🇺🇸 Recombivax in United States

56 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 — 15 reports (26.79%)
  2. Product Storage Error — 8 reports (14.29%)
  3. Diarrhoea — 5 reports (8.93%)
  4. Dyspnoea — 5 reports (8.93%)
  5. Incorrect Product Storage — 5 reports (8.93%)
  6. Acute Kidney Injury — 4 reports (7.14%)
  7. Nausea — 4 reports (7.14%)
  8. Vomiting — 4 reports (7.14%)
  9. Abdominal Pain — 3 reports (5.36%)
  10. Condition Aggravated — 3 reports (5.36%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Recombivax approved in United States?

Yes. FDA has authorised it.

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

University of North Carolina, Chapel Hill is the originator. The local marketing authorisation holder may differ — check the official source linked above.