Ivacaftor / lumacaftor Side Effects
Medically reviewed by Drugs.com. Last updated on May 7, 2023.
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
- difficulty swallowing
- discomfort in the upper right stomach area
- dizziness
- fast heartbeat
- general feeling of tiredness or weakness
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- nausea
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- 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]
Frequently asked questions
More about ivacaftor / lumacaftor
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: CFTR combinations
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Orkambi (ivacaftor-lumacaftor). Vertex Pharmaceuticals. 2015.
Further information
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.
