🇺🇸 fibrate in United States

44 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. Drug Ineffective — 7 reports (15.91%)
  2. Myalgia — 6 reports (13.64%)
  3. Dyspnoea — 5 reports (11.36%)
  4. Headache — 5 reports (11.36%)
  5. Necrotising Fasciitis — 5 reports (11.36%)
  6. Insomnia — 4 reports (9.09%)
  7. Blood Triglycerides Increased — 3 reports (6.82%)
  8. Myocardial Infarction — 3 reports (6.82%)
  9. Nausea — 3 reports (6.82%)
  10. Pneumonia — 3 reports (6.82%)

Source database →

Other Other approved in United States

Frequently asked questions

Is fibrate approved in United States?

Yes. FDA has authorised it.

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

University of Campania Luigi Vanvitelli is the originator. The local marketing authorisation holder may differ — check the official source linked above.