Drug · FAERS side-effect profile with label screen
Ethanol side effects: what 7,974 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,974 reports · 99% serious · 6,941 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For handwashing to decrease bacteria on the skin
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 7Lab value / disease marker 6Outcome field, not a reaction 2No label text to screen 25
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. 492 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 |
|---|---|---|---|---|---|---|
| Blood ethanol increased | 26 | 347.7 231.0–523.2ROR 348.8 · χ² 7,622 / p <1e-300 | 250.3 EB05 179.5 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=25 · 96% clinician | no trial data cached |
| Environmental exposure | 23 | 285.5 185.7–438.8ROR 286.3 · χ² 5,620 / p <1e-300 | 212.1 EB05 148.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · 100% clinician | no trial data cached |
| Exposure via ingestion | 240 | 273.2 239.6–311.5ROR 281.6 · χ² 58,643 / p <1e-300 | 242.5 EB05 217.8 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=232 · 100% clinician | no trial data cached |
| Blood alcohol increased | 42 | 147.8 108.4–201.6ROR 148.6 · χ² 5,657 / p <1e-300 | 131.7 EB05 101.5 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=40 | no trial data cached |
| Poisoning | 616 | 135.0 124.9–145.9ROR 146.2 · χ² 77,795 / p <1e-300 | 127.9 EB05 119.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.6 · 99% clinician | no trial data cached |
| Alcohol poisoning | 116 | 120.2 99.9–144.6ROR 122.0 · χ² 12,995 / p <1e-300 | 112.8 EB05 96.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=116 | no trial data cached |
| Multiple drug overdose intentional | 116 | 96.9 80.6–116.5ROR 98.4 · χ² 10,527 / p <1e-300 | 92.1 EB05 78.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=116 · 100% clinician | no trial data cached |
| Alcohol use | 124 | 90.6 75.8–108.2ROR 92.0 · χ² 10,527 / p <1e-300 | 86.4 EB05 74.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=122 · 95% clinician | no trial data cached |
| Completed suicide (death by suicide) | 2,795 | 90.4 87.6–93.2ROR 138.6 · χ² 239,548 / p <1e-300 | 87.3 EB05 84.6 · IC025 +6.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 50.7 · 99% clinician | no trial data cached |
| Accidental death | 61 | 89.5 69.4–115.4ROR 90.2 · χ² 5,075 / p <1e-300 | 84.3 EB05 68.0 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=61 | no trial data cached |
| Multiple drug overdose | 159 | 85.7 73.3–100.3ROR 87.5 · χ² 12,813 / p <1e-300 | 82.2 EB05 72.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=159 · 98% clinician | no trial data cached |
| Multiple drug overdose accidental | 13 | 75.8 43.7–131.5ROR 75.9 · χ² 861 / p 2e-189 | 66.8 EB05 41.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Respiratory arrest | 762 | 74.1 69.2–79.3ROR 81.8 · χ² 53,405 / p <1e-300 | 71.9 EB05 67.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.1 · 99% clinician | no trial data cached |
| Drug toxicity | 362 | 70.8 63.9–78.4ROR 74.1 · χ² 24,183 / p <1e-300 | 68.7 EB05 62.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.9 · 93% clinician | no trial data cached |
| Intentional misuse | 45 | 62.6 46.6–84.0ROR 62.9 · χ² 2,602 / p <1e-300 | 59.6 EB05 46.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=43 · 93% clinician | no trial data cached |
| Intentional drug misuse | 415 | 52.5 47.7–57.7ROR 55.3 · χ² 20,509 / p <1e-300 | 51.3 EB05 47.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 53.5 · 99% clinician | no trial data cached |
| Drug abuse | 1,625 | 52.1 49.8–54.4ROR 65.2 · χ² 80,090 / p <1e-300 | 51.1 EB05 49.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · 99% clinician | no trial data cached |
| Cardio-respiratory arrest | 807 | 51.4 48.1–54.9ROR 57.1 · χ² 39,134 / p <1e-300 | 50.4 EB05 47.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · 100% clinician | no trial data cached |
| Alcohol interaction | 36 | 49.4 35.6–68.7ROR 49.7 · χ² 1,629 / p <1e-300 | 47.4 EB05 35.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 | no trial data cached |
| Blood ph decreased | 19 | 29.4 18.7–46.1ROR 29.4 · χ² 487 / p 3e-108 | 28.3 EB05 19.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Toxicity to various agents | 1,744 | 27.6 26.5–28.8ROR 35.1 · χ² 44,580 / p <1e-300 | 27.3 EB05 26.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · 98% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 841 | 27.0 25.3–28.7ROR 30.0 · χ² 20,860 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.5 · 99% clinician | no trial data cached |
| Pupil fixed | 16 | 24.3 14.9–39.8ROR 24.4 · χ² 332 / p 2e-74 | 23.5 EB05 15.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Blood bicarbonate decreased | 15 | 20.8 12.5–34.6ROR 20.9 · χ² 261 / p 4e-59 | 20.0 EB05 12.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Anion gap increased | 10 | 19.7 10.6–36.8ROR 19.8 · χ² 158 / p 1e-36 | 18.4 EB05 9.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Alcohol abuse | 20 | 19.7 12.7–30.5ROR 19.7 · χ² 333 / p 1e-74 | 19.1 EB05 12.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Self injurious behaviour | 22 | 18.8 12.4–28.6ROR 18.9 · χ² 351 / p 1e-78 | 18.3 EB05 12.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | no trial data cached |
| Poisoning deliberate | 62 | 17.6 13.7–22.6ROR 17.8 · χ² 950 / p 6e-209 | 17.4 EB05 14.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · 100% clinician | no trial data cached |
| Substance abuse | 52 | 16.9 12.9–22.1ROR 17.0 · χ² 756 / p 1e-166 | 16.6 EB05 13.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 | no trial data cached |
| Intentional overdose | 395 | 16.4 14.9–18.0ROR 17.2 · χ² 5,674 / p <1e-300 | 16.3 EB05 15.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 | no trial data cached |
| Drug abuser | 36 | 15.3 11.0–21.2ROR 15.3 · χ² 464 / p 4e-103 | 15.0 EB05 11.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 96% clinician | no trial data cached |
| Hepatic necrosis | 19 | 13.3 8.5–20.8ROR 13.3 · χ² 202 / p 3e-46 | 12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Electrocardiogram qrs complex prolonged | 25 | 12.9 8.7–19.1ROR 12.9 · χ² 262 / p 4e-59 | 12.3 EB05 8.4 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=25 · 90% clinician | no trial data cached |
| Excoriation | 11 | 11.3 6.2–20.4ROR 11.3 · χ² 93 / p 3e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Potentiating drug interaction | 14 | 11.3 6.7–19.0ROR 11.3 · χ² 120 / p 3e-28 | 9.8 EB05 5.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Brain death | 13 | 11.1 6.4–19.1ROR 11.1 · χ² 109 / p 1e-25 | 9.4 EB05 5.4 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious n=13 | no trial data cached |
| Pulmonary congestion | 53 | 10.6 8.1–13.8ROR 10.6 · χ² 448 / p 1e-99 | 10.2 EB05 8.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Drug screen positive | 30 | 10.0 7.0–14.4ROR 10.1 · χ² 235 / p 3e-53 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=29 | no trial data cached |
| Stupor | 12 | 9.8 5.6–17.3ROR 9.8 · χ² 86 / p 9e-21 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Acidosis | 28 | 9.6 6.7–14.0ROR 9.7 · χ² 208 / p 2e-47 | 8.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 · 92% 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 |
|---|---|---|---|---|---|---|
| Completed suicide (death by suicide) | 2,795 | 90.4 87.6–93.2ROR 138.6 · χ² 239,548 / p <1e-300 | 87.3 EB05 84.6 · IC025 +6.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 50.7 · 99% clinician | no trial data cached |
| Toxicity to various agents | 1,744 | 27.6 26.5–28.8ROR 35.1 · χ² 44,580 / p <1e-300 | 27.3 EB05 26.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · 98% clinician | no trial data cached |
| Drug abuse | 1,625 | 52.1 49.8–54.4ROR 65.2 · χ² 80,090 / p <1e-300 | 51.1 EB05 49.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · 99% clinician | no trial data cached |
| Death | 1,131 | 3.5 3.3–3.6ROR 3.9 · χ² 2,054 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.0 · 99% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 841 | 27.0 25.3–28.7ROR 30.0 · χ² 20,860 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.5 · 99% clinician | no trial data cached |
| Cardio-respiratory arrest | 807 | 51.4 48.1–54.9ROR 57.1 · χ² 39,134 / p <1e-300 | 50.4 EB05 47.5 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · 100% clinician | no trial data cached |
| Respiratory arrest | 762 | 74.1 69.2–79.3ROR 81.8 · χ² 53,405 / p <1e-300 | 71.9 EB05 67.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.1 · 99% clinician | no trial data cached |
| Poisoning | 616 | 135.0 124.9–145.9ROR 146.2 · χ² 77,795 / p <1e-300 | 127.9 EB05 119.6 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.6 · 99% clinician | no trial data cached |
| Overdose | 415 | 5.0 4.6–5.5ROR 5.3 · χ² 1,354 / p 1e-296 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Intentional drug misuse | 415 | 52.5 47.7–57.7ROR 55.3 · χ² 20,509 / p <1e-300 | 51.3 EB05 47.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 53.5 · 99% clinician | no trial data cached |
| Intentional overdose | 395 | 16.4 14.9–18.0ROR 17.2 · χ² 5,674 / p <1e-300 | 16.3 EB05 15.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 | no trial data cached |
| Drug toxicity | 362 | 70.8 63.9–78.4ROR 74.1 · χ² 24,183 / p <1e-300 | 68.7 EB05 62.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.9 · 93% clinician | no trial data cached |
| Exposure via ingestion | 240 | 273.2 239.6–311.5ROR 281.6 · χ² 58,643 / p <1e-300 | 242.5 EB05 217.8 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious n=232 · 100% clinician | no trial data cached |
| Suicide attempt | 193 | 8.4 7.3–9.6ROR 8.6 · χ² 1,246 / p 3e-273 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 · 92% clinician | no trial data cached |
| Multiple drug overdose | 159 | 85.7 73.3–100.3ROR 87.5 · χ² 12,813 / p <1e-300 | 82.2 EB05 72.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=159 · 98% 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 Ethanol?
In FDA FAERS, the most frequently co-reported reaction terms for Ethanol are toxicity to various agents, cardiac arrest, cardio-respiratory arrest, respiratory arrest, poisoning, drug toxicity. 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 Ethanol have an FDA boxed warning?
No. The FDA label retrieved for Ethanol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ethanol 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 059559eb-01ce-4a0f-bede-a3d3cbfb6055, effective 20251231; matched on
openfda.generic_name.exact:"ETHANOL") - 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, 532 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.