🇺🇸 Bacillus clausii in United States

20 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: 20

Most-reported reactions

1. Vomiting — 4 reports (20%)
2. Diarrhoea — 3 reports (15%)
3. Nausea — 3 reports (15%)
4. Dehydration — 2 reports (10%)
5. Off Label Use — 2 reports (10%)
6. Pyrexia — 2 reports (10%)
7. Abdominal Pain Upper — 1 report (5%)
8. Anal Fissure — 1 report (5%)
9. Anaphylactic Shock — 1 report (5%)
10. Aplasia — 1 report (5%)

Source database →

Frequently asked questions

Is Bacillus clausii approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Bacillus clausii in United States?

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