🇺🇸 Aspirin 100 mg in United States

169 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.

• Window: 20 April 2025 – 20 April 2026
• Total reports: 169

Most-reported reactions

1. General Physical Health Deterioration — 21 reports (12.43%)
2. Haematochezia — 21 reports (12.43%)
3. Toxic Epidermal Necrolysis — 21 reports (12.43%)
4. Blister — 19 reports (11.24%)
5. Stevens-Johnson Syndrome — 17 reports (10.06%)
6. Anaemia — 16 reports (9.47%)
7. Erythema — 14 reports (8.28%)
8. Nausea — 14 reports (8.28%)
9. Conjunctivitis — 13 reports (7.69%)
10. Mucosal Erosion — 13 reports (7.69%)

Source database →

Frequently asked questions

Is Aspirin 100 mg approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Aspirin 100 mg in United States?

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