Applies to ivacaftor / tezacaftor: oral tablet.
Serious side effects
Along with its needed effects, ivacaftor/tezacaftor may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ivacaftor / tezacaftor:
Rare
- Nausea
- severe constipation
- stomach pain
- vomiting
Incidence not known
- Blindness
- blurred vision
- dark urine
- decreased vision
- light-colored stools
- loss of appetite
- yellow skin or eyes
Other side effects
Some side effects of ivacaftor / tezacaftor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Headache
Less common
- Dizziness
- stuffy nose
For Healthcare Professionals
Applies to ivacaftor / tezacaftor: oral tablet.
General
The most commonly reported side effects have included headache, nasopharyngitis, nausea, sinus congestion, and dizziness.[Ref]
Nervous system
Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness
Ocular
Frequency not reported: Non-congenital lens opacities
Respiratory
Common (1% to 10%): Sinus congestion
Gastrointestinal
Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Distal intestinal obstruction syndrome
Hepatic
Common (1% to 10%): Transaminase elevations
The incidence of maximum transaminase (ALT or AST) elevations to greater than 8 times the upper limit of normal (8 x ULN), greater than 5 x ULN, or greater than 3 x ULN was similar between drug treated and placebo treated patients (0.2%, 1%, 3.4% versus 0.4%, 1%, 3.4%, respectively). A total of 3 patients in clinical trials permanently discontinued therapy due to elevated transaminases (1 drug treated and 2 on placebo). No drug-treated patient experienced a transaminase elevation greater than 3 x ULN associated with elevated total bilirubin greater than 2 x ULN.
