🇺🇸 Elexacaftor / Ivacaftor / Tezacaftor in United States

1,747 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.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 1,747

Most-reported reactions

1. Hospitalisation — 841 reports (48.14%)
2. Lower Respiratory Tract Infection — 183 reports (10.48%)
3. Death — 139 reports (7.96%)
4. Drug Interaction — 94 reports (5.38%)
5. Anxiety — 91 reports (5.21%)
6. Exposure During Pregnancy — 91 reports (5.21%)
7. Infective Pulmonary Exacerbation Of Cystic Fibrosis — 90 reports (5.15%)
8. Malaise — 78 reports (4.46%)
9. Off Label Use — 74 reports (4.24%)
10. Cystic Fibrosis — 66 reports (3.78%)

Source database →

Frequently asked questions

Is Elexacaftor / Ivacaftor / Tezacaftor approved in United States?

Elexacaftor / Ivacaftor / Tezacaftor does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Elexacaftor / Ivacaftor / Tezacaftor in United States?

Nottingham University Hospitals NHS Trust is the originator. The local marketing authorisation holder may differ — check the official source linked above.