Primary Adverse Drug Reactions

The following are considered to be Adverse Drug Reactions (ADRs) for lenvatinib:

Blood and Lymphatic System Disorders: Lymphopenia, Thrombocytopenia, Leukopenia, Neutropenia

Cardiac Disorders: Cardiac failure, QT interval prolongation

Endocrine Disorders: Hypothyroidism

Gastrointestinal Disorders: Abdominal pain, Amylase increased*, Constipation, Diarrhea, Dry mouth, Dyspepsia, Flatulence, Gastrointestinal perforation and fistula, Lipase increased*, Nausea, Oral pain, Pancreatitis*, Stomatitis, Vomiting

 General Disorders and Administration Site Conditions: Asthenia, Edema peripheral, Fatigue, Malaise, Impaired Wound Healing*

Hepatobiliary Disorders: Cholecystitis*, Hepatotoxicity, Hepatic failure‡, Hepatic encephalopathy‡.

Infections and Infestations: Urinary tract infection

Investigations: Weight decreased

 Metabolism and Nutrition Disorders: Decreased appetite, Dehydration, Hypercholesterolemia, Hypocalcemia, Hypokalemia, Hypomagnesemia

 Musculoskeletal and Connective Tissue Disorders: Arthralgia, Back pain, Musculoskeletal pain, Myalgia, Pain in extremity, Osteonecrosis of the jaw*

Nervous System Disorders: Dizziness, Dysgeusia, Headache, Reversible posterior leukoencephalopathy syndrome

Psychiatric Disorders: Insomnia

 Renal and Urinary Disorders: Nephrotic syndrome*, Proteinuria, Renal failure‡, Renal impairment, Respiratory, Thoracic and Mediastinal Disorders: Cough, Dysphonia, Pneumothorax*‡, Pulmonary embolism‡

Skin and Subcutaneous Tissue Disorders: Alopecia, Hyperkeratosis, Palmar-plantar erythrodysesthesia syndrome, Rash

Vascular Disorders: Arterial thromboembolic events‡, Hemorrhage‡, Hypertension, Hypotension, Aortic Dissection‡*.

Includes fatal events

* Identified from post-marketing use of lenvatinib


Reporting of suspected adverse drug reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph