🇺🇸 paracetamol + caffeine in United States

167 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: 23 April 2025 – 23 April 2026
• Total reports: 167

Most-reported reactions

1. Pain — 25 reports (14.97%)
2. Hypotension — 18 reports (10.78%)
3. Vomiting — 18 reports (10.78%)
4. Dizziness — 17 reports (10.18%)
5. Drug Ineffective — 17 reports (10.18%)
6. Headache — 15 reports (8.98%)
7. Joint Swelling — 15 reports (8.98%)
8. Intentional Overdose — 14 reports (8.38%)
9. Mobility Decreased — 14 reports (8.38%)
10. Toxicity To Various Agents — 14 reports (8.38%)

Source database →

Frequently asked questions

Is paracetamol + caffeine approved in United States?

paracetamol + caffeine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for paracetamol + caffeine in United States?

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