🇺🇸 Baby aspirin in United States

11,836 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.

Most-reported reactions

  1. Drug Ineffective — 1,644 reports (13.89%)
  2. Fatigue — 1,456 reports (12.3%)
  3. Nausea — 1,229 reports (10.38%)
  4. Dyspnoea — 1,173 reports (9.91%)
  5. Dizziness — 1,166 reports (9.85%)
  6. Diarrhoea — 1,154 reports (9.75%)
  7. Headache — 1,085 reports (9.17%)
  8. Pain — 1,007 reports (8.51%)
  9. Off Label Use — 1,002 reports (8.47%)
  10. Asthenia — 920 reports (7.77%)

Source database →

Baby aspirin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Baby aspirin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Baby aspirin in United States?

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