🇺🇸 Activated protein C in United States

11 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. Septic Shock — 2 reports (18.18%)
  2. Ascites — 1 report (9.09%)
  3. Atelectasis — 1 report (9.09%)
  4. Blood Creatine Increased — 1 report (9.09%)
  5. Blood Lactic Acid Increased — 1 report (9.09%)
  6. Blood Ph Increased — 1 report (9.09%)
  7. Blood Sodium Decreased — 1 report (9.09%)
  8. Blood Urea Increased — 1 report (9.09%)
  9. Death — 1 report (9.09%)
  10. Febrile Neutropenia — 1 report (9.09%)

Source database →

Activated protein C 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 Activated protein C approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Activated protein C in United States?

Helsinki University Central Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.