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Ivacaftor / lumacaftor Side Effects

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ivacaftor / lumacaftor: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ivacaftor / lumacaftor. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking ivacaftor / lumacaftor:

More common:
  • Difficult or labored breathing
  • tightness in the chest
Incidence not known:
  • Blurred vision
  • dark urine
  • dizziness
  • headache
  • loss of appetite
  • nausea and vomiting
  • nervousness
  • pain or discomfort in upper right stomach area
  • pounding in the ears
  • slow or fast heartbeat
  • unusual tiredness
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with ivacaftor / lumacaftor may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Absent, missed, or irregular menstrual periods
  • bloated
  • body aches or pain
  • chills
  • cough
  • cramps
  • diarrhea
  • ear congestion
  • excess air or gas in the stomach or intestines
  • fever
  • full feeling
  • heavy bleeding
  • longer or heavier menstrual periods
  • loss of voice
  • muscle aches
  • passing gas
  • rash
  • sneezing
  • sore throat
  • stopping of menstrual bleeding
  • stuffy or runny nose
  • unusual weakness

For Healthcare Professionals

Applies to ivacaftor / lumacaftor: 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[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]

References

1. "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Not all side effects for ivacaftor / lumacaftor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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