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

Summary

Common side effects of Kalydeco include: dizziness. Continue reading for a comprehensive list of adverse effects.

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

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
• dizziness
• 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

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 (the active ingredient contained in Kalydeco) 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]

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

Common (1% to 10%): Increased aspartate aminotransferase, increased hepatic enzymes, 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]

Endocrine

Common (1% to 10%): Breast mass

Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain^[Ref]

Ocular

Postmarketing reports: Non-congenital lens opacities/cataracts (in pediatric patients up to 12 years of age)^[Ref]