🇺🇸 Tredaptive in United States

119 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. Myalgia — 24 reports (20.17%)
  2. Rash — 19 reports (15.97%)
  3. Abdominal Discomfort — 14 reports (11.76%)
  4. Angioedema — 10 reports (8.4%)
  5. Cognitive Disorder — 10 reports (8.4%)
  6. Constipation — 10 reports (8.4%)
  7. Pruritus — 9 reports (7.56%)
  8. Diarrhoea — 8 reports (6.72%)
  9. Gastrointestinal Disorder — 8 reports (6.72%)
  10. Faecal Incontinence — 7 reports (5.88%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Tredaptive approved in United States?

Yes. FDA has authorised it.

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

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