🇺🇸 Kaftrio in United States

211 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. Hospitalisation — 107 reports (50.71%)
  2. Lower Respiratory Tract Infection — 21 reports (9.95%)
  3. Death — 15 reports (7.11%)
  4. Cystic Fibrosis — 12 reports (5.69%)
  5. Haemoptysis — 11 reports (5.21%)
  6. Abdominal Pain — 10 reports (4.74%)
  7. Infection — 10 reports (4.74%)
  8. Feeling Abnormal — 9 reports (4.27%)
  9. Infective Pulmonary Exacerbation Of Cystic Fibrosis — 8 reports (3.79%)
  10. Malaise — 8 reports (3.79%)

Source database →

Kaftrio in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Kaftrio approved in United States?

Yes. FDA has authorised it.

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

Royal College of Surgeons, Ireland is the originator. The local marketing authorisation holder may differ — check the official source linked above.