Kalydeco Side Effects

Generic name: ivacaftor

Medically reviewed by Drugs.com. Last updated on Jun 18, 2024.

Note: This document provides detailed information about Kalydeco.

Applies to ivacaftor: oral granule, oral tablet Side Effects associated with ivacaftor. Some dosage forms listed on this page may not apply specifically to the brand name Kalydeco.

Applies to ivacaftor: oral granule, oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

For healthcare professionals

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

Dermatologic adverse events

• 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]

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]

See also:

Frequently asked questions

• How does Kalydeco work?
• What is the difference between Symdeko and Orkambi?
• What is the difference between Symdeko and Kalydeco?
• What is an orphan drug?

Further information

Kalydeco 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