🇺🇸 Ruconest in United States

4,363 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. Hereditary Angioedema — 949 reports (21.75%)
  2. Intentional Product Use Issue — 715 reports (16.39%)
  3. Drug Ineffective For Unapproved Indication — 510 reports (11.69%)
  4. Drug Ineffective — 410 reports (9.4%)
  5. Condition Aggravated — 384 reports (8.8%)
  6. Product Use In Unapproved Indication — 380 reports (8.71%)
  7. Pharyngeal Swelling — 359 reports (8.23%)
  8. Weight Decreased — 228 reports (5.23%)
  9. Product Dose Omission Issue — 214 reports (4.9%)
  10. Weight Increased — 214 reports (4.9%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ruconest approved in United States?

Yes. FDA has authorised it.

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

Bernstein Clinical Research Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.