🇺🇸 Fleet in United States

1,061 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 — 137 reports (12.91%)
  2. Renal Failure Chronic — 114 reports (10.74%)
  3. Renal Failure Acute — 113 reports (10.65%)
  4. Renal Failure — 112 reports (10.56%)
  5. Vomiting — 109 reports (10.27%)
  6. Fatigue — 108 reports (10.18%)
  7. Pain — 103 reports (9.71%)
  8. Diarrhoea — 101 reports (9.52%)
  9. Constipation — 84 reports (7.92%)
  10. Death — 80 reports (7.54%)

Source database →

Fleet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Fleet approved in United States?

Yes. FDA has authorised it.

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

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