🇺🇸 Hiberix in United States

12 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. Drug Ineffective — 2 reports (16.67%)
  2. No Adverse Event — 2 reports (16.67%)
  3. Anorectal Discomfort — 1 report (8.33%)
  4. Asthma — 1 report (8.33%)
  5. Colitis Ulcerative — 1 report (8.33%)
  6. Constipation — 1 report (8.33%)
  7. Crohn^S Disease — 1 report (8.33%)
  8. Decreased Appetite — 1 report (8.33%)
  9. Dehydration — 1 report (8.33%)
  10. Diarrhoea — 1 report (8.33%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Hiberix approved in United States?

Yes. FDA has authorised it.

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

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