Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

IVACAFTOR\TEZACAFTOR: 5,420 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
5,420
Total FAERS Reports
95 (1.8%)
Deaths Reported
3,026
Hospitalizations
5,420
As Primary/Secondary Suspect
19
Life-Threatening
8
Disabilities

First Report: 2017 · Latest Report: 20250901

What Are the Most Common IVACAFTOR\TEZACAFTOR Side Effects?

#1 Most Reported
Infective pulmonary exacerbation of cystic fibrosis
1,211 reports (22.3%)
#2 Most Reported
Hospitalisation
593 reports (10.9%)
#3 Most Reported
Infection
333 reports (6.1%)

All IVACAFTOR\TEZACAFTOR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infective pulmonary exacerbation of cystic fibrosis 1,211 22.3% 4 1,002
Hospitalisation 593 10.9% 11 588
Infection 333 6.1% 1 186
Pneumonia 247 4.6% 2 207
Headache 214 4.0% 1 20
Cystic fibrosis 194 3.6% 4 176
Cough 178 3.3% 0 60
Cystic fibrosis respiratory infection suppression 153 2.8% 0 151
Pulmonary function test decreased 153 2.8% 2 108
Haemoptysis 139 2.6% 0 91
Nausea 138 2.6% 0 26
Dyspnoea 137 2.5% 2 63
Malaise 128 2.4% 0 57
Nasopharyngitis 100 1.9% 1 22
Fatigue 96 1.8% 0 24
Influenza 85 1.6% 0 45
Dizziness 83 1.5% 0 17
Abdominal pain upper 82 1.5% 1 18
Weight decreased 81 1.5% 2 48
Sinusitis 73 1.4% 0 15

Who Reports IVACAFTOR\TEZACAFTOR Side Effects? Age & Gender Data

Gender: 57.3% female, 42.7% male. Average age: 26.2 years. Most reports from: US. View detailed demographics →

Is IVACAFTOR\TEZACAFTOR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 10 0 4
2018 1,343 16 643
2019 2,434 39 1,610
2020 486 17 303
2021 63 2 49
2022 22 1 13
2023 24 0 16
2024 18 0 13
2025 10 0 8

View full timeline →

What Is IVACAFTOR\TEZACAFTOR Used For?

IndicationReports
Cystic fibrosis 5,227
Product used for unknown indication 14
Bacterial disease carrier 9

IVACAFTOR\TEZACAFTOR vs Alternatives: Which Is Safer?

IVACAFTOR\TEZACAFTOR vs IVERMECTIN IVACAFTOR\TEZACAFTOR vs IVOSIDENIB IVACAFTOR\TEZACAFTOR vs IXABEPILONE IVACAFTOR\TEZACAFTOR vs IXAZOMIB IVACAFTOR\TEZACAFTOR vs IXEKIZUMAB IVACAFTOR\TEZACAFTOR vs JAKAFI IVACAFTOR\TEZACAFTOR vs JANUMET IVACAFTOR\TEZACAFTOR vs JANUVIA IVACAFTOR\TEZACAFTOR vs JETREA IVACAFTOR\TEZACAFTOR vs JUXTAPID

Official FDA Label for IVACAFTOR\TEZACAFTOR

Official prescribing information from the FDA-approved drug label.