Elexacaftor / Ivacaftor / Tezacaftor Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 23, 2025.

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

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:

More common side effects

• body aches or pain
• chills
• diarrhea
• ear congestion
• fever
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose

Less common side effects

• anxiety
• bladder pain
• blemishes on the skin
• bloated
• bloody or cloudy urine
• blurred vision
• burning, dry, or itching eyes
• cold sweats
• coma
• confusion
• cool, pale skin
• cramps
• depression
• difficult, burning, or painful urination
• discharge, excessive tearing
• excess air or gas in the stomach or intestines
• fast heartbeat
• frequent urge to urinate
• full feeling
• heavy bleeding
• increased hunger
• lower back or side pain
• nervousness
• nightmares
• pain
• passing gas
• pimples
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• seizures
• shakiness
• skin rash, encrusted, scaly, and oozing
• slurred speech

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:

Incidence not known

• chest tightness
• cough
• dark urine
• difficulty swallowing
• dizziness
• fast heartbeat
• headache
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stomach pain or bloating
• trouble breathing
• yellow eyes or skin
• unusual tiredness or weakness

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

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