Drug · FAERS side-effect profile with label screen
Ethyl Alcohol side effects: what 27,242 FDA adverse event reports show
Drug class
Not stated in label
Who reports
27,242 reports · 95% serious · 15,216 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• To decrease bacteria on the skin that could cause disease. • When water, soap and towel are not available. • Recommended for repeated use.
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 4Lab value / disease marker 6Outcome field, not a reaction 1No label text to screen 29
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 1,047 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 |
|---|---|---|---|---|---|---|
| Ex-drug abuser | 13 | 710.5 334.0–1,511.3ROR 710.8 · χ² 4,414 / p <1e-300 | 239.4 EB05 148.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial arm names this drug |
| Blood ethanol | 18 | 573.8 311.5–1,057.2ROR 574.2 · χ² 5,559 / p <1e-300 | 243.6 EB05 163.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Postmortem blood drug level | 21 | 422.8 248.2–720.4ROR 423.2 · χ² 5,423 / p <1e-300 | 218.6 EB05 150.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial arm names this drug |
| Alcohol interaction | 574 | 325.1 295.0–358.2ROR 332.1 · χ² 129,934 / p <1e-300 | 226.7 EB05 211.6 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=510 | no trial arm names this drug |
| Alcohol test positive | 13 | 292.5 154.4–554.3ROR 292.7 · χ² 2,525 / p <1e-300 | 162.0 EB05 100.7 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Victim of crime | 319 | 287.1 252.6–326.4ROR 290.6 · χ² 65,935 / p <1e-300 | 206.5 EB05 188.2 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=319 · ♀ 92% (drug 45%) · 95% clinician | no trial arm names this drug |
| Postmortem blood drug level abnormal | 36 | 252.7 173.4–368.3ROR 253.0 · χ² 6,596 / p <1e-300 | 172.9 EB05 130.5 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=36 · ♀ 68% (drug 45%) | no trial arm names this drug |
| Chemical submission | 58 | 238.6 177.7–320.3ROR 239.1 · χ² 10,280 / p <1e-300 | 171.9 EB05 137.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 88% (drug 45%) · 100% clinician | no trial arm names this drug |
| Behavioural addiction | 14 | 223.2 123.1–404.7ROR 223.3 · χ² 2,228 / p <1e-300 | 140.3 EB05 88.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial arm names this drug |
| Alcohol abuse | 512 | 182.4 165.7–200.7ROR 185.9 · χ² 74,440 / p <1e-300 | 146.7 EB05 136.3 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=436 | no trial arm names this drug |
| Foetal alcohol syndrome | 18 | 168.0 100.9–279.7ROR 168.1 · χ² 2,314 / p <1e-300 | 120.6 EB05 80.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial arm names this drug |
| Alcohol poisoning | 437 | 153.2 138.4–169.7ROR 155.7 · χ² 54,944 / p <1e-300 | 127.1 EB05 117.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=428 | no trial arm names this drug |
| Blood alcohol increased | 120 | 139.3 114.7–169.2ROR 139.9 · χ² 13,825 / p <1e-300 | 115.9 EB05 99.5 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=115 | no trial arm names this drug |
| Substance use disorder | 418 | 122.2 110.3–135.4ROR 124.1 · χ² 43,217 / p <1e-300 | 105.0 EB05 96.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=418 · 93% clinician | no trial arm names this drug |
| Blood ethanol increased | 30 | 120.8 82.2–177.5ROR 120.9 · χ² 2,976 / p <1e-300 | 98.1 EB05 72.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=30 | no trial arm names this drug |
| Polysubstance dependence | 23 | 119.7 77.1–185.8ROR 119.8 · χ² 2,240 / p <1e-300 | 95.6 EB05 67.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | no trial arm names this drug |
| Suspected suicide | 608 | 113.5 104.3–123.5ROR 116.1 · χ² 58,962 / p <1e-300 | 98.7 EB05 92.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=608 · 99% clinician | no trial arm names this drug |
| Substance dependence | 83 | 109.9 87.3–138.2ROR 110.2 · χ² 7,735 / p <1e-300 | 94.2 EB05 78.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=83 · 86% consumer | no trial arm names this drug |
| Victim of sexual abuse | 61 | 103.7 79.4–135.5ROR 103.9 · χ² 5,374 / p <1e-300 | 89.0 EB05 71.8 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=57 · ♀ 100% (drug 45%) | no trial arm names this drug |
| Illicit prescription attainment | 12 | 98.7 54.1–180.1ROR 98.8 · χ² 943 / p 2e-207 | 77.2 EB05 47.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial arm names this drug |
| Exposure to toxic agent | 336 | 90.4 80.8–101.1ROR 91.5 · χ² 26,489 / p <1e-300 | 80.6 EB05 73.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=336 · 100% clinician | no trial arm names this drug |
| Substance abuse | 834 | 88.4 82.4–94.9ROR 91.2 · χ² 64,577 / p <1e-300 | 79.2 EB05 74.8 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 52.1 | no trial arm names this drug |
| Alcoholic | 19 | 81.2 50.6–130.3ROR 81.3 · χ² 1,289 / p 1e-282 | 68.7 EB05 46.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial arm names this drug |
| Hanging | 16 | 74.2 44.4–123.9ROR 74.2 · χ² 987 / p 5e-217 | 62.9 EB05 41.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial arm names this drug |
| Alcohol withdrawal syndrome | 72 | 69.4 54.5–88.3ROR 69.6 · χ² 4,387 / p <1e-300 | 62.7 EB05 51.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=72 | no trial arm names this drug |
| Alcohol use disorder | 13 | 67.7 38.4–119.3ROR 67.7 · χ² 724 / p 8e-160 | 57.3 EB05 35.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial arm names this drug |
| Adulterated product | 15 | 65.6 38.7–111.1ROR 65.6 · χ² 820 / p 1e-180 | 56.4 EB05 36.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial arm names this drug |
| Postmortem blood drug level increased | 28 | 64.9 44.1–95.5ROR 65.0 · χ² 1,566 / p <1e-300 | 57.7 EB05 41.9 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 16% (drug 45%) · 100% clinician | no trial arm names this drug |
| Induced abortion failed | 10 | 63.2 33.2–120.5ROR 63.3 · χ² 510 / p 4e-113 | 52.9 EB05 30.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial arm names this drug |
| Alcohol use | 279 | 62.8 55.7–71.0ROR 63.5 · χ² 15,636 / p <1e-300 | 57.9 EB05 52.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=258 | no trial arm names this drug |
| Homicide | 131 | 60.7 50.8–72.5ROR 61.0 · χ² 7,073 / p <1e-300 | 55.9 EB05 48.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=123 · 78% consumer | no trial arm names this drug |
| Opiates positive | 35 | 60.4 42.9–85.3ROR 60.5 · χ² 1,842 / p <1e-300 | 54.5 EB05 41.0 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=35 · 91% clinician | no trial arm names this drug |
| Alcohol problem | 16 | 54.2 32.6–89.9ROR 54.2 · χ² 731 / p 3e-161 | 47.9 EB05 31.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial arm names this drug |
| Completed suicide (death by suicide) | 5,452 | 53.8 52.5–55.1ROR 67.1 · χ² 264,806 / p <1e-300 | 50.3 EB05 49.2 · IC025 +5.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 30.2 · 98% clinician | no trial arm names this drug |
| Drug abuse | 5,334 | 52.9 51.5–54.2ROR 65.6 · χ² 254,780 / p <1e-300 | 49.5 EB05 48.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · 91% clinician | no trial arm names this drug |
| Labelled drug-food interaction issue | 10 | 51.7 27.3–98.1ROR 51.7 · χ² 419 / p 2e-93 | 44.7 EB05 25.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial arm names this drug |
| Victim of homicide | 35 | 51.2 36.4–72.1ROR 51.3 · χ² 1,568 / p <1e-300 | 46.9 EB05 35.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 100% consumer | no trial arm names this drug |
| Victim of chemical submission | 36 | 50.7 36.2–71.1ROR 50.8 · χ² 1,599 / p <1e-300 | 46.5 EB05 35.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 76% (drug 45%) · 100% clinician | no trial arm names this drug |
| Child neglect | 13 | 50.2 28.7–88.0ROR 50.3 · χ² 543 / p 2e-120 | 44.4 EB05 27.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial arm names this drug |
| Alcohol intolerance | 42 | 49.0 35.9–66.9ROR 49.1 · χ² 1,811 / p <1e-300 | 45.2 EB05 34.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Ethyl Alcohol only as a background or rescue medication (NCT02726620, NCT03523962); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 6,038 | 28.9 28.3–29.6ROR 37.0 · χ² 158,227 / p <1e-300 | 27.9 EB05 27.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 · 92% clinician | no trial arm names this drug |
| Completed suicide (death by suicide) | 5,452 | 53.8 52.5–55.1ROR 67.1 · χ² 264,806 / p <1e-300 | 50.3 EB05 49.2 · IC025 +5.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 30.2 · 98% clinician | no trial arm names this drug |
| Drug abuse | 5,334 | 52.9 51.5–54.2ROR 65.6 · χ² 254,780 / p <1e-300 | 49.5 EB05 48.4 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · 91% clinician | no trial arm names this drug |
| Overdose | 1,914 | 6.9 6.6–7.2ROR 7.4 · χ² 9,687 / p <1e-300 | 6.8 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial arm names this drug |
| Death | 1,602 | 1.4 1.4–1.5ROR 1.5 · χ² 228 / p 8e-52 | 1.4 EB05 1.4 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 0.9 · 91% clinician | no trial arm names this drug |
| Intentional overdose | 1,561 | 19.5 18.5–20.4ROR 20.6 · χ² 26,731 / p <1e-300 | 19.0 EB05 18.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 | no trial arm names this drug |
| Suicide attempt | 1,360 | 17.8 16.8–18.7ROR 18.6 · χ² 21,060 / p <1e-300 | 17.4 EB05 16.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial arm names this drug |
| Cardio-respiratory arrest | 1,346 | 25.6 24.3–27.0ROR 26.9 · χ² 30,857 / p <1e-300 | 24.8 EB05 23.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 · 99% clinician | no trial arm names this drug |
| Somnolence (drowsiness) | 943 | 3.7 3.4–3.9ROR 3.8 · χ² 1,824 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial arm names this drug |
| Drug dependence | 919 | 4.4 4.1–4.7ROR 4.5 · χ² 2,421 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial arm names this drug |
| Drug interaction | 904 | 4.4 4.2–4.7ROR 4.6 · χ² 2,413 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial arm names this drug |
| Intentional product misuse | 856 | 7.7 7.2–8.2ROR 7.9 · χ² 4,969 / p <1e-300 | 7.6 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 | no trial arm names this drug |
| Coma | 855 | 14.2 13.2–15.1ROR 14.6 · χ² 10,279 / p <1e-300 | 13.9 EB05 13.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial arm names this drug |
| Substance abuse | 834 | 88.4 82.4–94.9ROR 91.2 · χ² 64,577 / p <1e-300 | 79.2 EB05 74.8 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 52.1 | no trial arm names this drug |
| Cardiac arrest (heart stopping) | 751 | 7.1 6.6–7.6ROR 7.3 · χ² 3,903 / p <1e-300 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 93% clinician | no trial arm names this drug |
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 Ethyl Alcohol?
In FDA FAERS, the most frequently co-reported reaction terms for Ethyl Alcohol are toxicity to various agents, suicide attempt, cardio-respiratory arrest, somnolence, coma, cardiac arrest. 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 Ethyl Alcohol have an FDA boxed warning?
No. The FDA label retrieved for Ethyl Alcohol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ethyl Alcohol 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 00583c24-de87-4488-9606-5fe9d3a3dea4, effective 20260702; matched on
openfda.generic_name.exact:"ETHYL ALCOHOL") - 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, 1,087 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 - ClinicalTrials.gov API v2 (query
ETHYL ALCOHOL, results-bearing studies sorted by enrollment)
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.