🇺🇸 Bupivacaine epidural in United States

21 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. Blood Pressure Decreased — 5 reports (23.81%)
  2. Anaesthetic Complication — 3 reports (14.29%)
  3. Exposure During Pregnancy — 3 reports (14.29%)
  4. Product Quality Issue — 3 reports (14.29%)
  5. Product Lot Number Issue — 2 reports (9.52%)
  6. Agitation — 1 report (4.76%)
  7. Asterixis — 1 report (4.76%)
  8. Ballismus — 1 report (4.76%)
  9. Confusional State — 1 report (4.76%)
  10. Extradural Haematoma — 1 report (4.76%)

Source database →

Bupivacaine epidural 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 Bupivacaine epidural approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Bupivacaine epidural in United States?

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