🇺🇸 haloperidole in United States

10 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: 27 March 2025 – 27 March 2026
• Total reports: 10

Most-reported reactions

1. Alcohol Abuse — 1 report (10%)
2. Atrioventricular Block Second Degree — 1 report (10%)
3. Catheterisation Cardiac — 1 report (10%)
4. Cerebral Ischaemia — 1 report (10%)
5. Disease Progression — 1 report (10%)
6. Disease Recurrence — 1 report (10%)
7. Drug Abuse — 1 report (10%)
8. Drug Ineffective — 1 report (10%)
9. Dyskinesia — 1 report (10%)
10. Dystonia — 1 report (10%)

Source database →

Frequently asked questions

Is haloperidole approved in United States?

Yes. FDA has authorised it.

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

Janssen Scientific Affairs, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.