🇺🇸 Mutaflor in United States

97 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. Diarrhoea — 20 reports (20.62%)
  2. Faecaloma — 13 reports (13.4%)
  3. Abdominal Pain Lower — 12 reports (12.37%)
  4. Abdominal Pain — 11 reports (11.34%)
  5. Colitis Ulcerative — 9 reports (9.28%)
  6. Pneumonia — 8 reports (8.25%)
  7. Asthenia — 6 reports (6.19%)
  8. Fatigue — 6 reports (6.19%)
  9. General Physical Health Deterioration — 6 reports (6.19%)
  10. Tachycardia — 6 reports (6.19%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Mutaflor approved in United States?

Yes. FDA has authorised it.

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

Charite University, Berlin, Germany is the originator. The local marketing authorisation holder may differ — check the official source linked above.