🇺🇸 ALCOHOL in United States

31,296 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 20 April 2025 – 20 April 2026
• Total reports: 31,296

Most-reported reactions

1. Toxicity To Various Agents — 5,807 reports (18.56%)
2. Completed Suicide — 5,331 reports (17.03%)
3. Drug Abuse — 5,219 reports (16.68%)
4. Fatigue — 2,240 reports (7.16%)
5. Confusional State — 2,179 reports (6.96%)
6. Overdose — 2,176 reports (6.95%)
7. Vomiting — 2,172 reports (6.94%)
8. Pain — 2,161 reports (6.91%)
9. Rash — 2,075 reports (6.63%)
10. Dyspnoea — 1,936 reports (6.19%)

Source database →

Frequently asked questions

Is ALCOHOL approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for ALCOHOL in United States?

Marketing authorisation holder not available in our data.