🇺🇸 Baraclude in United States

1,330 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. Death — 265 reports (19.92%)
  2. Fatigue — 149 reports (11.2%)
  3. Nausea — 145 reports (10.9%)
  4. Diarrhoea — 139 reports (10.45%)
  5. Off Label Use — 120 reports (9.02%)
  6. Pyrexia — 117 reports (8.8%)
  7. Malaise — 102 reports (7.67%)
  8. Drug Ineffective — 99 reports (7.44%)
  9. Hepatic Failure — 97 reports (7.29%)
  10. Hepatitis B — 97 reports (7.29%)

Source database →

Baraclude in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is Baraclude approved in United States?

Yes. FDA has authorised it.

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

Bristol-Myers Squibb is the originator. The local marketing authorisation holder may differ — check the official source linked above.