🇺🇸 Plenadren 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. Dizziness — 2 reports (16.67%)
  2. Vestibular Neuronitis — 2 reports (16.67%)
  3. Abdominal Pain Lower — 1 report (8.33%)
  4. Cholelithiasis — 1 report (8.33%)
  5. Dehydration — 1 report (8.33%)
  6. Dermatitis Atopic — 1 report (8.33%)
  7. Diarrhoea — 1 report (8.33%)
  8. Fatigue — 1 report (8.33%)
  9. General Physical Health Deterioration — 1 report (8.33%)
  10. Hepatic Failure — 1 report (8.33%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Plenadren approved in United States?

Yes. FDA has authorised it.

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

Ulla Feldt-Rasmussen is the originator. The local marketing authorisation holder may differ — check the official source linked above.