🇺🇸 Eklira in United States

169 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. Dyspnoea — 27 reports (15.98%)
  2. Atrial Fibrillation — 20 reports (11.83%)
  3. Device Malfunction — 20 reports (11.83%)
  4. Nausea — 18 reports (10.65%)
  5. Malaise — 16 reports (9.47%)
  6. Dizziness — 15 reports (8.88%)
  7. Bradycardia — 14 reports (8.28%)
  8. Pneumonia — 14 reports (8.28%)
  9. Electrocardiogram Abnormal — 13 reports (7.69%)
  10. Visual Impairment — 12 reports (7.1%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Eklira approved in United States?

Yes. FDA has authorised it.

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

Fundacio Privada Mon Clinic Barcelona is the originator. The local marketing authorisation holder may differ — check the official source linked above.