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. Continue reading for a comprehensive list of adverse effects.

Applies to ceritinib: oral tablet.

Serious side effects of Ceritinib

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:

More common

• 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
• itching, skin rash
• loss of appetite
• nausea
• stomach pain or tenderness
• sweating
• swelling of the feet or lower legs
• trouble breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

Less common

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

Other side effects of Ceritinib

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:

More common

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

Incidence not known

• Increased sensitivity of the skin to sunlight
• redness or other discoloration of the skin
• severe sunburn

For Healthcare Professionals

Applies to ceritinib: oral capsule, oral tablet.

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%): GI 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^[Ref]

Immunologic

Rare (less than 0.1%): Sepsis^[Ref]