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Inlyta Side Effects

Generic name: axitinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 27, 2024.

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

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

Less common

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

Less common

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Inlyta (axitinib). Pfizer U.S. Pharmaceuticals Group. 2012.

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.