🇺🇸 Acetaminophen/Codeine in United States

10,055 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: 10,055

Most-reported reactions

1. Pain — 1,469 reports (14.61%)
2. Drug Ineffective — 1,151 reports (11.45%)
3. Fatigue — 1,111 reports (11.05%)
4. Off Label Use — 1,066 reports (10.6%)
5. Arthralgia — 944 reports (9.39%)
6. Rash — 919 reports (9.14%)
7. Headache — 882 reports (8.77%)
8. Nausea — 863 reports (8.58%)
9. Rheumatoid Arthritis — 845 reports (8.4%)
10. Diarrhoea — 805 reports (8.01%)

Source database →

Frequently asked questions

Is Acetaminophen/Codeine approved in United States?

Acetaminophen/Codeine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Acetaminophen/Codeine in United States?

University of Pennsylvania is the originator. The local marketing authorisation holder may differ — check the official source linked above.