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

Summary

Common side effects of Inlyta include: headache, hypertension, hypothyroidism, increased serum alanine aminotransferase, and proteinuria. Continue reading for a comprehensive list of adverse effects.

Applies to axitinib: oral tablet.

Serious side effects of Inlyta

Along with its needed effects, axitinib (the active ingredient contained in Inlyta) 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 axitinib:

More common

• Bleeding gums
• bloody nose
• blurred vision
• chest tightness
• clay colored stools
• cloudy urine
• confusion
• constipation
• coughing up blood
• decreased urination
• depressed mood
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• dry mouth
• dry skin and hair
• fainting
• feeling cold
• fever
• hair loss
• headache
• hoarseness or husky voice
• incoherent speech
• increased menstrual flow or vaginal bleeding
• increased urination
• itching skin or rash
• lightheadedness
• loss of appetite
• metallic taste
• muscle cramps, stiffness, or weakness
• nausea
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• rapid breathing
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• slow or fast heartbeat
• stomach pain or tenderness
• sunken eyes
• swelling of the feet or lower legs
• thirst
• tingling of the hands and feet
• ulceration of the skin
• unusual tiredness or weakness
• vomiting
• weight gain or loss
• wrinkled skin
• yellow eyes or skin

Less common

• Anxiety
• bleeding from the gums or nose
• bleeding from the rectum
• bloody, black or tarry stools
• change in vision
• chest pain or discomfort
• extreme drowsiness
• eye pain
• heartburn
• inability to speak
• indigestion
• numbness or tingling in the face, arms, hands, or legs
• pain in the chest, groin, or legs
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• pale skin
• ringing in the ears
• seizures
• sensitivity to heat
• severe headaches of sudden onset
• severe stomach pain, cramping, or burning
• slurred speech
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• temporary blindness
• trouble sleeping
• trouble speaking, thinking, or walking
• trouble breathing
• uncomfortable swelling around the anus
• unusual bleeding or bruising
• vomiting of material that looks like coffee grounds
• weakness in the arm or leg on one side of the body

Other side effects of Inlyta

Some side effects of axitinib 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

• Belching
• change in taste
• cough
• cracked lips
• decreased appetite
• diarrhea
• difficulty with moving
• joint pain or swelling
• lack or loss of strength
• loss of taste
• muscle aches or pain
• pain in the arms or legs
• sore throat
• stomach discomfort or upset
• swelling or inflammation of the mouth
• upper stomach pain
• voice changes

Less common

• Burning sensation of the tongue
• continuous ringing or buzzing or other unexplained noise in the ears
• flushing or redness of the skin
• hearing loss
• thinning of the hair
• unusually warm skin

For Healthcare Professionals

Applies to axitinib: oral tablet.

General

The most common adverse reactions included diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome, decreased weight, vomiting, asthenia, and constipation.^[Ref]

Cardiovascular

Hypertension has been reported in up to 40% or patients, with grade 3 or 4 hypertension and hypertensive crisis in 16% and less than 1% of those patients, respectively. The median onset time for hypertension was within the first month, with increases observed as early as 4 days after starting the drug. Less than 1% of patients discontinued therapy due to hypertension.

Arterial thromboembolic events including transient ischemic attacks, cerebrovascular accidents, myocardial infarctions, and retinal artery occlusions were reported in 2% of patients (17 of 715) and venous thromboembolic events including pulmonary embolism, deep vein thrombosis, retinal vein occlusion, and retinal vein thrombosis were reported in 3% of patients (22 of 715).

Cardiac failure was reported in 2% (6 of 359) patients; grade 3 or 4 in 1% (2 of 359).^[Ref]

Very common (10% or more): Hypertension (40%)

Common (1% to 10%): Deep vein thrombosis, cardiac failure events, venous thromboembolic events, arterial thromboembolic events, myocardial infarction

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

Nervous system

Very common (10% or more): Headache (15%), dysgeusia (11%)

Common (1% to 10%): Dizziness, transient ischemic attack

Rare (less than 0.1%): Posterior reversible encephalopathy syndrome

Frequency not reported: Cerebrovascular accidents^[Ref]

Arterial thromboembolic events including transient ischemic attacks, cerebrovascular accidents, myocardial infarctions, and retinal artery occlusions were reported in 2% of patients (17 of 715).

Three cases of reversible posterior leukoencephalopathy syndrome (RPLS), also known as posterior reversible encephalopathy syndrome (PRES) were reported during clinical trials.^[Ref]

Ocular

Arterial thromboembolic events including transient ischemic attacks, cerebrovascular accidents, myocardial infarctions, and retinal artery occlusions were reported in 2% of patients (17 of 715). Venous thromboembolic events including pulmonary embolism, deep vein thrombosis, retinal vein occlusion, and retinal vein thrombosis were reported in 3% of patients (22 of 715).^[Ref]

Common (1% to 10%): Retinal vein occlusion/thrombosis

Frequency not reported: Retinal artery occlusions^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (55%), nausea (32%), vomiting (24%), constipation (20%), stomatitis (15%), abdominal pain (14%), increased lipase (27%), increased amylase (25%)

Common (1% to 10%): Upper abdominal pain, hemorrhoids, glossodynia, rectal hemorrhage, dyspepsia, flatulence

Uncommon (0.1% to 1%): Gastrointestinal perforation, fistulas

Frequency not reported: Lower gastrointestinal hemorrhage, melena^[Ref]

Hepatic

Very common (10% or more): Transaminase increases (20% to 22%), alkaline phosphatase increases (30%), hypoalbuminemia (15%)^[Ref]

Renal

Very common (10% or more): Increased creatinine (55%), proteinuria (11%)

Common (1% to 10%): Hematuria, renal failure^[Ref]

Other

Very common (10% or more): Fatigue (39%), asthenia (21%),

Common (1% to 10%): Tinnitus^[Ref]

Dermatologic

Very common (10% or more): Hand-foot syndrome (27%), rash (13%)

Common (1% to 10%): Pruritus, alopecia, erythema, dry skin^[Ref]

Endocrine

Hypothyroidism was reported in 20.9% of patients and hyperthyroidism in 1.1%. Among patients with TSH levels less than 5 micromoles/mL prior to treatment, elevations to greater 10 micromoles/mL occurred in greater than 32.2%^[Ref]

Very common (10% or more): Hypothyroidism (20%),

Common (1% to 10%): Hyperthyroidism, increased thyroid stimulating hormone (TSH)^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (35%), decreased lymphocytes (33%) decreased platelets (15%), WBC decreased (11%)

Common (1% to 10%): Anemia, polycythemia, increased hemoglobin

Uncommon (0.1% to 1%): Neutropenia, leukopenia^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (34%), weight loss (25%), decreased bicarbonate (44%), hypocalcemia (39%), hyperglycemia (28%), hypernatremia (17%), hyperkalemia (15%), hypoglycemia (11%), hyponatremia (13%), hypophosphatemia (13%)

Common (1% to 10%): Dehydration^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (15%), extremity pain (14%),

Common (1% to 10%): Myalgia,^[Ref]

Respiratory

Very common (10% or more): Dysphonia (31%), cough (15%), mucosal inflammation (15%), dyspnea (15%)

Common (1% to 10%): Epistaxis, pulmonary embolism, hemoptysis^[Ref]

Venous thromboembolic events including pulmonary embolism, deep vein thrombosis, retinal vein occlusion, and retinal vein thrombosis were reported in 3% of patients (22 of 715).^[Ref]