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Ivacaftor Side Effects

The most commonly reported side effects of ivacaftor include infective pulmonary exacerbation of cystic fibrosis, hospitalisation, and cough, based on 33,164 FDA adverse event reports from 2008 to 2025.

Ivacaftor side effects

Percentages show how often each reaction appears relative to total reports for ivacaftor.

1
Infective Pulmonary Exacerbation Of Cystic Fibrosis12.1%3,999
2
Hospitalisation9.1%3,027
3
Cough4.1%1,350
4
Headache3.9%1,294
5
Infection3.9%1,293
6
Cystic Fibrosis3.9%1,277
7
Pneumonia3.6%1,180
8
Dyspnoea3.4%1,115
9
Fatigue2.7%903
10
Pulmonary Function Test Decreased2.6%867
11
Abdominal Pain Upper2.4%786
12
Anxiety2.4%784
13
Malaise2.3%751
14
Rash2.2%745
15
Nausea2.2%730

These are voluntary reports and do not establish that ivacaftor caused these reactions.

Report severity

57.6%Serious19,101 reports
44.5%Hospitalizations14,747 reports
2.3%Fatal769 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ivacaftor drug interactions

Other drugs that appear in adverse event reports alongside ivacaftor. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Elexacaftor-ivacaftor-tezacaftor31.1%10,317
2
Lumacaftor24.3%8,055
3
Aztreonam6.6%2,176
4
Tobramycin2.9%978
5
Dornase-alfa2.4%798
6
Lipase1.0%319
7
Pancrelipase-amylase0.9%285
8
Protease0.9%285
9
Albuterol0.4%122
10
Omeprazole0.3%109
11
Dupilumab0.3%101
12
Azithromycin0.3%89
13
Ciprofloxacin0.2%60
14
Sodium-chloride0.2%52
15
Prednisone0.2%52

Taken alongside

1
Dornase-alfa29.0%9,611
2
Lipase25.1%8,333
3
Pancrelipase-amylase24.6%8,165
4
Protease24.6%8,164
5
Albuterol22.6%7,482
6
Tobramycin12.7%4,198
7
Azithromycin12.4%4,121
8
Fluticasone11.5%3,829
9
Sodium-chloride11.0%3,659
10
Ergocalciferol10.7%3,550
11
Aztreonam8.2%2,724
12
Omeprazole7.7%2,545
13
Insulin5.5%1,822
14
Montelukast-sodium5.4%1,792
15
Budesonide4.8%1,601

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ivacaftor side effects

51.0% of ivacaftor adverse event reports involve female patients and 39.8% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.0%
Male39.8%
Unknown9.2%

Age group

< 21.1%
2–1115.8%
12–1717.1%
18–6463.9%
65+2.2%

What is ivacaftor used for

Conditions and purposes for which patients were taking ivacaftor when the adverse event was reported.

AsthmaAmyloidosisAspergillus InfectionBacterial Disease CarrierBronchiectasisBronchitis ChronicBronchopulmonary AspergillosisBronchopulmonary Aspergillosis AllergicCardiac FailureCftr Gene MutationChronic Hepatitis CChronic SinusitisCystic FibrosisCystic Fibrosis LungChronic Obstructive Pulmonary Disease

Showing 15 of 82 indications

Ivacaftor brand names and reporting trend

Ivacaftor is sold under the brand name Ivacaftor.

Brand names

Ivacaftor575

Quarterly reports (20082025)

2008201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ivacaftor with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.