🇺🇸 Acetaminophen-Hydrocodone in United States

53,909 US adverse-event reports

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: 21 April 2025 – 21 April 2026
• Total reports: 53,909

Most-reported reactions

1. Dependence — 27,039 reports (50.16%)
2. Overdose — 8,619 reports (15.99%)
3. Ill-Defined Disorder — 5,906 reports (10.96%)
4. Death — 2,761 reports (5.12%)
5. Foetal Exposure During Pregnancy — 1,976 reports (3.67%)
6. Drug Withdrawal Syndrome Neonatal — 1,974 reports (3.66%)
7. Completed Suicide — 1,610 reports (2.99%)
8. Withdrawal Syndrome — 1,482 reports (2.75%)
9. Pain — 1,341 reports (2.49%)
10. Fatigue — 1,201 reports (2.23%)

Source database →

Frequently asked questions

Is Acetaminophen-Hydrocodone approved in United States?

Acetaminophen-Hydrocodone does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Acetaminophen-Hydrocodone in United States?

Le Bonheur Children's Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.