🇺🇸 Bacillus coagulans in United States

121 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. Nausea — 19 reports (15.7%)
  2. Fatigue — 16 reports (13.22%)
  3. Pain — 14 reports (11.57%)
  4. Blood Pressure Increased — 11 reports (9.09%)
  5. Diarrhoea — 11 reports (9.09%)
  6. Headache — 11 reports (9.09%)
  7. Condition Aggravated — 10 reports (8.26%)
  8. Drug Ineffective — 10 reports (8.26%)
  9. Pneumonia — 10 reports (8.26%)
  10. Dizziness — 9 reports (7.44%)

Source database →

Bacillus coagulans 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 Bacillus coagulans approved in United States?

Yes. FDA has authorised it.

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

Xijing Hospital of Digestive Diseases is the originator. The local marketing authorisation holder may differ — check the official source linked above.