Kalydeco Side Effects

Generic Name: ivacaftor

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

Some side effects of Kalydeco may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ivacaftor: oral tablet

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 troubled breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Dark urine
  • fever with or without chills
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • stomach pain
  • yellow eyes or skin

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
  • muscle pain or stiffness
  • pain in the joints
  • pimples
  • rash

For Healthcare Professionals

Applies to ivacaftor: oral tablet


Dermatologic side effects have included rash (13%) and acne.


Gastrointestinal side effects have included oropharyngeal pain (22%), abdominal pain (16%), nausea (13%), and diarrhea (13%).


Hepatic side effects have included transaminase elevations.


Metabolic side effects have included increased blood glucose.


Musculoskeletal side effects have included arthralgia, musculoskeletal chest pain, and myalgia.

Nervous system

Nervous system side effects have included headache (24%), dizziness (9%), and sinus headache.


Other side effects have included increased aspartate aminotransferase, increased hepatic enzymes, and bacteria in sputum.


Respiratory side effects have included upper respiratory tract infection (22%), nasal congestion (20%), nasopharyngitis (15%), rhinitis (4 to 7%), pharyngeal erythema, pleuritic pain, sinus congestion, and wheezing.

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