OpenClaim

Tezacaftor Side Effects

The most commonly reported side effects of tezacaftor include rash, diarrhoea, and infective pulmonary exacerbation of cystic fibrosis, based on 452 FDA adverse event reports from 2017 to 2025. 2.4% of reports found the drug to be ineffective.

Tezacaftor side effects

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

1
Rash7.3%33
2
Diarrhoea6.2%28
3
Infective Pulmonary Exacerbation Of Cystic Fibrosis6.2%28
4
Liver Function Test Increased6.0%27
5
Headache5.5%25
6
Anxiety5.5%25
7
Fatigue4.9%22
8
Dyspnoea4.0%18
9
Cough3.8%17
10
Productive Cough3.3%15
11
Drug Interaction3.3%15
12
Hospitalisation3.1%14
13
Haemoptysis2.9%13
14
Nausea2.9%13
15
Pyrexia2.7%12

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

Report severity

45.8%Serious207 reports
27.0%Hospitalizations122 reports
0.9%Fatal4 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tezacaftor drug interactions

Other drugs that appear in adverse event reports alongside tezacaftor. 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
Deutivacaftor69.2%313
2
Vanzacaftor-calcium69.2%313
3
Aztreonam11.5%52
4
Tobramycin10.4%47
5
Ivacaftor7.3%33
6
Elexacaftor-ivacaftor-tezacaftor4.6%21
7
Albuterol3.3%15
8
Lipase2.7%12
9
Pancrelipase-amylase2.7%12
10
Protease2.7%12
11
Levothyroxine-sodium2.2%10
12
Dornase-alfa2.0%9
13
Colistimethate-sodium2.0%9
14
Ferrous-fumarate2.0%9
15
Pantoprazole-sodium2.0%9

Taken alongside

1
Dornase-alfa14.6%66
2
Lipase11.5%52
3
Ivacaftor11.3%51
4
Albuterol11.3%51
5
Pancrelipase-amylase11.1%50
6
Protease11.1%50
7
Azithromycin6.9%31
8
Sodium-chloride5.8%26
9
Deutivacaftor5.8%26
10
Vanzacaftor-calcium5.8%26
11
Fluticasone5.1%23
12
Tobramycin5.1%23
13
Ergocalciferol4.4%20
14
Elexacaftor-ivacaftor-tezacaftor4.4%20
15
Omeprazole4.0%18

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 tezacaftor side effects

46.2% of tezacaftor adverse event reports involve female patients and 24.8% involve male patients. The largest age group is adult at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female46.2%
Male24.8%
Unknown29.0%

Age group

< 21.1%
2–118.7%
12–1715.6%
18–6472.1%
65+2.5%

What is tezacaftor used for

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

Cftr Gene MutationCystic FibrosisCystic FibrosisCystic Fibrosis LungHaemoptysisImmunomodulatory TherapyInfective Pulmonary Exacerbation Of Cystic FibrosisLiver TransplantMaternal Exposure Timing UnspecifiedOedemaProduct Used For Unknown IndicationPseudomonas InfectionPancreatic FailureProduct Used For Unknown IndicationSkin Cosmetic Procedure

Tezacaftor brand names and reporting trend

Tezacaftor is sold under the brand name Alyftrek.

Brand names

Alyftrek130

Quarterly reports (20172025)

201720242025

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

Taking tezacaftor with another medication?

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