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.

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.

For the Consumer

Applies to crizotinib: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking crizotinib (the active ingredient contained in Xalkori) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using crizotinib and call your doctor at once if you have a serious side effect such as:

• severe dizziness, fainting, fast or pounding heartbeats;

• vision problems such as blurred vision, increased sensitivity of your eyes to light, or seeing flashes of light or "floaters";

• chest pain, dry cough or cough with mucus, wheezing, feeling short of breath;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of crizotinib may include:

• mild dizziness;

• tired feeling;

• nausea, vomiting, stomach pain, loss of appetite;

• diarrhea, constipation;

• mild rash or itching;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• numbness or tingling; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to crizotinib: oral capsule

Dermatologic

Dermatologic side effects have included rash (10%).

Gastrointestinal

Gastrointestinal side effects have included nausea (53%), diarrhea (43%), vomiting (40%), constipation (27%), esophageal disorder (11%), abdominal pain (8%), and stomatitis (6%).

General

General side effects have included edema (28%), fatigue (20%), chest pain/discomfort (1%), and fever (less than 1%).

Hepatic

Hepatic side effects have included alanine aminotransferase (ALT) increased (13%), and aspartate aminotransferase (AST) increased (9%).

Metabolic

Metabolic side effects have included decreased appetite (19%).

Laboratory abnormalities have included Grade 3 or 4 lymphopenia (11.4%), Grade 3 or 4 neutropenia (5.2%), and Grade 3 or 4 thrombocytopenia (0.4%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (2%), and back pain (less than 1%).

Nervous system

Nervous system side effects have included dizziness (16%), neuropathy (13%), dysgeusia (12%), and headache (4%).

Ocular

Ocular side effects have included vision disorder (62%).

Psychiatric

Psychiatric side effects have included insomnia (3%).

Respiratory

Respiratory side effects have included cough (4%), dyspnea (2%), and upper respiratory infection (2%).

Genitourinary

Genitourinary side effects have included hypogonadism.

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