Note: This document contains side effect information about tivozanib. Some dosage forms listed on this page may not apply to the brand name Fotivda.
Applies to tivozanib: oral capsule.
Serious side effects of Fotivda
Along with its needed effects, tivozanib (the active ingredient contained in Fotivda) 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
- 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 Fotivda
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
- 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.
Hematologic
Very common (10% or more): Activated partial thromboplastin time prolonged (26%), lymphocytes decreased (25%), hemoglobin increased (19%), platelets decreased (19%), bleeding (e.g., hematuria, epistaxis, hemoptysis, hematoma, rectal hemorrhage, vaginal hemorrhage, contusion, GI hemorrhage, hematochezia, intraocular hematoma, melena, metrorrhagia, pulmonary hemorrhage, subdural hematoma, gingival bleeding, hematemesis, hemorrhage intracranial, hemorrhoidal hemorrhage, splinter hemorrhages (17%), hemoglobin decreased (16%)[Ref]
Musculoskeletal
Very common (10% or more): Back pain (19%)[Ref]
Metabolic
Very common (10% or more): Glucose increased (50%), phosphate decreased (38%), anorexia (39%), sodium decreased (36%), potassium increased (26%), magnesium decreased (26%), weight loss (17%), calcium increased (15%)[Ref]
Hepatic
Very common (10% or more): ALT increased (30%), alkaline phosphatase increased (30%), AST increased (30%), bilirubin increased (11%)[Ref]
Respiratory
Very common (10% or more): Dysphonia (27%), cough (22%), dyspnea (15%)[Ref]
Other
Very common (10% or more): Fatigue/asthenia (67%)[Ref]
General
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]
Renal
Very common (10% or more): Creatinine increased (50%)[Ref]
Cardiovascular
Very common (10% or more): Hypertension/blood pressure increased/hypertensive crisis (44%)[Ref]
Dermatologic
Very common (10% or more): Rash (e.g., dermatitis, dermatitis acneiform, dermatitis contact, drug eruption, eczema, eczema nummular, erythema, erythema multiforme, photosensitivity reaction, pruritus, psoriasis, rash erythematous, rash generalized, rash macular, rash maculopapular, rash morbilliform, rash pruritic, seborrheic dermatitis, skin exfoliation, skin irritation, skin lesion, swelling face, toxic skin eruption, urticaria) (18%), Palmar-plantar erythrodysesthesia syndrome[Ref]
Endocrine
Very common (10% or more): Hypothyroidism (including blood thyroid stimulating hormone increased, triiodothyronine decreased, triiodothyronine free decreased (44%)[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (43%), lipase increased (32%), nausea (30%), amylase increased (23%), stomatitis (21%), vomiting (18%)[Ref]
