🇺🇸 Silimarine in United States

10 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: 27 March 2025 – 27 March 2026
• Total reports: 10

Most-reported reactions

1. Asthenia — 1 report (10%)
2. Cardiac Failure — 1 report (10%)
3. Cardiopulmonary Failure — 1 report (10%)
4. Coma — 1 report (10%)
5. Covid-19 — 1 report (10%)
6. Dyspnoea — 1 report (10%)
7. Eye Haemorrhage — 1 report (10%)
8. Hepatic Failure — 1 report (10%)
9. Infection — 1 report (10%)
10. Metabolic Acidosis — 1 report (10%)

Source database →

Frequently asked questions

Is Silimarine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Silimarine in United States?

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia is the originator. The local marketing authorisation holder may differ — check the official source linked above.