85/100 · Critical
Manufactured by Eisai Inc.
High Serious Adverse Event Rate for Lenvatinib
64,104 FDA adverse event reports analyzed
Last updated: 2026-05-12
LENVATINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eisai Inc.. Based on analysis of 64,104 FDA adverse event reports, LENVATINIB has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LENVATINIB include DIARRHOEA, HYPERTENSION, FATIGUE, DECREASED APPETITE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LENVATINIB.
Lenvatinib has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 64,104 adverse event reports for this medication, which is primarily manufactured by Eisai Inc..
The most commonly reported adverse events include Diarrhoea, Hypertension, Fatigue. Of classified reports, 87.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Diarrhoea, hypertension, and fatigue are the most common adverse events.
Serious adverse events, including death and interstitial lung disease, are frequent. A wide range of reactions, including hepatic and renal impairment, are reported.
Patients taking Lenvatinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lenvatinib can cause severe adverse reactions such as interstitial lung disease and hepatic impairment, and caution is advised when co-administered with other drugs that may affect these systems. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lenvatinib received a safety concern score of 85/100 (high concern). This is based on a 87.9% serious event ratio across 30,632 classified reports. The score accounts for 64,104 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 14,758, Male: 14,498, Unknown: 14. The most frequently reported age groups are age 69 (862 reports), age 70 (853 reports), age 68 (829 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,632 classified reports for LENVATINIB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Lenvatinib can cause severe adverse reactions such as interstitial lung disease and hepatic impairment, and caution is advised when co-administered with other drugs that may affect these systems.
If you are taking Lenvatinib, here are important things to know. The most commonly reported side effects include diarrhoea, hypertension, fatigue, decreased appetite, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious adverse events such as interstitial lung disease and hepatic impairment. Follow healthcare provider's instructions closely and report any new or worsening symptoms. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with Lenvatinib requiring close monitoring for serious adverse events and regular health check-ups.
The FDA has received approximately 64,104 adverse event reports associated with Lenvatinib. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Lenvatinib include Diarrhoea, Hypertension, Fatigue, Decreased Appetite, Nausea. By volume, the top reported reactions are: Diarrhoea (3,869 reports), Hypertension (3,419 reports), Fatigue (3,124 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lenvatinib.
Out of 30,632 classified reports, 26,917 (87.9%) were classified as serious and 3,715 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Lenvatinib break down by patient sex as follows: Female: 14,758, Male: 14,498, Unknown: 14. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Lenvatinib adverse events are: age 69: 862 reports, age 70: 853 reports, age 68: 829 reports, age 65: 817 reports, age 71: 802 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Lenvatinib adverse event reports is Eisai Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Lenvatinib include: Malignant Neoplasm Progression, Blood Pressure Increased, Vomiting, Asthenia, Dehydration. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Lenvatinib to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Lenvatinib has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Diarrhoea, hypertension, and fatigue are the most common adverse events.
Key safety signals identified in Lenvatinib's adverse event data include: High incidence of serious adverse events (87.9%). Multiple organ systems affected, including liver, kidneys, and lungs. Significant risk of gastrointestinal and cardiovascular issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lenvatinib can cause severe adverse reactions such as interstitial lung disease and hepatic impairment, and caution is advised when co-administered with other drugs that may affect these systems. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lenvatinib.
Monitor for signs of serious adverse events such as interstitial lung disease and hepatic impairment. Follow healthcare provider's instructions closely and report any new or worsening symptoms.
Lenvatinib has 64,104 adverse event reports on file with the FDA. Serious adverse events, including death and interstitial lung disease, are frequent. The volume of reports for Lenvatinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with Lenvatinib requiring close monitoring for serious adverse events and regular health check-ups. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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