🇺🇸 Pediarix in United States

23 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. No Adverse Event — 5 reports (21.74%)
  2. Death — 3 reports (13.04%)
  3. Extra Dose Administered — 3 reports (13.04%)
  4. Dyspnoea — 2 reports (8.7%)
  5. Expired Product Administered — 2 reports (8.7%)
  6. Incorrect Dose Administered — 2 reports (8.7%)
  7. Pneumonia — 2 reports (8.7%)
  8. Pyrexia — 2 reports (8.7%)
  9. Abnormal Faeces — 1 report (4.35%)
  10. Acute Respiratory Failure — 1 report (4.35%)

Source database →

Pediarix in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Pediarix approved in United States?

Yes. FDA has authorised it.

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

Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.