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 |
