🇺🇸 Acetaminophen (paracetamol) in United States

1,335 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: 1,335

Most-reported reactions

1. Completed Suicide — 477 reports (35.73%)
2. Toxicity To Various Agents — 182 reports (13.63%)
3. Intentional Drug Misuse — 132 reports (9.89%)
4. Drug Abuse — 96 reports (7.19%)
5. Cardio-Respiratory Arrest — 88 reports (6.59%)
6. Death — 88 reports (6.59%)
7. Nausea — 74 reports (5.54%)
8. Vomiting — 72 reports (5.39%)
9. Exposure Via Ingestion — 63 reports (4.72%)
10. Headache — 63 reports (4.72%)

Source database →

Frequently asked questions

Is Acetaminophen (paracetamol) approved in United States?

Acetaminophen (paracetamol) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Acetaminophen (paracetamol) in United States?

Hellenic Society of Hematology is the originator. The local marketing authorisation holder may differ — check the official source linked above.