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Xalkori Side Effects

Generic Name: crizotinib

Note: This document contains side effect information about crizotinib. Some of the dosage forms listed on this page may not apply to the brand name Xalkori.

For the Consumer

Applies to crizotinib: oral capsule

Along with its needed effects, crizotinib (the active ingredient contained in Xalkori) 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 crizotinib:

More common
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • cough or hoarseness
  • difficult or labored breathing
  • ear congestion
  • fever or chills
  • headache
  • increased sensitivity to pain or touch
  • lightheadedness, dizziness, or fainting
  • loss of voice
  • lower back or side pain
  • nerve pain
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • slow or irregular heartbeat
  • sneezing
  • sore throat
  • tightness in the chest
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness in the arms, hands, legs, or feet
  • Bleeding gums
  • blood in the urine or stools
  • pinpoint red spots on the skin

Some side effects of crizotinib 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
  • Abdominal or stomach discomfort, pain, or tenderness
  • acid or sour stomach
  • back pain
  • belching
  • change in taste
  • decrease or change in vision
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • difficulty with swallowing
  • heartburn
  • increased sensitivity of the eyes to sunlight
  • indigestion
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pain or burning in the throat
  • pain or discomfort in the chest, upper stomach, or throat
  • problems with balance
  • rash
  • redness, swelling, or soreness of the tongue
  • scaling, redness, burning, pain, chapping, swelling, or other signs of inflammation of the lips
  • seeing flashes or sparks of light
  • swelling or inflammation of the mouth
  • trouble sleeping

For Healthcare Professionals

Applies to crizotinib: oral capsule


Common (1% to 10%): Electrocardiogram QT prolonged, bradycardia[Ref]


Very common (10% or more): ALT elevation (up to 76%), AST elevation (up to 61%)
Common (1% to 10%): Increased alkaline phosphatase, hepatic failure[Ref]


Very common (10% or more): Lymphopenia (up to 51%), neutropenia (up to 49%), anemia (up to 17%)
Common (1% to 10%): Leukopenia[Ref]


Very common (10% or more): Upper respiratory infection (up to 26%)
Common (1% to 10%): Pulmonary embolism, interstitial lung disease[Ref]


Very common (10% or more): Diarrhea (up to 60%), nausea (up to 55%), vomiting (up to 47%), constipation (up to 42%)
Common (1% to 10%): Dyspepsia, gastrointestinal perforation[Ref]


Very common (10% or more): Vision disorders (up to 60%)[Ref]

Vision disorders included diplopia, photophobia, photopsia, blurred vision, reduced vision acuity, visual impairment, and vitreous floaters.[Ref]


Common (1% to 10%): Rash[Ref]


The most common adverse reactions (25% or more) are vision disorder, nausea, diarrhea, vomiting, constipation, edema, elevated transaminases, and fatigue.[Ref]


Very common (10% or more): Hypophosphatemia (up to 28%), decreased appetite (up to 27%), hypokalemia (up to 18%), decreased weight (up to 10%)[Ref]

Nervous system

Neuropathy included dysesthesia, gait disturbance, hypoesthesia, muscular weakness, neuralgia, peripheral neuropathy, paresthesia, peripheral sensory neuropathy, polyneuropathy, and skin burning sensation.[Ref]

Very common (10% or more): Dysgeusia (up to 26%), dizziness (up to 22%), neuropathy (up to 19%)
Common (1% to 10%): Syncope[Ref]


Edema included face edema, generalized edema, local swelling, localized edema, peripheral edema, and periorbital edema.[Ref]

Very common (10% or more): Edema (up to 39%), fatigue (up to 27%)[Ref]


Common (1% to 10%): Renal cyst[Ref]


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

2. "Product Information. Xalkori (crizotinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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

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. 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.