🇺🇸 Prothrombin complex in United States

301 US adverse-event reports

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. Off Label Use — 58 reports (19.27%)
  2. Drug Ineffective — 39 reports (12.96%)
  3. Product Use In Unapproved Indication — 36 reports (11.96%)
  4. No Adverse Event — 34 reports (11.3%)
  5. Deep Vein Thrombosis — 26 reports (8.64%)
  6. Ischaemic Stroke — 25 reports (8.31%)
  7. Haemorrhage — 24 reports (7.97%)
  8. Embolism — 23 reports (7.64%)
  9. Pulmonary Embolism — 22 reports (7.31%)
  10. Acute Kidney Injury — 14 reports (4.65%)

Source database →

Other Hematology approved in United States

Frequently asked questions

Is Prothrombin complex approved in United States?

Prothrombin complex does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Prothrombin complex in United States?

IRCCS Policlinico S. Donato is the originator. The local marketing authorisation holder may differ — check the official source linked above.