Elexacaftor / Ivacaftor / Tezacaftor Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 17, 2025.

Applies to elexacaftor / ivacaftor / tezacaftor: 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.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your child's 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.

Other side effects

Some side effects of elexacaftor / ivacaftor / tezacaftor 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:

Serious side effects

Along with its needed effects, elexacaftor/ivacaftor/tezacaftor 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 elexacaftor/ivacaftor/tezacaftor:

For healthcare professionals

Applies to elexacaftor / ivacaftor / tezacaftor: oral granule, oral tablet.

General adverse events

The most commonly reported adverse reactions in 5% of patients or greater included headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, increased blood creatine phosphokinase, increased aspartate aminotransferase, rhinorrhea, rhinitis, influenza, sinusitis, and increased blood bilirubin. The safety profile was generally consistent among pediatric and adult patients.^[Ref]

Cardiovascular

• Common (1% to 10%): Elevated blood pressure

Dermatologic

• Common (1% to 10%): Rash, acne, eczema, pruritus

Rash includes generalized rash, erythematous rash, macular rash, and pruritic rash.

Gastrointestinal

• Very common (10% or more): Upper, lower, and general abdominal pain (up to 14%), diarrhea (up to 13%)
• Common (1% to 10%): Flatulence, abdominal distension

Genitourinary

• Common (1% to 10%): Dysmenorrhea, urinary tract infection

Hepatic

• Very common (10% or more): Increased ALT (up to 10%)
• Common (1% to 10%): Increased AST, increased bilirubin levels

Postmarketing report: Liver failure leading to transplantation, liver injury characterized by concomitant transaminase and total bilirubin elevations

Hypersensitivity

• Postmarketing reports: Hypersensitivity reactions (angioedema and anaphylaxis)

Metabolic

• Common (1% to 10%): Hypoglycemia

Musculoskeletal

• Common (1% to 10%): Increased creatine phosphokinase

Nervous system

• Very common (10% or more): Headache (17%)
• Common (1% to 10%): Dizziness

Ocular

Elexacaftor / ivacaftor / tezacaftor:

• Common (1% to 10%): Conjunctivitis

Ivacaftor-Containing Regimens:

• Frequency not reported: Non-congenital lens opacities/cataracts (pediatric patients)

Other

• Common (1% to 10%): Increased C-reactive protein, influenza, ear pain, ear discomfort, tinnitus, tympanic membrane hyperemia, vestibular disorder, breast mass
• Uncommon (0.1% to 1%): Ear congestion, breast inflammation, gynecomastia, nipple disorder, nipple pain

Respiratory

• Very common (10% or more): Infective pulmonary exacerbation of cystic fibrosis (up to 21.8%), sputum increased (up to 19.8%), cough (up to 16.8%), upper respiratory tract infection (up to 16%), bacteria in sputum (greater than 10%)
• Common (1% to 10%): Nasal congestion, rhinorrhea, rhinitis, sinusitis, pharyngitis, respiratory tract infection, tonsillitis, hemoptysis, oropharyngeal pain, nasopharyngitis, pharyngeal erythema, abnormal breathing
• Uncommon (0.1% to 1%): Wheezing

See also:

Frequently asked questions

• What is Trikafta?

Further information

Elexacaftor/ivacaftor/tezacaftor 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