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What the label lists and what reports show

Alcohol side effects

Alcohol's FDA label lists its adverse reactions in its own words. FAERS holds 38,590 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (7,797 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the alcohol FDA label on DailyMed (effective August 27, 2026, Breckenridge Pharmaceutical Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Heart block [see Warnings and precautions (5.1) ] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as dehydrated alcohol injection, were identified in the literature: Ventricular tachycardia and ventricular fibrillation. Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Breckenridge Pharmaceutical Inc, effective August 27, 2026 (SPL set be10b253-d72a-4f57-aa27-94c70ae8aed3), via openFDA; the full label on DailyMed

What do FAERS reports show?

38,590 reports list alcohol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24,471 are coded as a death and 12,152 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Completed Suicide (an outcome recorded in the report)8,249
  • Toxicity To Various Agents7,797
  • Drug Abuse6,960
  • Death (an outcome recorded in the report)2,923
  • Overdose (a use or a product term, not a reaction)2,443
  • Cardio-Respiratory Arrest2,152
  • Intentional Overdose (a use or a product term, not a reaction)1,963
  • Vomiting1,866
  • Confusional State1,841
  • Fatigue1,745
  • Pain1,709
  • Nausea1,647
  • Cardiac Arrest1,596
  • Rash1,580
  • Dyspnoea1,560
  • Suicide Attempt1,554
  • Hepatic Enzyme Increased1,546
  • Off Label Use (a use or a product term, not a reaction)1,540
  • Glossodynia1,531
  • Pemphigus1,529
  • Hypersensitivity1,525
  • Joint Swelling1,525
  • Hand Deformity1,509
  • Injury1,507
  • Irritable Bowel Syndrome1,505

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Alcohol: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions