🇺🇸 Xoterna in United States

55 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. Chronic Obstructive Pulmonary Disease — 10 reports (18.18%)
  2. Dyspnoea — 9 reports (16.36%)
  3. Lung Neoplasm Malignant — 6 reports (10.91%)
  4. Arrhythmia — 5 reports (9.09%)
  5. Cough — 5 reports (9.09%)
  6. Chest Pain — 4 reports (7.27%)
  7. Drug Ineffective — 4 reports (7.27%)
  8. Fatigue — 4 reports (7.27%)
  9. Forced Expiratory Volume Decreased — 4 reports (7.27%)
  10. Malaise — 4 reports (7.27%)

Source database →

Xoterna in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Xoterna approved in United States?

Yes. FDA has authorised it.

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

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