <1e-300 | 202.1 EB05 159.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 179.8 · ♀ 2% (drug 43%) · 92% clinician | no trial data cached |
| Aspiration | 34 | 215.0 156.5–295.4ROR 241.7 · χ² 7,012 / p <1e-300 | 191.4 EB05 143.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.6 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Neuralgia | 76 | 214.7 176.6–261.0ROR 285.0 · χ² 15,920 / p <1e-300 | 203.1 EB05 167.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 207.2 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Hypercholesterolaemia | 27 | 193.3 134.7–277.2ROR 211.8 · χ² 4,962 / p <1e-300 | 169.8 EB05 122.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 133.6 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Ascites | 83 | 193.3 160.8–232.3ROR 264.5 · χ² 15,661 / p <1e-300 | 184.6 EB05 153.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.5 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| End stage renal disease | 51 | 189.6 147.5–243.7ROR 227.2 · χ² 9,364 / p <1e-300 | 176.7 EB05 139.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 123.2 · ♀ 4% (drug 43%) · 94% clinician | no trial data cached |
| Full blood count abnormal | 29 | 188.4 133.2–266.5ROR 207.9 · χ² 5,207 / p <1e-300 | 167.3 EB05 122.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 162.7 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Gout | 49 | 186.8 144.4–241.6ROR 222.1 · χ² 8,853 / p <1e-300 | 173.8 EB05 136.6 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 183.6 · ♀ 0% (drug 43%) · 98% clinician | no trial data cached |
| Micturition urgency | 30 | 181.2 128.9–254.7ROR 200.7 · χ² 5,186 / p <1e-300 | 162.2 EB05 119.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 195.0 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Pneumonia aspiration | 51 | 140.1 109.0–180.0ROR 167.8 · χ² 6,897 / p <1e-300 | 132.9 EB05 105.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.4 · ♀ 100% (drug 43%) | no trial data cached |
| Hyponatraemia (low sodium) | 101 | 123.0 104.8–144.3ROR 182.7 · χ² 12,106 / p <1e-300 | 120.0 EB05 101.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.1 · ♀ 1% (drug 43%) · 97% clinician | no trial data cached |
| Transaminases increased | 33 | 101.6 73.6–140.3ROR 113.7 · χ² 3,186 / p <1e-300 | 96.0 EB05 71.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.6 · ♀ 3% (drug 43%) · 97% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 77 | 101.0 83.2–122.6ROR 134.5 · χ² 7,533 / p <1e-300 | 98.5 EB05 81.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 76.8 · ♀ 1% (drug 43%) · 96% clinician | no trial data cached |
| Joint injury | 31 | 99.2 71.0–138.5ROR 110.2 · χ² 2,913 / p <1e-300 | 93.5 EB05 69.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.8 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Stress | 102 | 97.0 82.8–113.7ROR 144.8 · χ² 9,614 / p <1e-300 | 95.2 EB05 80.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.8 · ♀ 3% (drug 43%) · 95% clinician | no trial data cached |
| Blood cholesterol increased | 64 | 93.9 75.5–116.7ROR 118.3 · χ² 5,792 / p <1e-300 | 91.2 EB05 74.0 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 92.7 · ♀ 3% (drug 43%) · 92% clinician | no trial data cached |
| Cardiovascular disorder | 29 | 77.5 54.8–109.6ROR 85.5 · χ² 2,115 / p <1e-300 | 73.8 EB05 53.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.5 · ♀ 4% (drug 43%) · 100% clinician | no trial data cached |
| Coma | 51 | 73.1 56.9–94.0ROR 87.5 · χ² 3,562 / p <1e-300 | 71.2 EB05 56.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.7 · ♀ 100% (drug 43%) | no trial data cached |
| Sleep disorder | 74 | 72.3 59.3–88.2ROR 95.0 · χ² 5,145 / p <1e-300 | 71.0 EB05 58.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.7 · ♀ 0% (drug 43%) · 95% clinician | no trial data cached |
| Coronary artery disease | 32 | 71.7 51.6–99.5ROR 79.9 · χ² 2,162 / p <1e-300 | 68.8 EB05 51.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.5 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Diabetes mellitus | 79 | 70.5 58.3–85.3ROR 94.6 · χ² 5,360 / p <1e-300 | 69.3 EB05 57.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · ♀ 0% (drug 43%) · 95% clinician | no trial data cached |
| Lower respiratory tract infection | 45 | 67.9 51.8–88.9ROR 79.4 · χ² 2,903 / p <1e-300 | 66.0 EB05 51.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.8 · ♀ 0% (drug 43%) · 93% clinician | no trial data cached |
| Thrombosis | 80 | 67.8 56.1–81.9ROR 91.3 · χ² 5,213 / p <1e-300 | 66.7 EB05 55.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.8 · ♀ 4% (drug 43%) · 92% clinician | no trial data cached |
| Dry mouth | 75 | 63.3 52.0–77.1ROR 83.5 · χ² 4,551 / p <1e-300 | 62.3 EB05 51.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.7 · ♀ 1% (drug 43%) · 92% clinician | no trial data cached |
| Sepsis (blood infection) | 102 | 62.5 53.3–73.2ROR 93.1 · χ² 6,137 / p <1e-300 | 61.7 EB05 52.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · ♀ 3% (drug 43%) · 95% clinician | no trial data cached |
| General physical health deterioration | 102 | 60.7 51.8–71.1ROR 90.4 · χ² 5,956 / p <1e-300 | 60.0 EB05 50.8 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 46.3 · ♀ 0% (drug 43%) · 97% clinician | no trial data cached |
| Intentional product misuse | 76 | 59.8 49.2–72.7ROR 79.2 · χ² 4,351 / p <1e-300 | 58.9 EB05 48.6 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 88.5 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 29 | 58.5 41.4–82.7ROR 64.5 · χ² 1,583 / p <1e-300 | 56.4 EB05 41.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.8 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Abdominal distension (bloating) | 88 | 57.9 48.5–69.0ROR 80.7 · χ² 4,880 / p <1e-300 | 57.1 EB05 47.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.5 · ♀ 2% (drug 43%) · 93% clinician | no trial data cached |
| Swelling | 77 | 56.4 46.5–68.4ROR 74.9 · χ² 4,147 / p <1e-300 | 55.6 EB05 45.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.6 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Drug intolerance | 78 | 55.4 45.7–67.1ROR 73.9 · χ² 4,128 / p <1e-300 | 54.7 EB05 45.2 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 58.1 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 76 | 54.4 44.8–66.1ROR 72.0 · χ² 3,947 / p <1e-300 | 53.7 EB05 44.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.6 · ♀ 1% (drug 43%) · 96% 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 |
|---|---|---|---|---|---|---|
| Somnolence (drowsiness) | 150 | 51.0 45.5–57.2ROR 98.8 · χ² 7,368 / p <1e-300 | 50.7 EB05 44.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.6 | no trial data cached |
| General physical health deterioration | 102 | 60.7 51.8–71.1ROR 90.4 · χ² 5,956 / p <1e-300 | 60.0 EB05 50.8 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 46.3 · ♀ 0% (drug 43%) · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 102 | 62.5 53.3–73.2ROR 93.1 · χ² 6,137 / p <1e-300 | 61.7 EB05 52.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · ♀ 3% (drug 43%) · 95% clinician | no trial data cached |
| Stress | 102 | 97.0 82.8–113.7ROR 144.8 · χ² 9,614 / p <1e-300 | 95.2 EB05 80.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.8 · ♀ 3% (drug 43%) · 95% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 101 | 123.0 104.8–144.3ROR 182.7 · χ² 12,106 / p <1e-300 | 120.0 EB05 101.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.1 · ♀ 1% (drug 43%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 100 | 245.6 209.0–288.7ROR 363.8 · χ² 24,065 / p <1e-300 | 233.8 EB05 197.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 159.4 · ♀ 0% (drug 43%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 92 | 376.0 316.7–446.4ROR 536.4 · χ² 33,870 / p <1e-300 | 346.9 EB05 291.4 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious PRR 487.2 · ♀ 20% (drug 43%) · 97% clinician | no trial data cached |
| Abdominal distension (bloating) | 88 | 57.9 48.5–69.0ROR 80.7 · χ² 4,880 / p <1e-300 | 57.1 EB05 47.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.5 · ♀ 2% (drug 43%) · 93% clinician | no trial data cached |
| Ascites | 83 | 193.3 160.8–232.3ROR 264.5 · χ² 15,661 / p <1e-300 | 184.6 EB05 153.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.5 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Appendicitis | 83 | 615.4 511.5–740.4ROR 843.0 · χ² 49,865 / p <1e-300 | 534.3 EB05 444.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 403.4 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 82 | 506.6 420.5–610.3ROR 690.9 · χ² 40,590 / p <1e-300 | 449.8 EB05 373.9 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 328.5 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Thrombosis | 80 | 67.8 56.1–81.9ROR 91.3 · χ² 5,213 / p <1e-300 | 66.7 EB05 55.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.8 · ♀ 4% (drug 43%) · 92% clinician | no trial data cached |
| Diabetes mellitus | 79 | 70.5 58.3–85.3ROR 94.6 · χ² 5,360 / p <1e-300 | 69.3 EB05 57.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · ♀ 0% (drug 43%) · 95% clinician | no trial data cached |
| Cardiogenic shock | 79 | 380.2 314.2–460.1ROR 511.6 · χ² 29,357 / p <1e-300 | 346.3 EB05 286.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 246.3 · ♀ 0% (drug 43%) · 96% clinician | no trial data cached |
| Drug hypersensitivity | 78 | 27.4 22.7–33.2ROR 36.4 · χ² 1,979 / p <1e-300 | 27.3 EB05 22.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.8 · ♀ 0% (drug 43%) · 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 Horse Chestnut?
In FDA FAERS, the most frequently co-reported reaction terms for Horse Chestnut are somnolence, sepsis, stress, hyponatraemia, multiple organ dysfunction syndrome, 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 Horse Chestnut have an FDA boxed warning?
No. The FDA label retrieved for Horse Chestnut has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Horse Chestnut 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 8410dc8b-382c-8f38-e053-2a91aa0a850d, effective 20250701; matched on
openfda.generic_name.exact:"HORSE CHESTNUT") - 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, 54 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.