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Tivozanib Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 12, 2024.

Applies to tivozanib: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits for any unwanted effects from the medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use an effective form of birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 1 month after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, irregular or trouble breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, unusual tiredness or weakness, or weight gain. These may be symptoms of a serious heart problem (eg, heart failure).

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, difficulty with breathing, loss of sensation, confusion, or problems with muscle control or speech.

This medicine may increase your risk of bleeding. Tell your doctor right away if you cough up blood or have bleeding gums, difficulty with breathing or swallowing, dizziness, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This may increase the levels of protein in your urine, which may lead to kidney damage. Tell your doctor right away if you have cloudy urine.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine at least 24 days before having a surgery. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.

This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Check with your doctor right away if you have headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of tivozanib

Along with its needed effects, tivozanib 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 tivozanib:

More common side effects

  • agitation
  • back pain
  • black, tarry stools
  • bleeding from the rectum or bloody stools
  • bleeding gums
  • blood in the urine
  • bloody nose
  • blurred vision
  • change in consciousness
  • cloudy urine
  • collection of blood under the skin
  • confusion
  • confusion as to time, place, or person
  • constipation
  • coughing or spitting up blood
  • decreased urine output
  • deep, dark purple bruise
  • depressed mood
  • depression
  • difficulty in swallowing
  • dilated neck veins
  • dizziness
  • drowsiness
  • dry skin and hair
  • enlarged pupils
  • feeling cold
  • fever
  • hair loss
  • heavy nonmenstrual vaginal bleeding
  • hoarseness or husky voice
  • holding false beliefs that cannot be changed by fact
  • hostility
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the eyes to light
  • increased sweating, possibly with fever or cold, clammy skin
  • irregular breathing
  • irregular heartbeat
  • irritability
  • itching
  • lethargy
  • loss of consciousness
  • muscle cramps, stiffness, twitching
  • nausea
  • nervousness
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, or swelling in the arm or leg
  • pains in the chest, groin, or legs, especially calves of the legs
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or dark brown urine
  • red or black, tarry stools
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sensitivity to heat
  • severe chest pain
  • severe headache
  • slow or fast heartbeat
  • sore throat
  • stiff or sore neck
  • stupor
  • sudden loss of coordination
  • sudden onset of slurred speech
  • sudden onset of trouble breathing for no apparent reason
  • sudden vision changes
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • trouble breathing
  • trouble healing
  • trouble sleeping
  • unusual excitement, nervousness, or restlessness
  • unusual tiredness or weakness
  • voice changes
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • weight gain or loss

Other side effects of tivozanib

Some side effects of tivozanib 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 side effects

  • blistering, crusting, irritation, itching, or reddening of the skin
  • blistering, peeling, loosening of the skin
  • cracked, dry, scaly skin
  • cough
  • decreased appetite
  • diarrhea
  • dry, flaky, scaling skin on the scalp, eyebrows, near the ears, and around the nose
  • increased sensitivity of skin to sunlight
  • joint or muscle pain
  • lack or loss of strength
  • rash with flat lesions or small raised lesions on the skins
  • red, irritated eyes
  • redness or other discoloration of skin
  • severe sunburn
  • skin rash, encrusted, scaly and oozing
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling
  • swelling or inflammation of the mouth

For healthcare professionals

Applies to tivozanib: oral capsule.

General adverse events

Serious adverse reactions occurred in 45% of patients who received this drug. Serious adverse reactions in greater than 2% of patients included bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%). Fatal adverse reactions occurred in 8% of patients, including pneumonia (1.7%), hepatobiliary disorders (1.2%), respiratory failure (1.2%), myocardial infarction (0.6%), cerebrovascular accident (0.6%), and subdural hematoma (0.6%)[Ref]

Musculoskeletal

Metabolic

Hepatic

Respiratory

Other

Hematologic

Renal

Cardiovascular

Dermatologic

Endocrine

Gastrointestinal

See also:

References

1. (2021) "Product Information. Fotivda (tivozanib)." Aveo Pharmaceuticals, Inc.

Further information

Tivozanib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.