🇺🇸 Additive solution in United States

17 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. Off Label Use — 6 reports (35.29%)
  2. Necrosis — 4 reports (23.53%)
  3. Soft Tissue Necrosis — 2 reports (11.76%)
  4. Blood Glucose Increased — 1 report (5.88%)
  5. Blood Pressure Increased — 1 report (5.88%)
  6. Loss Of Consciousness — 1 report (5.88%)
  7. Myocardial Infarction — 1 report (5.88%)
  8. Seizure — 1 report (5.88%)

Source database →

Additive solution 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 Additive solution approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Additive solution in United States?

Etablissement Français du Sang is the originator. The local marketing authorisation holder may differ — check the official source linked above.