OpenClaim

Vanzacaftor Side Effects

The most commonly reported side effects of vanzacaftor include rash, liver function test increased, and anxiety, based on 339 FDA adverse event reports from 2017 to 2025.

Vanzacaftor side effects

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

1
Rash8.6%29
2
Liver Function Test Increased7.1%24
3
Anxiety6.5%22
4
Diarrhoea6.2%21
5
Headache5.9%20
6
Fatigue5.0%17
7
Hospitalisation4.1%14
8
Infective Pulmonary Exacerbation Of Cystic Fibrosis3.8%13
9
Nausea3.5%12
10
Abdominal Pain Upper2.9%10
11
Gastrointestinal Disorder2.7%9
12
Abdominal Distension2.7%9
13
Insomnia2.7%9
14
Depression2.7%9
15
Alanine Aminotransferase Increased2.7%9

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

Report severity

33.3%Serious113 reports
16.8%Hospitalizations57 reports
0.6%Fatal2 reports

Seriousness is determined by the reporter, not by OpenClaim.

Vanzacaftor drug interactions

Other drugs that appear in adverse event reports alongside vanzacaftor. 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
Deutivacaftor92.3%313
2
Tezacaftor92.3%313
3
Aztreonam7.1%24
4
Elexacaftor-ivacaftor-tezacaftor2.9%10
5
Ivacaftor2.9%10
6
Dupilumab2.7%9
7
Dornase-alfa1.5%5
8
Abatacept0.9%3
9
Albuterol0.9%3
10
Benralizumab0.9%3
11
Insulin0.6%2
12
Lipase0.6%2
13
Pancrelipase-amylase0.6%2
14
Protease0.6%2
15
Pregabalin0.6%2

Taken alongside

1
Lipase10.0%34
2
Pancrelipase-amylase9.4%32
3
Protease9.4%32
4
Dornase-alfa8.6%29
5
Albuterol8.6%29
6
Deutivacaftor7.7%26
7
Tezacaftor7.7%26
8
Tobramycin5.0%17
9
Sodium-chloride5.0%17
10
Azithromycin3.8%13
11
Ergocalciferol3.5%12
12
Fluticasone3.2%11
13
Famotidine2.7%9
14
Formoterol2.7%9
15
Aztreonam2.4%8

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 vanzacaftor side effects

47.5% of vanzacaftor adverse event reports involve female patients and 23.9% involve male patients. The largest age group is adult at 71%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.5%
Male23.9%
Unknown28.6%

Age group

< 20.0%
2–118.6%
12–1717.3%
18–6470.6%
65+3.6%

What is vanzacaftor used for

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

Cystic FibrosisCystic Fibrosis LungProduct Used For Unknown IndicationSkin Cosmetic Procedure

Vanzacaftor brand names and reporting trend

Quarterly reports (20172025)

20172025

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

Taking vanzacaftor with another medication?

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