🇺🇸 Tezacaftor/Ivacaftor in United States

28 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: 23 April 2025 – 23 April 2026
• Total reports: 28

Most-reported reactions

1. Infective Pulmonary Exacerbation Of Cystic Fibrosis — 5 reports (17.86%)
2. Off Label Use — 5 reports (17.86%)
3. No Adverse Event — 4 reports (14.29%)
4. Abdominal Pain — 2 reports (7.14%)
5. Atrioventricular Block First Degree — 2 reports (7.14%)
6. Diarrhoea — 2 reports (7.14%)
7. Drug Ineffective — 2 reports (7.14%)
8. Haemoptysis — 2 reports (7.14%)
9. Pulmonary Congestion — 2 reports (7.14%)
10. Rash Macular — 2 reports (7.14%)

Source database →

Frequently asked questions

Is Tezacaftor/Ivacaftor approved in United States?

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

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

Vertex Pharmaceuticals Incorporated is the originator. The local marketing authorisation holder may differ — check the official source linked above.