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Orkambi Side Effects

Generic name: ivacaftor / lumacaftor

Medically reviewed by Drugs.com. Last updated on Jul 22, 2024.

Note: This document provides detailed information about Orkambi Side Effects associated with ivacaftor / lumacaftor. Some dosage forms listed on this page may not apply specifically to the brand name Orkambi.

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

Serious side effects of Orkambi

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 of Orkambi

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

Ivacaftor:

Gastrointestinal

Ivacaftor:

Dermatologic

Nervous system

Ivacaftor:

Other

Ivacaftor:

Endocrine

Ivacaftor:

Cardiovascular

Hepatic

Genitourinary

Ocular

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2015) "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals

Frequently asked questions

Further information

Orkambi 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.

Some side effects may not be reported. You may report them to the FDA.