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Xalkori Side Effects

Generic name: crizotinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 25, 2021.

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.

Summary

Common side effects of Xalkori include: increased serum alanine aminotransferase. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to crizotinib: oral capsules

Side effects include:

Previously untreated ALK-positive metastatic NSCLC: visual disturbances (including diplopia, photopsia, photophobia, blurred vision, visual field defect, visual impairment, vitreous floaters, and reduced visual acuity), diarrhea, vomiting, edema (including localized edema and peripheral edema), constipation, abdominal pain, upper respiratory infection, headache, dysgeusia, pyrexia, extremity pain, dyspepsia, dizziness, dysphagia, lymphopenia, elevated ALT and/or AST concentrations, hypophosphatemia.

Previously treated ALK-positive metastatic NSCLC: visual disturbances (including diplopia, photopsia, photophobia, blurred vision, visual impairment, vitreous floaters, and reduced visual acuity), diarrhea, nausea, vomiting, constipation, edema (including localized edema and peripheral edema), upper respiratory infection, decreased weight, dysgeusia, dizziness, neutropenia, elevated ALT and/or AST concentrations, hypokalemia.

ROS-1-positive metastatic NSCLC: Adverse effects similar to those in patients with ALK-positive NSCLC.

For Healthcare Professionals

Applies to crizotinib: oral capsule

Ocular

Very common (10% or more): Vision disorders (e.g., diplopia, photophobia, photopsia, reduced visual acuity, blurred vision, vitreous floaters, visual impairment) (71%), ocular hypotension (19%)

Uncommon (0.1% to 1%): Severe vision loss[Ref]

Cardiovascular

Very common (10% or more): Bradycardia (19%)

Common (1% to 10%): QT interval prolongation, cardiac failure (e.g., cardiac failure, cardiac failure congestive, ejection fraction decreased, left ventricular failure, pulmonary edema), syncope[Ref]

Hepatic

Very common (10% or more): ALT elevation (79%), AST elevation (66%), increased alkaline phosphatase (19%)

Common (1% to 10%): Hepatic failure, increased gamma-glutamyl transferase[Ref]

Hematologic

Very common (10% or more): Neutropenia (22%), lymphopenia (18%), leukopenia (15%), anemia (15%)

Common (1% to 10%): Febrile neutropenia[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (e.g., nasopharyngitis, pharyngitis, rhinitis, upper respiratory tract infection) (32%)

Common (1% to 10%): Pulmonary embolism, interstitial lung disease[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (61%), nausea (57%), vomiting (46%), constipation (43%), abdominal pain (26%), dyspepsia (14%), dysphagia (10%)

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

Dermatologic

Very common (10% or more): Rash (13%)[Ref]

General

The most common adverse reactions (25% or more) are vision disorders, nausea, diarrhea, vomiting, constipation, edema, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (up to 32%), decreased appetite (27%), hypokalemia (18%), decreased weight (10%), hypernatremia (19%), hyponatremia (12%), hyperuricemia (12%)

Common (1% to 10%): Decreased blood testosterone (e.g., blood testosterone decreased, hypogonadism, secondary hypogonadism)

Uncommon (0.1% to 1%): Increased weight[Ref]

Nervous system

Very common (10% or more): Dysgeusia (26%), dizziness (e.g., balance disorder, dizziness, dizziness postural, presyncope) (26%), neuropathy (e.g., burning sensation, dysesthesia, formication, gait disturbance, hyperesthesia, hypoesthesia, hypotonia, motor dysfunction, muscle atrophy, muscular weakness, neuralgia, neuritis, neuropathy peripheral, neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, polyneuropathy, sensory disturbance, skin burning sensation) (25%)[Ref]

Other

swelling, localized edema, peripheral edema, periorbital edema (49%), fatigue (30%), pyrexia (19%)[Ref]

Renal

Common (1% to 10%): Renal cyst (e.g., renal abscess, renal cyst, renal cyst hemorrhage, renal cyst infection), acute renal injury[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (16%)

Common (1% to 10%): Muscle spasm, muscular weakness[Ref]

Frequently asked questions

References

1. "Product Information. Xalkori (crizotinib)." Pfizer U.S. Pharmaceuticals Group (2011):

Further information

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.