Ceritinib Side Effects

In Summary

Commonly reported side effects of ceritinib include: abdominal pain, diarrhea, hyperglycemia, increased serum alanine aminotransferase, nausea, and vomiting. Other side effects include: interstitial pulmonary disease, pneumonitis, and prolonged qt interval on ecg. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ceritinib: oral capsule

Along with its needed effects, ceritinib 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 ceritinib:

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clay colored stools
• dark urine
• decreased appetite
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• nausea and vomiting
• skin rash or itching
• stomach pain or tenderness
• sweating
• swelling of the feet or lower legs
• troubled breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

• Chest pain
• chills
• cough
• fainting
• general feeling of discomfort or illness
• irregular heartbeat, recurrent
• thickening of bronchial secretions

Some side effects of ceritinib 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:

• Blurred vision or other changes in vision
• decreased appetite
• diarrhea
• difficulty having a bowel movement
• heartburn
• pain or discomfort in the chest, upper stomach, or throat
• seeing flashes or sparks of light

For Healthcare Professionals

Applies to ceritinib: oral capsule

General

The most common side effect resulting in dose reductions or interruptions were increased ALT (29%), nausea (20%), increased AST (16%), diarrhea (16%), and vomiting (16%).

The most common side effects leading to discontinuation were pneumonia, interstitial lung disease/pneumonitis, and decreased appetite.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (86%), nausea (80%), vomiting (60%), abdominal pain (54%), constipation (29%), esophageal disorder (16%)
Rare (less than 0.1%): Gastrointestinal hemorrhage^[Ref]

Hematologic

Very Common (10% or more): Hemoglobin decreased (84%), phosphate decreased (36%)^[Ref]

Hepatic

Very Common (10% or more): ALT increased (80%), AST increased (75%), bilirubin increased (15%)^[Ref]

Renal

Very Common (10% or more): Creatinine increased (58%), phosphate decreased (36%)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (34%), glucose increased (49%), lipase increased (28%)^[Ref]

Dermatologic

Very common (10% or more): Rash (16%)^[Ref]

Respiratory

Common (1% to 10%): Interstitial lung disease/pneumonitis
Rare (0.01% than 0.1%): Respiratory failure, pneumothorax, pulmonary tuberculosis^[Ref]

Nervous system

Very common (10% or more): Neuropathy (17%)^[Ref]

Ocular

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

Cardiovascular

Common (1% to 10%): Prolonged QT, bradycardia
Rare (less than 0.1%): Cardiac tamponade^[Ref]

Other

Very common (10% or more): Fatigue (52%)
Uncommon (0.1% to 1%): General physical health deterioration
Rare (less than 0.1%): Sepsis^[Ref]

Some side effects of ceritinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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