Fotivda Side Effects

Generic name: tivozanib

Medically reviewed by Drugs.com. Last updated on Jul 23, 2023.

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]