🇺🇸 Fecal Microbiota Transplant in United States

12 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 — 2 reports (16.67%)
  2. Fatigue — 2 reports (16.67%)
  3. Acidosis — 1 report (8.33%)
  4. Atrial Fibrillation — 1 report (8.33%)
  5. Blood Culture Positive — 1 report (8.33%)
  6. Decreased Appetite — 1 report (8.33%)
  7. Enterobacter Infection — 1 report (8.33%)
  8. Hypoxia — 1 report (8.33%)
  9. Pneumonia — 1 report (8.33%)
  10. Refusal Of Treatment By Patient — 1 report (8.33%)

Source database →

Fecal Microbiota Transplant 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 Fecal Microbiota Transplant approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fecal Microbiota Transplant in United States?

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