🇺🇸 Onbrez in United States

2,020 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 — 514 reports (25.45%)
  2. Death — 276 reports (13.66%)
  3. Cough — 226 reports (11.19%)
  4. Pneumonia — 218 reports (10.79%)
  5. Chronic Obstructive Pulmonary Disease — 192 reports (9.5%)
  6. Malaise — 174 reports (8.61%)
  7. Fatigue — 121 reports (5.99%)
  8. Lung Disorder — 107 reports (5.3%)
  9. Asthma — 97 reports (4.8%)
  10. Fall — 95 reports (4.7%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Onbrez approved in United States?

Yes. FDA has authorised it.

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

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