Kalydeco Side Effects

Generic Name: ivacaftor

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

Not all side effects for Kalydeco may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ivacaftor: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ivacaftor (the active ingredient contained in Kalydeco). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with ivacaftor may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Very common (10% or more): Rash (up to 13%)
Common (1% to 10%): Acne

Gastrointestinal

Very common (10% or more): Abdominal pain (16%), diarrhea (13%), nausea (up to 12%)

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.

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

Metabolic

Common (1% to 10%): Increased blood glucose

Musculoskeletal

Common (1% to 10%): Arthralgia, musculoskeletal chest pain, myalgia

Nervous system

Very common (10% or more): Headache (up to 24%)
Common (1% to 10%): Dizziness, sinus headache

Other

Common (1% to 10%): Bacteria in sputum

Respiratory

Very common (10% or more): Oropharyngeal pain (22%), upper respiratory tract infection (up to 22%), nasal congestion (up to 20%), nasopharyngitis (15%)
Common (1% to 10%): Rhinitis, pharyngeal erythema, pleuritic pain, sinus congestion, wheezing

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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