Deutivacaftor / Tezacaftor / Vanzacaftor Side Effects

Applies to deutivacaftor / tezacaftor / vanzacaftor: oral tablet.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blurred vision, seeing halos around lights; or

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache, tiredness, cough;

• rash;

• abnormal liver function tests;

• nose or throat swelling;

• mouth, throat, or nose pain; or

• flu, cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to deutivacaftor / tezacaftor / vanzacaftor: oral tablet.

General adverse events

Most frequently reported adverse reactions were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST, and sinus congestion.^[Ref]

Cardiovascular

• Common (1% to 10%): Increased systolic and diastolic blood pressure^[Ref]

Dermatologic

• Very common (10% or more): Rash (includes pruritic rash) (up to 11%)^[Ref]

Gastrointestinal

• Frequency not reported: Abdominal pain, constipation, diarrhea, nausea, vomiting^[Ref]

Hepatic

• Common (1% to 10%): Transaminase elevations (ALT or AST)
• Uncommon (0.1% to 1%): Increased GGT^[Ref]

Musculoskeletal

• Frequency not reported: Arthralgia, back pain^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 16%)
• Uncommon (0.1% to 1%): Syncope^[Ref]

Other

• Very common (10% or more): Fatigue (up to 11%)
• Frequency not reported: Pyrexia^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Depression^[Ref]

Renal

• Frequency not reported: Increased blood creatinine phosphokinase^[Ref]

Respiratory

• Very common (10% or more): Cough (productive cough) (up to 25%), nasopharyngitis (up to 21%), upper respiratory tract infection (viral) (up to 21%), oropharyngeal pain (up to 14%), influenza (up to 11%)
• Common (1% to 10%): Sinus congestion
• Frequency not reported: COVID-19, dyspnea, hemoptysis, infective pulmonary exacerbation of cystic fibrosis, increased sputum, nasal congestion, rhinorrhea^[Ref]

See also:

Further information

Deutivacaftor/tezacaftor/vanzacaftor side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer