OpenClaim

Elexacaftor Side Effects

The most commonly reported side effects of elexacaftor include infective pulmonary exacerbation of cystic fibrosis, headache, and cough, based on 11,913 FDA adverse event reports from 2008 to 2025.

Elexacaftor side effects

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

1
Infective Pulmonary Exacerbation Of Cystic Fibrosis6.5%778
2
Headache6.3%747
3
Cough4.9%580
4
Anxiety4.8%575
5
Rash4.7%560
6
Productive Cough4.4%519
7
Fatigue4.3%513
8
Weight Increased4.2%497
9
Cystic Fibrosis4.0%476
10
Abdominal Pain Upper3.9%460
11
Depression3.5%419
12
Hospitalisation3.4%405
13
Pneumonia3.2%379
14
Diarrhoea3.1%375
15
Infection2.8%329

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

Report severity

41.6%Serious4,951 reports
27.5%Hospitalizations3,275 reports
1.9%Fatal223 reports

Seriousness is determined by the reporter, not by OpenClaim.

Elexacaftor drug interactions

Other drugs that appear in adverse event reports alongside elexacaftor. 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
Ivacaftor86.6%10,322
2
Aztreonam11.3%1,345
3
Tobramycin2.2%257
4
Dornase-alfa2.1%255
5
Lipase0.8%98
6
Pancrelipase-amylase0.8%98
7
Protease0.8%98
8
Dupilumab0.8%90
9
Albuterol0.2%27
10
Prednisone0.2%27
11
Azithromycin0.2%25
12
Amikacin-sulfate0.2%24
13
Tezacaftor0.2%20
14
Insulin0.2%19
15
Sodium-chloride0.2%18

Taken alongside

1
Dornase-alfa26.4%3,141
2
Lipase24.3%2,890
3
Pancrelipase-amylase23.8%2,835
4
Protease23.8%2,835
5
Albuterol22.6%2,693
6
Ivacaftor13.2%1,575
7
Sodium-chloride12.3%1,470
8
Azithromycin12.1%1,443
9
Tobramycin11.8%1,409
10
Ergocalciferol11.6%1,379
11
Fluticasone11.3%1,343
12
Omeprazole7.2%857
13
Aztreonam7.1%845
14
Insulin6.1%726
15
Budesonide5.7%680

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 elexacaftor side effects

49.6% of elexacaftor adverse event reports involve female patients and 35.7% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.6%
Male35.7%
Unknown14.7%

Age group

< 20.9%
2–1110.8%
12–1716.1%
18–6469.0%
65+3.2%

What is elexacaftor used for

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

AmyloidosisBacterial Disease CarrierBronchiectasisCftr Gene MutationChronic SinusitisCystic FibrosisCystic Fibrosis LungCystic FibrosisCystic Fibrosis LungCytogenetic AbnormalityDiabetes MellitusDrug Use For Unknown IndicationDrug TherapyDyspnoeaForced Expiratory Volume Decreased

Showing 15 of 36 indications

Elexacaftor brand names and reporting trend

Elexacaftor is sold under the brand name Trikafta (copackaged).

Brand names

Trikafta (copackaged)42

Quarterly reports (20082025)

200820202025

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

Taking elexacaftor with another medication?

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