🇺🇸 Surfactant in United States

58 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. Gastrointestinal Perforation — 7 reports (12.07%)
  2. Sepsis Neonatal — 7 reports (12.07%)
  3. Intraventricular Haemorrhage Neonatal — 6 reports (10.34%)
  4. Neonatal Disorder — 6 reports (10.34%)
  5. Neonatal Respiratory Distress Syndrome — 6 reports (10.34%)
  6. Off Label Use — 6 reports (10.34%)
  7. Hypertrophic Cardiomyopathy — 5 reports (8.62%)
  8. Multiple Organ Dysfunction Syndrome — 5 reports (8.62%)
  9. Neonatal Hypoxia — 5 reports (8.62%)
  10. Neonatal Infection — 5 reports (8.62%)

Source database →

Surfactant 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 Surfactant approved in United States?

Yes. FDA has authorised it.

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

Sood, Beena G., MD, MS is the originator. The local marketing authorisation holder may differ — check the official source linked above.