What the label lists and what reports show
Lenvatinib side effects
Lenvatinib's FDA label: “In DTC, the most common adverse reactions (incidence ≥30%) for LENVIMA are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia …” FAERS holds 32,614 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (4,133 reports).
- No generic listed
Check it at the source: the lenvatinib FDA label on DailyMed (effective June 30, 2026, Eisai Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LENVIMA?LENVIMA may cause serious side effects, including: H igh blood pressure (hypertension). High blood pressure is a common side effect of LENVIMA and can be serious. Your blood pressure should be well controlled before you start taking LENVIMA. Your healthcare provider should check your blood pressure regularly during treatment with LENVIMA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure. H eart problems. LENVIMA can cause serious heart problems that may lead to death. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles. P roblem with blood clots in your blood vessels (arteries). […]
Source: FDA drug label, Eisai Inc., effective June 30, 2026 (SPL set f4bedd21-efde-44c6-9d9c-b48b78d7ed1e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn DTC, the most common adverse reactions (incidence ≥30%) for LENVIMA are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.
Table 3 : Adverse Reactions Occurring in Patients with a Between-Group Difference of ≥5%…
| Reaction | All Grades (%) | Grades 3-4 (%) | All Grades (%) | Grades 3- 4 (%) |
|---|---|---|---|---|
| Hypertension a | 73 | 44 | 16 | 4 |
| Hypotension | 9 | 2 | 2 | 0 |
| Diarrhea | 67 | 9 | 17 | 0 |
| Nausea | 47 | 2 | 25 | 1 |
| Stomatitis b | 41 | 5 | 8 | 0 |
| Vomiting | 36 | 2 | 15 | 0 |
| Abdominal pain c | 31 | 2 | 11 | 1 |
| Constipation | 29 | 0.4 | 15 | 1 |
| Oral pain d | 25 | 1 | 2 | 0 |
| Dry mouth | 17 | 0.4 | 8 | 0 |
| Dyspepsia | 13 | 0.4 | 4 | 0 |
| Fatigue e | 67 | 11 | 35 | 4 |
| Edema peripheral | 21 | 0.4 | 8 | 0 |
| Arthralgia/Myalgia f | 62 | 5 | 28 | 3 |
| Decreased appetite | 54 | 7 | 18 | 1 |
| Decreased weight | 51 | 13 | 15 | 1 |
| Dehydration | 9 | 2 | 2 | 1 |
| Headache | 38 | 3 | 11 | 1 |
| Dysgeusia | 18 | 0 | 3 | 0 |
| Dizziness | 15 | 0.4 | 9 | 0 |
| Proteinuria | 34 | 11 | 3 | 0 |
| Palmar-plantar erythrodysesthesia | 32 | 3 | 1 | 0 |
| Rash g | 21 | 0.4 | 3 | 0 |
| Alopecia | 12 | 0 | 5 | 0 |
| Hyperkeratosis | 7 | 0 | 2 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere in the labeling: Hypertension [see Warnings and Precautions ( 5.1 )] Cardiac Dysfunction [see Warnings and Precautions ( 5.2 )] Arterial Thromboembolic Events [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Renal Failure and Impairment [see Warnings and Precautions ( 5.5 )] Proteinuria [see Warnings and Precautions ( 5.6 )] Diarrhea [see Warnings and Precautions ( 5.7 )] Fistula Formation and Gastrointestinal Perforation [see Warnings and Precautions ( 5.8 )] QT Interval Prolongation [see Warnings and Precautions ( 5.9 )] Hypocalcemia [see Warnings and Precautions ( 5.10 )] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.11 )] Hemorrhagic Events [see Warnings and Precautions ( 5.12 )] Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction [see Warnings and Precautions ( 5.13 )] Impaired Wound Healing [see Warnings and Precautions ( 5.14 )] Osteonecrosis of the Jaw (ONJ) [see Warnings and Precautions ( 5.15 )] In DTC, the most common adverse reactions (incidence ≥30%) for LENVIMA are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.
Source: FDA drug label, Eisai Inc., effective June 30, 2026 (SPL set f4bedd21-efde-44c6-9d9c-b48b78d7ed1e), via openFDA; the full label on DailyMed
What do FAERS reports show?
32,614 reports list lenvatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,443 are coded as a death and 19,735 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 21 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lenvatinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions