🇺🇸 Beyfortus in United States

FDA authorised Beyfortus on 17 July 2023 · 1,001 US adverse-event reports

Marketing authorisations

FDA — authorised 17 July 2023

  • Application: BLA761328
  • Marketing authorisation holder: ASTRAZENECA AB
  • Status: supplemented

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. Drug Ineffective — 209 reports (20.88%)
  2. Incorrect Dose Administered — 185 reports (18.48%)
  3. Respiratory Syncytial Virus Bronchiolitis — 163 reports (16.28%)
  4. Bronchiolitis — 101 reports (10.09%)
  5. Respiratory Syncytial Virus Infection — 95 reports (9.49%)
  6. Pyrexia — 63 reports (6.29%)
  7. Cough — 56 reports (5.59%)
  8. Extra Dose Administered — 54 reports (5.39%)
  9. Respiratory Syncytial Virus Test Positive — 38 reports (3.8%)
  10. Product Storage Error — 37 reports (3.7%)

Source database →

Beyfortus in other countries

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

Other Respiratory approved in United States

Frequently asked questions

Is Beyfortus approved in United States?

Yes. FDA authorised it on 17 July 2023; FDA has authorised it.

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

ASTRAZENECA AB holds the US marketing authorisation.