Drug · FAERS side-effect profile with label screen
Alcohol side effects: what 38,590 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
38,590 reports · 96% serious · 24,471 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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 1Lab value / disease marker 10No 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.
- 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. 1,103 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 |
|---|---|---|---|---|---|---|
| Grip strength | 124 | 632.1 487.5–819.6ROR 634.1 · χ² 35,536 / p <1e-300 | 277.9 EB05 239.2 · IC025 +6.8 3/3 methods agree | No label text to screen | serious n=124 · ♀ 100% (drug 50%) · 100% clinician | no trial arm names this drug |
| Blood ethanol | 21 | 535.2 292.3–980.0ROR 535.5 · χ² 5,335 / p <1e-300 | 215.7 EB05 148.8 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=21 | no trial arm names this drug |
| Ex-drug abuser | 13 | 497.0 233.6–1,057.3ROR 497.2 · χ² 3,084 / p <1e-300 | 187.5 EB05 116.6 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=13 | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 278 | 390.5 334.7–455.7ROR 393.4 · χ² 62,226 / p <1e-300 | 222.8 EB05 201.6 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=278 · ♀ 100% (drug 50%) · 97% clinician | no trial arm names this drug |
| Lupus vulgaris | 481 | 371.0 330.4–416.5ROR 375.6 · χ² 104,611 / p <1e-300 | 217.6 EB05 201.8 · IC025 +7.3 3/3 methods agree | No label text to screen | serious n=481 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Postmortem blood drug level | 21 | 295.8 173.6–504.0ROR 296.0 · χ² 3,786 / p <1e-300 | 162.9 EB05 112.4 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=21 | no trial arm names this drug |
| Swollen joint count | 79 | 257.8 197.2–337.2ROR 258.4 · χ² 13,467 / p <1e-300 | 167.3 EB05 138.6 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=79 · ♀ 100% (drug 50%) · 100% clinician | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 174 | 255.9 213.6–306.4ROR 257.0 · χ² 29,714 / p <1e-300 | 170.2 EB05 150.0 · IC025 +6.6 3/3 methods agree | No label text to screen | serious n=174 · ♀ 100% (drug 50%) · 100% clinician | no trial arm names this drug |
| Alcohol interaction | 610 | 248.3 225.7–273.2ROR 252.3 · χ² 102,471 / p <1e-300 | 169.0 EB05 158.1 · IC025 +7.1 3/3 methods agree | No label text to screen | serious n=540 | no trial arm names this drug |
| Deep vein thrombosis postoperative | 557 | 216.2 196.0–238.4ROR 219.3 · χ² 84,837 / p <1e-300 | 153.5 EB05 143.1 · IC025 +6.9 3/3 methods agree | No label text to screen | serious n=557 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Alcohol test positive | 13 | 204.7 108.0–387.8ROR 204.7 · χ² 1,761 / p <1e-300 | 122.2 EB05 76.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Victim of crime | 322 | 203.5 179.0–231.3ROR 205.2 · χ² 46,864 / p <1e-300 | 146.4 EB05 133.5 · IC025 +6.7 3/3 methods agree | No label text to screen | serious n=322 · ♀ 92% (drug 50%) · 95% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 546 | 202.4 183.5–223.2ROR 205.3 · χ² 79,255 / p <1e-300 | 146.4 EB05 136.4 · IC025 +6.9 3/3 methods agree | No label text to screen | serious n=546 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Swollen joint count increased | 828 | 196.9 181.9–213.1ROR 201.2 · χ² 117,847 / p <1e-300 | 143.7 EB05 135.7 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=828 · ♀ 100% (drug 50%) · 98% clinician | no trial arm names this drug |
| Rheumatic fever | 1,130 | 190.1 177.7–203.3ROR 195.8 · χ² 156,731 / p <1e-300 | 140.2 EB05 133.5 · IC025 +7.0 3/3 methods agree | No label text to screen | serious n=1,130 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| C-reactive protein | 231 | 185.9 160.1–215.9ROR 187.0 · χ² 31,398 / p <1e-300 | 136.7 EB05 122.5 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=231 · ♀ 100% (drug 50%) · 98% clinician | no trial arm names this drug |
| Blood ethanol increased | 56 | 182.8 135.0–247.5ROR 183.0 · χ² 7,411 / p <1e-300 | 130.5 EB05 104.3 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=55 · 92% clinician | no trial arm names this drug |
| Postmortem blood drug level abnormal | 36 | 176.8 121.3–257.6ROR 176.9 · χ² 4,599 / p <1e-300 | 124.5 EB05 94.0 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=36 | no trial arm names this drug |
| Dislocation of vertebra | 533 | 171.5 155.7–189.0ROR 173.9 · χ² 68,316 / p <1e-300 | 129.6 EB05 120.6 · IC025 +6.7 3/3 methods agree | No label text to screen | serious n=533 · ♀ 100% (drug 50%) · 95% clinician | no trial arm names this drug |
| Facet joint syndrome | 753 | 170.9 157.5–185.3ROR 174.2 · χ² 96,270 / p <1e-300 | 129.3 EB05 121.8 · IC025 +6.8 3/3 methods agree | No label text to screen | serious n=753 · ♀ 100% (drug 50%) · 92% clinician | no trial arm names this drug |
| Chemical submission | 58 | 166.9 124.3–224.1ROR 167.2 · χ² 7,165 / p <1e-300 | 122.4 EB05 98.2 · IC025 +5.5 3/3 methods agree | No label text to screen | serious n=58 · ♀ 88% (drug 50%) · 100% clinician | no trial arm names this drug |
| X-ray abnormal | 414 | 164.4 147.3–183.4ROR 166.2 · χ² 51,313 / p <1e-300 | 125.3 EB05 115.5 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=414 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Hepatic enzyme | 32 | 161.6 108.8–239.9ROR 161.7 · χ² 3,800 / p <1e-300 | 115.9 EB05 86.0 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=32 · ♀ 100% (drug 50%) · 100% clinician | no trial arm names this drug |
| Behavioural addiction | 14 | 156.1 86.1–283.1ROR 156.2 · χ² 1,552 / p <1e-300 | 104.3 EB05 66.0 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=14 | no trial arm names this drug |
| Acquired porphyria | 15 | 146.0 82.5–258.3ROR 146.0 · χ² 1,585 / p <1e-300 | 100.6 EB05 64.7 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=15 | no trial arm names this drug |
| Alcohol poisoning | 560 | 145.6 132.7–159.7ROR 147.7 · χ² 63,107 / p <1e-300 | 114.2 EB05 106.5 · IC025 +6.6 3/3 methods agree | No label text to screen | serious n=551 | no trial arm names this drug |
| Blood alcohol increased | 163 | 141.6 119.2–168.3ROR 142.2 · χ² 17,888 / p <1e-300 | 110.8 EB05 97.2 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=156 | no trial arm names this drug |
| Retinitis | 338 | 138.1 122.6–155.6ROR 139.3 · χ² 36,463 / p <1e-300 | 109.3 EB05 99.9 · IC025 +6.4 3/3 methods agree | No label text to screen | serious n=338 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Alcohol abuse | 532 | 133.8 121.7–147.1ROR 135.7 · χ² 56,003 / p <1e-300 | 106.8 EB05 99.4 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=456 · ♀ 29% (drug 50%) | no trial arm names this drug |
| Duodenal ulcer perforation | 1,392 | 127.3 120.2–134.8ROR 132.0 · χ² 140,838 / p <1e-300 | 102.9 EB05 98.4 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 61.5 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Foetal alcohol syndrome | 18 | 117.5 70.5–195.7ROR 117.5 · χ² 1,610 / p <1e-300 | 87.8 EB05 58.8 · IC025 +4.0 3/3 methods agree | No label text to screen | serious n=18 | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 1,231 | 113.9 107.2–121.0ROR 117.6 · χ² 113,547 / p <1e-300 | 94.0 EB05 89.6 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious PRR 56.4 · ♀ 100% (drug 50%) · 95% clinician | no trial arm names this drug |
| Rheumatoid factor positive | 980 | 111.2 103.9–119.1ROR 114.1 · χ² 88,581 / p <1e-300 | 92.1 EB05 87.4 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=980 · ♀ 100% (drug 50%) · 97% clinician | no trial arm names this drug |
| Porphyria acute | 222 | 104.1 90.2–120.2ROR 104.7 · χ² 18,899 / p <1e-300 | 86.7 EB05 77.6 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=222 · ♀ 100% (drug 50%) · 95% clinician | no trial arm names this drug |
| Muscle injury | 1,292 | 101.6 95.8–107.7ROR 105.0 · χ² 108,088 / p <1e-300 | 85.4 EB05 81.6 · IC025 +6.3 3/3 methods agree | No label text to screen | serious PRR 55.4 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Helicobacter infection | 1,504 | 94.1 89.1–99.3ROR 97.8 · χ² 117,761 / p <1e-300 | 80.1 EB05 76.7 · IC025 +6.2 3/3 methods agree | No label text to screen | serious PRR 50.6 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Polysubstance dependence | 25 | 92.3 60.4–141.1ROR 92.3 · χ² 1,848 / p <1e-300 | 74.5 EB05 53.1 · IC025 +4.3 3/3 methods agree | No label text to screen | serious n=25 | no trial arm names this drug |
| Folliculitis | 1,475 | 90.5 85.8–95.6ROR 94.1 · χ² 111,691 / p <1e-300 | 77.5 EB05 74.2 · IC025 +6.2 3/3 methods agree | No label text to screen | serious PRR 54.4 · ♀ 100% (drug 50%) · 96% clinician | no trial arm names this drug |
| Sleep disorder due to general medical condition, insomnia type | 902 | 88.5 82.6–94.9ROR 90.6 · χ² 66,932 / p <1e-300 | 76.0 EB05 71.9 · IC025 +6.1 3/3 methods agree | No label text to screen | serious n=901 · ♀ 100% (drug 50%) · 98% clinician | no trial arm names this drug |
| Substance use disorder | 418 | 85.5 77.1–94.7ROR 86.4 · χ² 30,019 / p <1e-300 | 73.6 EB05 67.9 · IC025 +5.9 3/3 methods agree | No label text to screen | serious n=418 · ♀ 29% (drug 50%) · 93% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Alcohol (searched ALCOHOL).
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) | 8,249 | 59.0 57.8–60.3ROR 74.8 · χ² 425,544 / p <1e-300 | 53.3 EB05 52.3 · IC025 +5.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 31.8 · 98% clinician | no trial arm names this drug |
| Toxicity to various agents | 7,796 | 26.4 25.9–27.0ROR 32.9 · χ² 183,285 / p <1e-300 | 25.2 EB05 24.8 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 15.5 · 93% clinician | no trial arm names this drug |
| Drug abuse | 6,960 | 49.3 48.2–50.4ROR 59.9 · χ² 302,629 / p <1e-300 | 45.2 EB05 44.3 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 27.2 · ♀ 29% (drug 50%) · 93% clinician | no trial arm names this drug |
| Death | 2,923 | 1.8 1.8–1.9ROR 1.9 · χ² 1,180 / p 9e-259 | 1.8 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.1 · 95% clinician | no trial arm names this drug |
| Overdose | 2,443 | 6.2 6.0–6.4ROR 6.5 · χ² 10,608 / p <1e-300 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial arm names this drug |
| Cardio-respiratory arrest | 2,153 | 29.3 28.1–30.5ROR 30.9 · χ² 55,806 / p <1e-300 | 27.8 EB05 26.8 · IC025 +4.7 3/3 methods agree | No label text to screen | serious PRR 16.6 · 100% clinician | no trial arm names this drug |
| Intentional overdose | 1,964 | 17.2 16.5–18.0ROR 18.1 · χ² 29,195 / p <1e-300 | 16.7 EB05 16.1 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial arm names this drug |
| Vomiting | 1,866 | 2.2 2.1–2.3ROR 2.2 · χ² 1,194 / p 5e-262 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 1.9 · ♀ 79% (drug 50%) | no trial arm names this drug |
| Confusional state (confusion) | 1,841 | 6.2 6.0–6.5ROR 6.5 · χ² 8,063 / p <1e-300 | 6.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen | serious PRR 4.6 · ♀ 86% (drug 50%) · 91% clinician | no trial arm names this drug |
| Fatigue (tiredness) | 1,746 | 1.2 1.2–1.3ROR 1.2 · χ² 73 / p 8e-18 | 1.2 EB05 1.2 · IC025 +0.2 | No label text to screen | serious PRR 1.3 · ♀ 91% (drug 50%) | no trial arm names this drug |
| Pain | 1,708 | 1.5 1.4–1.6ROR 1.5 · χ² 302 / p 7e-68 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen | serious PRR 1.4 · ♀ 91% (drug 50%) | no trial arm names this drug |
| Nausea | 1,647 | 1.1 1.1–1.2ROR 1.1 · χ² 27 / p 9e-8 | 1.1 EB05 1.1 · IC025 +0.1 | No label text to screen | serious PRR 1.2 · ♀ 85% (drug 50%) | no trial arm names this drug |
| Cardiac arrest (heart stopping) | 1,596 | 10.7 10.2–11.2ROR 11.1 · χ² 13,735 / p <1e-300 | 10.5 EB05 10.0 · IC025 +3.3 3/3 methods agree | No label text to screen | serious PRR 6.2 · 96% clinician | no trial arm names this drug |
| Rash | 1,580 | 2.0 1.9–2.1ROR 2.0 · χ² 783 / p 1e-172 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 2.6 · ♀ 97% (drug 50%) · 93% clinician | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,560 | 1.5 1.4–1.6ROR 1.5 · χ² 266 / p 4e-60 | 1.5 EB05 1.4 · IC025 +0.5 | No label text to screen | serious PRR 1.2 · ♀ 90% (drug 50%) | 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 Alcohol?
In FDA FAERS, the most frequently co-reported reaction terms for Alcohol are toxicity to various agents, cardio-respiratory arrest, vomiting, confusional state, fatigue, pain. 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 Alcohol have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,143 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
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.