Summary

Commonly reported side effects of ivacaftor/lumacaftor include: upper respiratory tract infection, dyspnea, chest discomfort, nausea, and skin rash. Other side effects include: influenza, and flatulence. Continue reading for a comprehensive list of adverse effects.

Applies to ivacaftor / lumacaftor: oral granule, oral tablet.

Serious side effects

Along with its needed effects, ivacaftor/lumacaftor 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 / lumacaftor:

More common

• Body aches or pain
• chest tightness
• chills
• cough
• difficult or labored breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness
• upper abdominal or stomach pain

Incidence not known

• Blurred vision
• dark urine
• discomfort in the upper right stomach area
• dizziness
• general feeling of tiredness or weakness
• light-colored stools
• loss of appetite
• nausea
• nervousness
• pounding in the ears
• slow or fast heartbeat
• stomach pain, continuing
• vomiting
• yellow eyes or skin

Other side effects

Some side effects of ivacaftor / lumacaftor 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

• Absent, missed, or irregular menstrual periods
• bloated feeling
• cough producing mucus
• cramps
• diarrhea
• excess air or gas in the stomach or bowels
• feeling of fullness
• heavy bleeding
• increased sputum production
• longer or heavier menstrual periods
• loss of voice
• passing gas
• rash
• stopping of menstrual bleeding

For Healthcare Professionals

Applies to ivacaftor / lumacaftor: oral granule for reconstitution, oral tablet.

General

The most frequently reported side effects were dyspnea, nasopharyngitis, nausea, diarrhea, upper respiratory tract infection, fatigue, respiration abnormal, blood creatine phosphokinase increased, rash, flatulence, rhinorrhea, and influenza.^[Ref]

Respiratory

Very common (10% or more): Infective pulmonary exacerbation of cystic fibrosis (37.5%), cough (30.5%), sputum increased (14.8 %), dyspnea (up to 14%), hemoptysis (13.8%), nasopharyngitis (up to 13%), upper respiratory tract infection (up to 10%)

Common (1% to 10%): Rhinitis, pharyngeal erythema, sinus congestion, respiration abnormal, rhinorrhea, nasal congestion

Ivacaftor:

Very common (10% or more): Nasopharyngitis, nasal congestion

Common (1% to 10%): Sinus congestion, pharyngeal erythema^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13%), diarrhea (up to 12%), abdominal pain

Common (1% to 10%): Flatulence, oropharyngeal pain, vomiting

Ivacaftor:

Very common (10% or more): Abdominal pain^[Ref]

Dermatologic

Common (1% to 10%): Rash^[Ref]

Nervous system

Very common (10% or more): Headache (up to 15.7%), dizziness

Ivacaftor:

Very common (10% or more): Dizziness, headache^[Ref]

Other

Very common (10% or more): Bacteria in sputum

Common (1% to 10%): Blood creatine phosphokinase increased, fatigue, influenza, ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, vestibular disorder, chest discomfort

Uncommon (0.1% to 1%): Ear congestion

Ivacaftor:

Very common (10% or more): Bacteria in sputum

Common (1% to 10%): Ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, vestibular disorder

Uncommon (0.1% to 1%): Ear congestion^[Ref]

Endocrine

Very common (10% or more): Breast mass

Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain

Ivacaftor:

Common (1% to 10%): Breast mass

Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain^[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased/hypertension^[Ref]

Hepatic

Common (1% to 10%): AST increased, ALT increased

Uncommon (0.1% to 1%): Hepatic encephalopathy, cholestatic hepatitis

Frequency not reported: Total bilirubin increased

Postmarketing reports: Liver failure leading to death, liver function decompensation^[Ref]

Genitourinary

Common (1% to 10%): Menstruation abnormal/irregular, dysmenorrhea, metrorrhagia, amenorrhea, menorrhagia

Uncommon (0.1% to 1%): Oligomenorrhea, polymenorrhea^[Ref]

Ocular

Frequency not reported: Non-congenital lens opacities^[Ref]