Lenvima Side Effects

Generic Name: lenvatinib

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

For the Consumer

Applies to lenvatinib: capsule oral, oral capsule

In addition to its needed effects, some unwanted effects may be caused by lenvatinib (the active ingredient contained in Lenvima). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with lenvatinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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]

Not all side effects for Lenvima may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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