Drug · FAERS side-effect profile with label screen
Asian Ginseng side effects: what 394 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Gim
openFDA label
Who reports
394 reports · 82% serious · 153 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Directions Directions: same as the above
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 1No label text to screen 37
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. 73 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 | 55 | 316.8 247.7–405.1ROR 368.0 · χ² 16,903 / p <1e-300 | 283.8 EB05 226.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 223.6 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Incorrect route of product administration | 88 | 280.1 232.9–337.0ROR 360.4 · χ² 24,090 / p <1e-300 | 262.8 EB05 219.8 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 389.8 · 99% clinician | no trial data cached |
| Ventricular fibrillation | 55 | 264.1 206.5–337.7ROR 306.8 · χ² 14,091 / p <1e-300 | 240.8 EB05 192.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 184.3 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Joint range of motion decreased | 66 | 264.1 211.8–329.3ROR 317.0 · χ² 16,961 / p <1e-300 | 244.2 EB05 198.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 234.5 · ♀ 100% (drug 57%) · 92% clinician | no trial data cached |
| Helicobacter infection | 47 | 246.5 188.3–322.5ROR 279.7 · χ² 11,199 / p <1e-300 | 223.1 EB05 174.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 181.5 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Pemphigus | 57 | 245.1 192.7–311.8ROR 286.4 · χ² 13,559 / p <1e-300 | 225.6 EB05 180.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 171.3 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Hand deformity | 59 | 241.1 190.4–305.2ROR 283.3 · χ² 13,811 / p <1e-300 | 222.7 EB05 179.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 182.7 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Synovitis | 79 | 234.0 192.0–285.1ROR 292.4 · χ² 18,029 / p <1e-300 | 220.5 EB05 182.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 170.8 · ♀ 100% (drug 57%) · 92% clinician | no trial data cached |
| Cardiogenic shock | 51 | 190.9 147.7–246.7ROR 219.1 · χ² 9,416 / p <1e-300 | 177.6 EB05 140.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 133.0 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Folliculitis | 28 | 144.6 101.2–206.8ROR 155.6 · χ² 3,843 / p <1e-300 | 131.5 EB05 95.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 118.7 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 60 | 143.2 113.4–180.8ROR 168.8 · χ² 8,317 / p <1e-300 | 136.7 EB05 110.0 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 144.8 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Pulmonary fibrosis | 47 | 131.2 100.3–171.6ROR 148.8 · χ² 5,933 / p <1e-300 | 124.4 EB05 97.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.6 · ♀ 89% (drug 57%) · 98% clinician | no trial data cached |
| Nephropathy | 23 | 130.7 87.9–194.5ROR 138.8 · χ² 2,827 / p <1e-300 | 117.9 EB05 82.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.3 · ♀ 100% (drug 57%) | no trial data cached |
| Back disorder | 39 | 127.4 94.6–171.7ROR 141.3 · χ² 4,758 / p <1e-300 | 119.8 EB05 91.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.2 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Prescribed overdose | 46 | 126.8 96.6–166.4ROR 143.4 · χ² 5,608 / p <1e-300 | 120.3 EB05 93.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 151.1 · ♀ 100% (drug 57%) · 96% clinician | no trial data cached |
| Bursitis | 28 | 123.8 86.6–177.0ROR 133.2 · χ² 3,283 / p <1e-300 | 114.1 EB05 82.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.8 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Bacterial infection | 43 | 123.5 93.1–163.8ROR 138.5 · χ² 5,096 / p <1e-300 | 116.9 EB05 90.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.6 · ♀ 3% (drug 57%) · 95% clinician | no trial data cached |
| Body height decreased | 23 | 113.5 76.3–168.7ROR 120.4 · χ² 2,448 / p <1e-300 | 103.7 EB05 72.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 57%) | no trial data cached |
| Prescribed underdose | 42 | 112.3 84.3–149.5ROR 125.6 · χ² 4,517 / p <1e-300 | 106.7 EB05 82.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.1 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 20 | 111.5 72.7–170.9ROR 117.4 · χ² 2,077 / p <1e-300 | 100.8 EB05 68.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.8 · 100% clinician | no trial data cached |
| Hyperlipidaemia | 25 | 111.2 76.1–162.6ROR 118.7 · χ² 2,618 / p <1e-300 | 102.5 EB05 73.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 85.6 · ♀ 0% (drug 57%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 58 | 110.8 87.4–140.6ROR 129.8 · χ² 6,199 / p <1e-300 | 106.8 EB05 85.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.3 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Wound | 55 | 105.5 82.5–134.8ROR 122.4 · χ² 5,584 / p <1e-300 | 101.6 EB05 81.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.8 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Lower limb fracture | 36 | 100.5 73.6–137.3ROR 110.5 · χ² 3,445 / p <1e-300 | 95.4 EB05 72.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.2 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Neuralgia | 45 | 98.9 75.1–130.3ROR 111.6 · χ² 4,262 / p <1e-300 | 94.9 EB05 73.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.6 · ♀ 3% (drug 57%) · 96% clinician | no trial data cached |
| Ascites | 54 | 97.9 76.4–125.4ROR 113.3 · χ² 5,079 / p <1e-300 | 94.5 EB05 75.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.4 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Sciatica | 29 | 97.5 68.6–138.4ROR 105.1 · χ² 2,671 / p <1e-300 | 91.6 EB05 66.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.6 · ♀ 100% (drug 57%) | no trial data cached |
| Obesity | 29 | 96.9 68.2–137.6ROR 104.5 · χ² 2,654 / p <1e-300 | 91.1 EB05 66.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.6 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Lower respiratory tract infection | 82 | 96.5 79.6–117.0ROR 121.6 · χ² 7,655 / p <1e-300 | 94.2 EB05 78.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.3 · 98% clinician | no trial data cached |
| Blood test abnormal | 25 | 94.9 64.9–138.8ROR 101.3 · χ² 2,228 / p <1e-300 | 88.5 EB05 63.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 101.6 · ♀ 0% (drug 57%) · 100% clinician | no trial data cached |
| Ulcer | 28 | 93.7 65.5–133.9ROR 100.8 · χ² 2,473 / p <1e-300 | 88.1 EB05 63.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.6 · ♀ 0% (drug 57%) · 96% clinician | no trial data cached |
| Foot deformity | 19 | 91.3 58.8–141.6ROR 95.8 · χ² 1,605 / p <1e-300 | 83.7 EB05 56.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.2 | no trial data cached |
| Pericarditis | 28 | 89.6 62.7–128.0ROR 96.3 · χ² 2,362 / p <1e-300 | 84.4 EB05 61.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.1 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Aspiration | 18 | 88.6 56.4–139.1ROR 92.8 · χ² 1,470 / p <1e-300 | 81.1 EB05 54.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.6 | no trial data cached |
| Fibromyalgia | 40 | 87.8 65.4–117.8ROR 97.6 · χ² 3,344 / p <1e-300 | 84.2 EB05 64.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.7 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Systemic lupus erythematosus | 58 | 87.4 68.9–110.9ROR 102.3 · χ² 4,868 / p <1e-300 | 84.9 EB05 68.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.7 · ♀ 100% (drug 57%) · 98% clinician | no trial data cached |
| Blood cholesterol increased | 74 | 84.6 68.9–103.9ROR 103.9 · χ² 6,032 / p <1e-300 | 82.7 EB05 68.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 89.7 · 99% clinician | no trial data cached |
| Liver injury | 38 | 83.8 61.9–113.3ROR 92.6 · χ² 3,024 / p <1e-300 | 80.4 EB05 61.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.7 · ♀ 100% (drug 57%) · 100% clinician | no trial data cached |
| Gout | 28 | 83.1 58.1–118.7ROR 89.3 · χ² 2,187 / p <1e-300 | 78.6 EB05 57.1 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.7 · ♀ 0% (drug 57%) · 100% clinician | no trial data cached |
| End stage renal disease | 28 | 81.0 56.7–115.8ROR 87.1 · χ² 2,132 / p <1e-300 | 76.8 EB05 55.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.6 · ♀ 0% (drug 57%) · 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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 111 | 51.5 44.0–60.3ROR 71.3 · χ² 5,468 / p <1e-300 | 51.0 EB05 43.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 42.1 · 98% clinician | no trial data cached |
| Drug hypersensitivity | 90 | 24.7 20.6–29.6ROR 31.7 · χ² 2,039 / p <1e-300 | 24.6 EB05 20.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.0 · 96% clinician | no trial data cached |
| Incorrect route of product administration | 88 | 280.1 232.9–337.0ROR 360.4 · χ² 24,090 / p <1e-300 | 262.8 EB05 219.8 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 389.8 · 99% clinician | no trial data cached |
| Drug intolerance | 87 | 48.1 40.0–58.0ROR 61.5 · χ² 3,984 / p <1e-300 | 47.6 EB05 39.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 54.9 · 97% clinician | no trial data cached |
| Hepatic enzyme increased | 85 | 66.6 55.2–80.5ROR 84.7 · χ² 5,442 / p <1e-300 | 65.6 EB05 54.7 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious PRR 67.5 · ♀ 100% (drug 57%) · 93% clinician | no trial data cached |
| Lower respiratory tract infection | 82 | 96.5 79.6–117.0ROR 121.6 · χ² 7,655 / p <1e-300 | 94.2 EB05 78.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.3 · 98% clinician | no trial data cached |
| Musculoskeletal stiffness | 81 | 49.2 40.5–59.8ROR 61.7 · χ² 3,790 / p <1e-300 | 48.6 EB05 40.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.6 · 91% clinician | no trial data cached |
| Dry mouth | 80 | 52.6 43.3–64.0ROR 65.8 · χ² 4,011 / p <1e-300 | 52.0 EB05 43.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.0 · ♀ 35% (drug 57%) · 99% clinician | no trial data cached |
| Arthropathy | 79 | 75.5 62.0–91.9ROR 94.2 · χ² 5,738 / p <1e-300 | 74.1 EB05 61.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.3 · ♀ 100% (drug 57%) · 91% clinician | no trial data cached |
| Synovitis | 79 | 234.0 192.0–285.1ROR 292.4 · χ² 18,029 / p <1e-300 | 220.5 EB05 182.7 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 170.8 · ♀ 100% (drug 57%) · 92% clinician | no trial data cached |
| Swelling | 78 | 44.5 36.5–54.3ROR 55.2 · χ² 3,284 / p <1e-300 | 44.0 EB05 36.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · 96% clinician | no trial data cached |
| Musculoskeletal pain | 74 | 74.7 60.8–91.7ROR 91.7 · χ² 5,311 / p <1e-300 | 73.2 EB05 60.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.4 · ♀ 100% (drug 57%) · 92% clinician | no trial data cached |
| Blood cholesterol increased | 74 | 84.6 68.9–103.9ROR 103.9 · χ² 6,032 / p <1e-300 | 82.7 EB05 68.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 89.7 · 99% clinician | no trial data cached |
| Diabetes mellitus | 70 | 48.7 39.4–60.2ROR 59.0 · χ² 3,231 / p <1e-300 | 48.1 EB05 39.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.0 · ♀ 35% (drug 57%) · 91% clinician | no trial data cached |
| Joint range of motion decreased | 66 | 264.1 211.8–329.3ROR 317.0 · χ² 16,961 / p <1e-300 | 244.2 EB05 198.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 234.5 · ♀ 100% (drug 57%) · 92% 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 Asian Ginseng?
In FDA FAERS, the most frequently co-reported reaction terms for Asian Ginseng are drug hypersensitivity, hepatic enzyme increased, lower respiratory tract infection, musculoskeletal stiffness, dry mouth, arthropathy. 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 Asian Ginseng have an FDA boxed warning?
No. The FDA label retrieved for Asian Ginseng has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Asian Ginseng 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 d00a37b9-4d58-40c4-a406-2522bc34d0ea, effective 20181128; matched on
openfda.generic_name.exact:"ASIAN GINSENG") - 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, 113 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.