This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Lenalidomide is a medication, a thalidomide analog. According to the FDA-approved label, Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). FAERS contains 414,398 submissions naming this drug from 2003 through 2026; the top three reactions cited are diarrhoea, death, and fatigue.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Lenalidomide. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Lenalidomide. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 414,398 FAERS submissions that named Lenalidomide. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Lenalidomide. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Lenalidomide. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Limitations of Use: Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ). 1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). (continues in label)
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other sections of the prescribing information: Embryo-Fetal Toxicity [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.2 )] Hematologic Toxicity [see Boxed Warning , Warnings and Precautions ( 5.3 )] Venous and Arterial Thromboembolism [see Boxed Warning , Warnings and Precautions ( 5.4 )] Increased Mortality in Patients with CLL [see Warnings and Precautions ( 5.5 )] Second Primary Malignancies [see Warnings and Precautions ( 5.6 )] Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.9 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.10 )] Tumor Flare Reactions [see Warnings and Precautions ( 5.11 )] Impaired Stem Cell Mobilization [see Warnings and Precautions ( 5.12 )] Thyroid Disorders [see Warnings and Precautions ( 5.13 )] Early Mortality in Patients with MCL [see Warnings and Precautions ( 5.14 )] Hypersensitivity [see Warnings and Precautions ( 5. (continues in label)
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
