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.
Common side effects of Kalydeco include: dizziness. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to ivacaftor: oral granule, oral tablet
Side effects requiring immediate medical attention
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:
- Body aches or pain
- chest pain
- difficulty with breathing or troubled breathing
- ear congestion
- loss of voice
- runny or stuffy nose
- sore throat
- unusual tiredness or weakness
- Dark urine
- fever with or without chills
- light-colored stools
- loss of appetite
- stomach pain
- yellow eyes or skin
Side effects not requiring immediate medical attention
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:
- Blemishes on the skin
- difficulty with moving
- muscle aches, pain, or stiffness
- pain in the joints
For Healthcare Professionals
Applies to ivacaftor: oral granule for reconstitution, oral tablet
Very common (10% or more): Rash (up to 13%)
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]
Common (1% to 10%): Increased blood glucose[Ref]
Common (1% to 10%): Arthralgia, musculoskeletal chest pain, myalgia[Ref]
Very common (10% or more): Headache (24%)
Common (1% to 10%): Dizziness, sinus headache[Ref]
Very common (10% or more): Pyrexia (14.7%)
Common (1% to 10%): Breast mass
Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain[Ref]
Postmarketing reports: Non-congenital lens opacities/cataracts (in pediatric patients up to 12 years of age)[Ref]
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Kalydeco (ivacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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More about Kalydeco (ivacaftor)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- 1 Review
- Drug class: CFTR potentiators
- FDA Approval History