Deutivacaftor / Tezacaftor / Vanzacaftor Side Effects
Applies to deutivacaftor / tezacaftor / vanzacaftor: oral tablet.
Important warnings
This medicine can cause some serious health issues
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:
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blurred vision, seeing halos around lights; or
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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:
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rash;
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abnormal liver function tests;
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nose or throat swelling;
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mouth, throat, or nose pain; or
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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.
See also:
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
Nervous system
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]
References
1. (2024) "Product Information. Alyftrek (deutivacaftor / tezacaftor / vanzacaftor)." Vertex Pharmaceuticals
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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.