Lenvima Side Effects

Generic Name: lenvatinib

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

For the Consumer

Applies to lenvatinib: capsule oral, oral capsule

Side effects requiring immediate medical attention

Along with its needed effects, lenvatinib (the active ingredient contained in Lenvima) 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 lenvatinib:

More common

• Bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blurred vision or other change in vision
• chest pain or discomfort
• chills
• cloudy urine
• confusion
• constipation
• cough
• coughing up blood
• decreased frequency or amount of urine
• depressed mood
• diarrhea
• difficulty with breathing or swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry skin and hair
• extreme tiredness or weakness
• fainting
• feeling cold
• fever
• hair loss
• hoarseness or husky voice
• increase in heart rate
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• muscle stiffness
• nervousness
• nosebleeds
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• pounding in the ears
• prolonged bleeding from cuts
• rapid or irregular breathing
• rapid weight gain
• 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
• severe headache
• slow or fast heartbeat
• sore throat
• stomach pain and bloating
• swelling of the face, fingers, feet, or lower legs
• tingling of the hands or feet
• tremor
• ulceration of the skin
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• wrinkled skin

Less common

• Clay-colored stools
• difficulty with speaking
• heartburn or indigestion
• inability to move the arms, legs, or facial muscles
• pain or discomfort in the arms, jaw, back, or neck
• severe abdominal or stomach pain, cramping, or burning
• stomach pain or tenderness
• troubled breathing with exertion
• vomiting of material that looks like coffee grounds
• yellow eyes or skin

Incidence not known

• Abnormal small opening
• impaired wound healing
• loss of appetite
• severe nausea or vomiting

Side effects not requiring immediate medical attention

Some side effects of lenvatinib 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

• Belching
• change or loss of taste
• decreased weight
• dry mouth
• hair loss or thinning of the hair
• itching or skin rash
• muscle or joint pain
• swelling or inflammation of the mouth
• trouble sleeping
• voice changes

For Healthcare Professionals

Applies to lenvatinib: oral capsule

Cardiovascular

Very common (10% or more): Hypertension (73%)

Common (1% to 10%): Hypotension, QT prolongation, arterial thromboembolic event, cardiac dysfunction (cardiac failure, decreased ventricular function, pulmonary edema)^[Ref]

Renal

Very common (10% or more): Proteinuria (34%), renal impairment (14%)

Common (1% to 10%): Increased creatinine, renal failure^[Ref]

Hematologic

Very common (10% or more): Hemorrhagic events (35%)

Common (1% to 10%): Decreased platelet count^[Ref]

Hepatic

Common (1% to 10%): Hyperbilirubinemia, increased alkaline phosphatase, increased ALT, increased AST

Very rare (less than 0.01%): Hepatic failure, acute hepatitis^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (67%), nausea (47%), stomatitis (41%), vomiting (36%), abdominal pain (31%), constipation (29%), oral pain (25%), dry mouth (17%), dyspepsia (13%)

Common (1% to 10%): GI perforation/fistula, increased serum amylase, increased lipase^[Ref]

Nervous system

Very common (10% or more): Headache (38%), dysgeusia (18%), dizziness (15%)

Common (1% to 10%): Reversible posterior leukoencephalopathy syndrome^[Ref]

Endocrine

Very common (10% or more): TSH suppression impairment (up to 88%)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (54%), weight decreased (51%)

Common (1% to 10%): Dehydration, hypoalbuminemia, hypomagnesemia, hypoglycemia, hypocalcemia, hypercalcemia, hyperkalemia, hypercholesterolemia^[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia (32%), rash (21%), alopecia (12%)

Common (1% to 10%): Hyperkeratosis^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infections (11%)^[Ref]

Immunologic

Very common (10% or more): Dental and oral infections (10%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia/myalgia (62%)^[Ref]

Other

Very common (10% or more): Fatigue (67%), peripheral edema (21%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%)^[Ref]

Respiratory

Very common (10% or more): Dysphonia (31%), cough (24%), epistaxis (12%)

Common (1% to 10%): Pulmonary embolism^[Ref]

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.

Medical Disclaimer