Kalydeco Side Effects

Generic name: ivacaftor

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Note: This document contains side effect information about ivacaftor. Some dosage forms listed on this page may not apply to the brand name Kalydeco.

Applies to ivacaftor: oral granule, oral tablet.

Serious side effects of Kalydeco

Along with its needed effects, ivacaftor (the active ingredient contained in Kalydeco) 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:

More common

Body aches or pain
chest pain
chills
cough
difficulty with breathing or trouble breathing
ear congestion
fever
headache
loss of voice
runny or stuffy nose
sneezing
sore throat
unusual tiredness or weakness

Less common

Dark urine
fever with or without chills
light-colored stools
loss of appetite
nausea
stomach pain
vomiting
yellow eyes or skin

incidence not known

Chest tightness
difficulty swallowing
dizziness
fast heartbeat
hives, itching, skin rash
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects of Kalydeco

Some side effects of ivacaftor 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

Blemishes on the skin
diarrhea
difficulty with moving
muscle aches, pain, or stiffness
pain in the joints
pimples
rash

For Healthcare Professionals

Applies to ivacaftor: oral granule for reconstitution, oral tablet.

Dermatologic

Very common (10% or more): Rash (up to 13%)

Common (1% to 10%): Acne^[Ref]

Gastrointestinal

Very common (10% or more): Oropharyngeal pain (22%), abdominal pain (16%), diarrhea (13%), nausea (12%)^[Ref]

Hepatic

Very Common (10% or more): Transaminase elevations (up to 27.8%)

Common (1% to 10%): Increased aspartate aminotransferase, increased hepatic enzymes, transaminase elevations^[Ref]

Maximum transaminase (ALT or AST) levels of greater than 8 times upper limit of normal (ULN), greater than 5 times ULN, and greater than 3 times ULN were reported in 2%, 3%, and 6% of patients treated with ivacaftor, respectively.

In patients aged 12 months to less than 24 months (N=19), the incidence transaminase elevations (ALT or AST) greater than 3, greater than 5, and greater than 8 times the upper limit of normal (x ULN) was 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18), respectively. In patients aged 6 months to less than 12 months (N=11) one patient (9.1%) had elevated ALT of greater than 3 to less than or equal to 5 x ULN. No patients had elevations in total bilirubin, or discontinued ivacaftor treatment due to transaminase elevations.^[Ref]

Metabolic

Common (1% to 10%): Increased blood glucose^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, musculoskeletal chest pain, myalgia^[Ref]

Nervous system

Very common (10% or more): Headache (24%)

Common (1% to 10%): Dizziness, sinus headache^[Ref]

Other

Very common (10% or more): Pyrexia (14.7%)

Common (1% to 10%): Bacteria in sputum, ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, ear congestion^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (22%), nasal congestion (20%), nasopharyngitis (15%), cystic fibrosis lung (38.5%), cough (36.7%), productive cough (12.8%), rales (10%)

Common (1% to 10%): Rhinitis, pharyngeal erythema, pleuritic pain, sinus congestion, wheezing^[Ref]