Ivacaftor (Oral Route)

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Side Effects

Along with its needed effects, a medicine 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:

• Body aches or pain
• Chest pain
• Chills
• Cough
• Difficulty with breathing or troubled breathing
• Ear congestion
• Fever
• Headache
• Loss of voice
• Nasal congestion
• Runny nose
• Sneezing
• Sore throat
• Unusual tiredness or weakness

• Dark urine
• Fever with or without chills
• Light-colored stools
• Loss of appetite
• Nausea and vomiting
• Stomach pain
• Yellow eyes or skin

Some side effects 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:

• Blemishes on the skin
• Diarrhea
• Difficulty with moving
• Dizziness
• Muscle aches
• Muscle pain or stiffness
• Pain in the joints
• Pimples
• Rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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