Prescription medicine
Lenalidomide Brand names: Revlimid
Lenalidomide (Revlimid) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 18 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the lenalidomide FDA label on DailyMed (effective March 24, 2023, Celgene Corporation); the NDA 21880 record on Drugs@FDA; every lenalidomide label on DailyMed.
Highlights of the record
FDA label of March 24, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY,.
and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID ® treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment [see Warnings and Precautions ( 5.1 ), and Medication Guide ( 17 )]. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the Lenalidomide REMS program ( 5.2 ). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the REMS Call Center at 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. […]
Used for
From the label: indications and usageREVLIMID is a thalidomide analogue indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ).
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 15 mg
- 20 mg
- 25 mg
Capsule.
On the market
- Earliest approval on file
- December 27, 2005 Revlimid, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first May 21, 2021; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 8, 2028 Revlimid capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 420,082 through July 30, 2026
What is lenalidomide used for?
From the label: indications and usageREVLIMID 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 follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). […]
Conditions named in the indications of lenalidomide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Thalidomide Analog.
Source: FDA drug label (Revlimid), NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), via openFDA; the full label on DailyMed
What does the patient leaflet for lenalidomide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about REVLIMID?Before you begin taking REVLIMID, you must read and agree to all of the instructions in the Lenalidomide REMS program. For more information, call 1-888-423-5436 or go to www.lenalidomiderems.com. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide REMS program to you and have you sign the Patient-Physician Agreement Form. REVLIMID may cause serious side effects including: • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide. We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. […]
From the patient leaflet: What should I avoid while taking REVLIMID?See "What is the most important information I should know about REVLIMID?" • Females: Do not get pregnant and do not breastfeed while taking REVLIMID. • Males: Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping REVLIMID. • Do not share REVLIMID with other people. It may cause birth defects and other serious problems. • Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.
From the patient leaflet: How should I store REVLIMID?Store REVLIMID at room temperature between 68°F to 77°F (20°C to 25°C). • Return any unused REVLIMID to Bristol-Myers Squibb or your healthcare provider. Keep REVLIMID and all medicines out of the reach of children.
Source: FDA drug label (Revlimid), NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), via openFDA; the full label on DailyMed
Is there a generic for lenalidomide (Revlimid)?
The FDA approved the first generic lenalidomide on May 21, 2021. 20 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lenalidomide from 18 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Revlimid capsules: the compound patent runs to April 27, 2027, and the last listed entry to March 8, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2021 first generic approved
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lenalidomide label say about other medicines?
The lenalidomide label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name lenalidomide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlorambucil | warnings and precautions | Mortality in Patients with CLL In a prospective randomized (1:1) clinical trial in the first line treatment of patients with chronic lymphocytic leukemia, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. |
| Cyclophosphamide | warnings and precautions | In patients who received more than 4 cycles of a REVLIMID-containing treatment or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of G-CSF with a CXCR4 inhibitor may be considered. |
| Dexamethasone | boxed warning | Venous and Arterial Thromboembolism REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with REVLIMID and dexamethasone therapy. |
| Digoxin | drug interactions | Monitor digoxin plasma levels periodically due to increased C max and AUC with concomitant REVLIMID therapy ( 7.1 ). |
| Melphalan | warnings and precautions | An increase in hematologic SPM including AML and MDS occurred in 5.3% of patients with NDMM receiving REVLIMID in combination with oral melphalan compared with 1.3% of patients receiving melphalan without REVLIMID. |
| Pembrolizumab | warnings and precautions | Increased Mortality: Observed in patients with MM when pembrolizumab was added to dexamethasone and a thalidomide analogue ( 5.7 ). |
| Rituximab | warnings and precautions | TLS occurred in 1 patient (0.5%) in the MAGNIFY trial during the REVLIMID/rituximab induction period; the event was a serious, Grade 3 adverse reaction. |
| Thalidomide | boxed warning | Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. |
| Warfarin | drug interactions | Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin. |
Other labels that name lenalidomide
Source: FDA drug label (Revlimid), NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), via openFDA; the full label on DailyMed
What do FAERS reports show for lenalidomide?
The FDA Adverse Event Reporting System holds 420,082 reports that list lenalidomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53,763 are coded as a death and 109,169 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lenalidomide?
38 other medicines are given the same way (oral) and in the same FDA class as lenalidomide or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Prednisolone | Leukemia, lymphoma and myeloma, Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Every medicine labeled for the same conditions as lenalidomide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lenalidomide compare with medicines for the same use?
1 side-by-side page set lenalidomide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lenalidomide
- 38 medicines for the same use
- Other thalidomide analogs
- the pharmacologic class, with prices and generics
- Lenalidomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other