🇺🇸 Heplisav -B in United States

43 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 Hypersensitivity — 7 reports (16.28%)
  2. Product Dose Omission Issue — 6 reports (13.95%)
  3. Nausea — 5 reports (11.63%)
  4. Diarrhoea — 4 reports (9.3%)
  5. Drug Ineffective — 4 reports (9.3%)
  6. Fatigue — 4 reports (9.3%)
  7. Vomiting — 4 reports (9.3%)
  8. Inappropriate Schedule Of Product Administration — 3 reports (6.98%)
  9. Pain — 3 reports (6.98%)
  10. Pruritus — 3 reports (6.98%)

Source database →

Heplisav -B in other countries

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

Frequently asked questions

Is Heplisav -B approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Heplisav -B in United States?

National Heart, Lung, and Blood Institute (NHLBI) is the originator. The local marketing authorisation holder may differ — check the official source linked above.