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

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:

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• changes in vision
• chest pain or discomfort
• confusion
• coughing up blood
• decreased frequency or amount of urine
• difficulty with breathing or swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• extreme fatigue
• fainting
• 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
• nervousness
• nosebleeds
• numbness and tingling around the mouth, fingertips, or feet
• paralysis
• rapid or irregular breathing
• rapid weight gain
• red or black, tarry stools
• red or dark brown urine
• redness, swelling, or pain of the skin
• severe headache
• slow or fast heartbeat
• swelling of the face, fingers, feet, or lower legs
• tingling of the hands or feet
• tremor
• ulceration of the skin
• unusual tiredness or weakness
• unusual bleeding or bruising
• vomiting
• wrinkled skin

• Abdominal or stomach pain or tenderness
• clay colored stools
• dark urine
• difficulty with speaking
• fever
• 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
• vomiting of material that looks like coffee grounds
• yellow eyes or skin

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:

• Belching
• change or loss of taste
• decreased appetite
• dry mouth
• hair loss or thinning of the hair
• headache
• hoarseness
• itching or skin rash
• muscle pain or stiffness
• nausea
• pain in the joints
• sore throat
• 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

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%)

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%)

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