Applies to lenvatinib: oral capsules.

Side effects include:

Adverse effects reported in ≥30% of patients receiving lenvatinib for the treatment of differentiated thyroid cancer include hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite and weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

Adverse effects reported in ≥20% of patients receiving lenvatinib in combination with pembrolizumab for the treatment of renal cell carcinoma include fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, hepatotoxicity, headache, and acute kidney injury.

Adverse effects reported in ≥30% of patients receiving lenvatinib in combination with everolimus for the treatment of renal cell carcinoma include diarrhea, fatigue, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, decreased weight, hemorrhagic events, and proteinuria.

Adverse effects reported in ≥20% of patients receiving lenvatinib for the treatment of hepatocellular carcinoma include hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite and weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

Adverse effects reported in ≥20% of patients receiving lenvatinib for the treatment of endometrial carcinoma include hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite and weight, vomiting, stomatitis, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia syndrome, dysphonia, and rash.

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), myocardial infarction, cerebrovascular accident^[Ref]

Renal

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

Common (1% to 10%): Increased creatinine, renal failure

Postmarketing reports: Nephrotic syndrome^[Ref]

Hematologic

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

Common (1% to 10%): Decreased platelet count

Postmarketing reports: Arterial (including aortic) aneurysms, dissections, and rupture, impaired wound healing^[Ref]

Hepatic

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

Very rare (less than 0.01%): Hepatic failure, acute hepatitis

Postmarketing reports: Cholecystitis^[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

Postmarketing reports: Pancreatitis, increased amylase^[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%)

Uncommon (0.1% to 1%): Osteonecrosis of the jaw^[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]