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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\LUMACAFTOR: 8,110 Adverse Event Reports & Safety Profile

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8,110
Total FAERS Reports
142 (1.8%)
Deaths Reported
4,157
Hospitalizations
8,110
As Primary/Secondary Suspect
26
Life-Threatening
8
Disabilities

First Report: 20121212 · Latest Report: 20250811

What Are the Most Common IVACAFTOR\LUMACAFTOR Side Effects?

#1 Most Reported
Infective pulmonary exacerbation of cystic fibrosis
1,417 reports (17.5%)
#2 Most Reported
Hospitalisation
859 reports (10.6%)
#3 Most Reported
Dyspnoea
528 reports (6.5%)

All IVACAFTOR\LUMACAFTOR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infective pulmonary exacerbation of cystic fibrosis 1,417 17.5% 26 1,212
Hospitalisation 859 10.6% 6 845
Dyspnoea 528 6.5% 1 211
Pulmonary function test decreased 378 4.7% 2 263
Cough 363 4.5% 1 127
Infection 343 4.2% 2 190
Chest discomfort 335 4.1% 1 84
Cystic fibrosis 254 3.1% 10 221
Pneumonia 233 2.9% 4 196
Malaise 219 2.7% 3 106
Nasopharyngitis 199 2.5% 1 63
Respiration abnormal 191 2.4% 1 88
Fatigue 190 2.3% 0 68
Diarrhoea 186 2.3% 0 47
Influenza 178 2.2% 2 88
Nausea 175 2.2% 0 55
Pyrexia 159 2.0% 2 88
Cystic fibrosis respiratory infection suppression 144 1.8% 0 143
Vomiting 144 1.8% 0 52
Headache 137 1.7% 0 31

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

Gender: 52.4% female, 47.6% male. Average age: 19.8 years. Most reports from: US. View detailed demographics →

Is IVACAFTOR\LUMACAFTOR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 0
2013 1 0 0
2014 6 0 3
2015 557 11 261
2016 1,025 34 643
2017 1,178 18 742
2018 1,192 23 740
2019 1,384 9 799
2020 300 0 149
2021 67 1 42
2022 70 2 45
2023 39 2 20
2024 27 0 9
2025 6 0 5

View full timeline →

What Is IVACAFTOR\LUMACAFTOR Used For?

IndicationReports
Cystic fibrosis 7,864
Product used for unknown indication 33
Pseudomonas infection 8

IVACAFTOR\LUMACAFTOR vs Alternatives: Which Is Safer?

IVACAFTOR\LUMACAFTOR vs IVACAFTOR\TEZACAFTOR IVACAFTOR\LUMACAFTOR vs IVERMECTIN IVACAFTOR\LUMACAFTOR vs IVOSIDENIB IVACAFTOR\LUMACAFTOR vs IXABEPILONE IVACAFTOR\LUMACAFTOR vs IXAZOMIB IVACAFTOR\LUMACAFTOR vs IXEKIZUMAB IVACAFTOR\LUMACAFTOR vs JAKAFI IVACAFTOR\LUMACAFTOR vs JAKAVI IVACAFTOR\LUMACAFTOR vs JANUMET IVACAFTOR\LUMACAFTOR vs JANUVIA

Official FDA Label for IVACAFTOR\LUMACAFTOR

Official prescribing information from the FDA-approved drug label.