82/100 · Critical
Manufactured by Celgene Corporation
Lenalidomide Adverse Events: High Seriousness and Diverse Reactions
557,894 FDA adverse event reports analyzed
Last updated: 2026-05-12
LENALIDOMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Celgene Corporation. Based on analysis of 557,894 FDA adverse event reports, LENALIDOMIDE has a safety score of 82 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 LENALIDOMIDE include DIARRHOEA, DEATH, FATIGUE, PNEUMONIA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LENALIDOMIDE.
Lenalidomide has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 557,894 adverse event reports for this medication, which is primarily manufactured by Celgene Corporation.
The most commonly reported adverse events include Diarrhoea, Death, Fatigue. Of classified reports, 64.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Lenalidomide reports show a high percentage of serious adverse events, particularly death and pneumonia.
The drug is associated with a wide range of reactions, including hematological and neurological issues. Reports indicate significant gastrointestinal and respiratory side effects.
Patients taking Lenalidomide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lenalidomide can interact with other drugs, potentially affecting its efficacy or increasing side effects. Warnings include the risk of thrombosis and infection, especially in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lenalidomide received a safety concern score of 82/100 (high concern). This is based on a 64.2% serious event ratio across 408,476 classified reports. The score accounts for 557,894 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: Male: 202,495, Female: 190,984, Unknown: 651. The most frequently reported age groups are age 72 (9,795 reports), age 74 (9,503 reports), age 73 (9,462 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 408,476 classified reports for LENALIDOMIDE:
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.
Lenalidomide can interact with other drugs, potentially affecting its efficacy or increasing side effects. Warnings include the risk of thrombosis and infection, especially in patients with pre-existing conditions.
If you are taking Lenalidomide, here are important things to know. The most commonly reported side effects include diarrhoea, death, fatigue, pneumonia, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse events. 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.
The FDA closely monitors lenalidomide due to its high rate of serious adverse events. Healthcare providers should be vigilant in managing patient risks and monitoring for signs of severe reactions.
The FDA has received approximately 557,894 adverse event reports associated with Lenalidomide. 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 Lenalidomide include Diarrhoea, Death, Fatigue, Pneumonia, Off Label Use. By volume, the top reported reactions are: Diarrhoea (30,628 reports), Death (26,182 reports), Fatigue (26,153 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lenalidomide.
Out of 408,476 classified reports, 262,213 (64.2%) were classified as serious and 146,263 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 Lenalidomide break down by patient sex as follows: Male: 202,495, Female: 190,984, Unknown: 651. 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 Lenalidomide adverse events are: age 72: 9,795 reports, age 74: 9,503 reports, age 73: 9,462 reports, age 75: 9,371 reports, age 71: 9,280 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 Lenalidomide adverse event reports is Celgene Corporation. 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 Lenalidomide include: Rash, Plasma Cell Myeloma, Neuropathy Peripheral, White Blood Cell Count Decreased, Constipation. 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 Lenalidomide 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.
Lenalidomide has a safety concern score of 82 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. Lenalidomide reports show a high percentage of serious adverse events, particularly death and pneumonia.
Key safety signals identified in Lenalidomide's adverse event data include: Death and pneumonia are among the most serious reactions reported.. Hematological issues such as decreased white blood cell count and thrombocytopenia are common.. Neurological symptoms like peripheral neuropathy and dizziness are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lenalidomide can interact with other drugs, potentially affecting its efficacy or increasing side effects. Warnings include the risk of thrombosis and infection, especially in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lenalidomide.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse events.
Lenalidomide has 557,894 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including hematological and neurological issues. The volume of reports for Lenalidomide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors lenalidomide due to its high rate of serious adverse events. Healthcare providers should be vigilant in managing patient risks and monitoring for signs of severe reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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