🇺🇸 C1-inhibitor in United States

125 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 — 40 reports (32%)
  2. Prescribed Overdose — 19 reports (15.2%)
  3. Drug Ineffective — 14 reports (11.2%)
  4. Product Use In Unapproved Indication — 11 reports (8.8%)
  5. Off Label Use — 9 reports (7.2%)
  6. Inappropriate Schedule Of Product Administration — 8 reports (6.4%)
  7. Intentional Product Use Issue — 7 reports (5.6%)
  8. Malaise — 7 reports (5.6%)
  9. Pneumonia — 6 reports (4.8%)
  10. Anxiety — 4 reports (3.2%)

Source database →

C1-inhibitor 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 C1-inhibitor approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for C1-inhibitor in United States?

TSI, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.