Pill Identifier App

Axitinib Side Effects

Not all side effects for axitinib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to axitinib: oral tablet

In addition to its needed effects, some unwanted effects may be caused by axitinib. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking axitinib:

More common
  • Abdominal or stomach pain
  • bleeding gums
  • bloody nose
  • blurred vision
  • 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
  • hair loss
  • hoarseness or husky voice
  • incoherent speech
  • increased menstrual flow or vaginal bleeding
  • increased urination
  • lightheadedness
  • loss of appetite
  • metallic taste
  • muscle cramps and stiffness
  • muscle 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
  • sunken eyes
  • thirst
  • tightness in the chest
  • tingling of the hands and feet
  • ulceration of the skin
  • unusual tiredness or weakness
  • vomiting
  • weight gain or loss
  • wrinkled 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
  • sudden loss of coordination
  • sudden onset of slurred speech
  • sudden shortness of breath or troubled breathing
  • sudden vision changes
  • sweating
  • temporary blindness
  • trouble sleeping
  • trouble speaking, thinking, or walking
  • troubled breathing with exertion
  • 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

Some of the side effects that can occur with axitinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Belching
  • change in taste
  • cough
  • cracked lips
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • itching skin
  • joint pain
  • lack or loss of strength
  • loss of taste
  • muscle aches or pain
  • pain in the arms or legs
  • rash
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach discomfort or upset
  • swelling or inflammation of the mouth
  • swollen joints
  • 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

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]

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]

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Inlyta (axitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)