🇺🇸 Brevibloc in United States

FDA authorised Brevibloc on 31 December 1986 · 102 US adverse-event reports

Marketing authorisations

FDA — authorised 31 December 1986

  • Application: NDA019386
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Status: approved

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. Bradycardia — 17 reports (16.67%)
  2. Cardiac Arrest — 15 reports (14.71%)
  3. Drug Ineffective — 15 reports (14.71%)
  4. Hypotension — 13 reports (12.75%)
  5. Ventricular Fibrillation — 9 reports (8.82%)
  6. Pulmonary Oedema — 8 reports (7.84%)
  7. Death — 7 reports (6.86%)
  8. Blood Pressure Decreased — 6 reports (5.88%)
  9. Cerebrovascular Accident — 6 reports (5.88%)
  10. Multi-Organ Failure — 6 reports (5.88%)

Source database →

Brevibloc in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Brevibloc approved in United States?

Yes. FDA authorised it on 31 December 1986; FDA has authorised it.

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

BAXTER HLTHCARE holds the US marketing authorisation.