Axitinib Side Effects

Some side effects of axitinib 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 axitinib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking axitinib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• sudden numbness or weakness, problems with speech or balance;

• pain, swelling, warmth, or redness in one or both legs;

• severe headache, confusion, change in mental status, vision loss, and/or seizure (convulsions);

• severe stomach pain;

• red or pink urine, bloody or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

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

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;

• any wound that will not heal;

• sudden weight loss, increased appetite, pounding heartbeats, fluttering in your chest, feeling very weak or tired, muscle pain, numbness or tingling in your hands, dry skin and hair, feeling hot or cold, changes in your menstrual periods, hoarse voice, swelling in your neck or throat (enlarged thyroid); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats).

Less serious side effects of axitinib may include:

• nausea, vomiting;

• diarrhea, constipation; or

• loss of appetite.

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 axitinib: oral tablet

Cardiovascular

Cardiovascular side effects have included hypertension (40%), deep vein thrombosis (1%), and retinal vein occlusion/thrombosis (1%).

Dermatologic

Dermatologic side effects have included palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome) (27%), rash (13%), dry skin (10%), pruritus (7%), alopecia (4%), and erythema (2%).

Endocrine

Endocrine side effects have included hypothyroidism (19%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (55%), decreased appetite (34%), nausea (32%), vomiting (24%), constipation (20%), stomatitis (15%), mucosal inflammation (15%), abdominal pain (14%), dysgeusia (11%) and dyspepsia (10%), upper abdominal pain (8%), hemorrhoids (4%), and rectal hemorrhage (2%).

General

General side effects have included fatigue (39%), decreased appetite (34%), weight decreased (25%), asthenia (21%), and dehydration (6%)

Genitourinary

Genitourinary side effects have included proteinuria (11%), and hematuria (3%).

Hematologic

Hematologic side effects have included epistaxis (6%), anemia (4%), and polycythemia (1%).

Metabolic

Laboratory abnormalities have included increased creatinine (55%), decreased bicarbonate (44%), hypocalcemia (39%), decreased hemoglobin (35%), decreased lymphocytes (33%), increased alkaline phosphatase (30%), hyperglycemia (28%), increased lipase (27%), increased amylase (25%), increased alanine transaminase (ALT) (22%), increased aspartate aminotransferase (AST) (20%), hypernatremia (17%), hypoalbuminemia (15%), hyperkalemia (15%), decreased platelets (15%), hyponatremia (13%), hypophosphatemia (13%), hypoglycemia (11%), and decreased white blood cells (11%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (15%), pain in extremity (13%), and myalgia (7%).

Nervous system

Nervous system side effects have included headache (14%), dizziness (9%), tinnitus (3%), transient ischemic attack (1%), and reversible posterior leukoencephalopathy syndrome (RPLS) (less than 1%).

Ocular

Ocular side effects have included retinal vein occlusion/thrombosis (1%).

Other

Other side effects have included dysphonia (31%).

Respiratory

Respiratory side effects have included cough (15%), dyspnea (15%), and hemoptysis (2%).

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