Lenalidomide
Lenalidomide is an oral cancer medicine used to treat multiple myeloma, certain myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 21 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Lenalidomide (Revlimid), a thalidomide relative on the market since about 2005 and available as a generic, is a mainstay oral medicine for multiple myeloma and treats certain myelodysplastic syndromes and lymphomas, working by making cancer cells break down proteins they rely on and by activating the immune system. Many people manage it fairly well, though tiredness, diarrhea or constipation, and ankle swelling are common. Its boxed warning covers severe birth defects and fetal death, dangerous drops in blood counts, and blood clots including leg and lung clots, heart attack and stroke, so it is dispensed only through a restricted safety program (REMS) with strict pregnancy prevention for women and men.
Clinical pearls
- Expect frequent blood counts early on, and call right away for fever or chills, because low white cells make infections dangerous.
- Many people also take a preventive blood thinner, and chest pain, shortness of breath, or a swollen arm or leg needs emergency care.
- Men must use a latex or synthetic condom with partners who could become pregnant, even after a vasectomy.
- Estrogen-containing medicines and red blood cell boosters add to the clot risk, and digoxin levels can rise, so mention them.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Lenalidomide has three serious FDA boxed warnings — the most severe type of safety warning.
Birth defects and fetal death: Lenalidomide is closely related to thalidomide, a drug notorious for causing devastating birth defects. Lenalidomide must never be used during pregnancy. Women who could become pregnant must take two pregnancy tests before starting, use two forms of birth control (or abstain completely) throughout treatment and for 4 weeks after, and be tested for pregnancy regularly. Because of this risk, lenalidomide is only dispensed through a strictly controlled safety program called the Lenalidomide REMS program.
Dangerous drops in blood counts: Lenalidomide can severely lower white blood cell and platelet counts, increasing the risk of serious infections and bleeding. In patients with MDS, 80% experienced significant blood count problems. Regular blood tests are required throughout treatment.
Blood clots: Patients with multiple myeloma taking lenalidomide with dexamethasone have a meaningfully higher risk of developing blood clots in the legs or lungs, as well as heart attack and stroke. Seek emergency care immediately for shortness of breath, chest pain, or limb swelling.
Patient information guide A plain-language walkthrough of Lenalidomide, written from its FDA label.
What Lenalidomide is used for
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Lenalidomide capsules are approved for several blood cancers and related conditions in adults.
- Multiple myeloma (MM): Revlimid and Lenalidomide capsules are used in combination with dexamethasone to treat MM. They are also approved as maintenance therapy after an autologous hematopoietic stem cell transplant (auto-HSCT).
- Myelodysplastic syndromes (MDS): Revlimid and Lenalidomide capsules treat transfusion-dependent anemia in adults with low- or intermediate-1-risk MDS that is linked to a deletion 5q chromosome abnormality.
- Mantle cell lymphoma (MCL): Revlimid and Lenalidomide capsules are used for adults whose MCL has relapsed or progressed after two prior therapies, one of which must have included bortezomib.
- Follicular lymphoma (FL): Revlimid and Lenalidomide capsules are used in combination with a rituximab product for adults with previously treated FL.
- Marginal zone lymphoma (MZL): Revlimid and Lenalidomide capsules are used in combination with a rituximab product for adults with previously treated MZL.
- Not for CLL: Lenalidomide capsules are not approved for chronic lymphocytic leukemia outside of clinical trials.
How Lenalidomide works
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Lenalidomide latches onto a protein called cereblon inside cancer cells. Cereblon is part of an enzyme system that tags other proteins for disposal. With lenalidomide attached, key proteins that blood cancer cells depend on — including Aiolos, Ikaros, and CK1α — get flagged for destruction. This directly kills cancer cells and stops them from multiplying. Lenalidomide also supercharges the immune system, activating T cells and natural killer (NK) cells that can recognize and destroy cancer cells, and it reduces inflammatory signals that tumors use to survive.
When lenalidomide is combined with dexamethasone in multiple myeloma, the two drugs work together more powerfully to stop cancer cell growth and trigger cell death. When combined with rituximab in follicular or marginal zone lymphoma, lenalidomide amplifies rituximab's ability to direct immune cells to destroy tumor cells.
Lenalidomide dosage
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Lenalidomide capsules are taken by mouth once daily. The exact schedule — whether every day or on specific days within a repeating 28-day cycle — depends on the condition being treated. For example, some regimens involve taking the capsule on Days 1–21 of each 28-day cycle, while maintenance therapy for multiple myeloma after a stem cell transplant may be taken continuously every day. Capsules can be taken with or without food.
- Your prescriber will set your dose and schedule based on your diagnosis, kidney function, and how well you tolerate the drug.
- Blood counts are monitored regularly, and dose pauses or reductions are common — never adjust your dose on your own.
- If you miss a dose, follow the guidance on your prescription label or ask your pharmacist or doctor what to do.
Dosing details from the FDA-approved label
From the Lenalidomide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- MM combination therapy
- 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone
- For patients greater than 75 years old, the starting dose of dexamethasone may be reduced
- MM maintenance therapy following auto-HSCT
- 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles
- After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated
- Initiate after adequate hematologic recovery (ANC at least 1,000/mcL and/or platelet counts at least 75,000/mcL)
- MDS
- 10 mg once daily
- Treatment is continued or modified based upon clinical and laboratory findings
- MCL
- 25 mg once daily orally on Days 1-21 of repeated 28-day cycles
- FL or MZL
- 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles
- Renal impairment
- Adjust starting dose based on the creatinine clearance value
- Adjust starting dose based on creatinine clearance
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • MM combination therapy: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles ( 2.1 ). • MM maintenance therapy following auto-HSCT: 10 mg once daily continuously on Days 1-28 of repeated 28-day cycles ( 2.1 ). • MDS: 10 mg once daily ( Error! Hyperlink reference not valid. ). • MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles ( 2.3 ). • FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to 12 cycles ( 2.4 ). • Renal impairment: Adjust starting dose based on the creatinine clearance value ( 2.6 ). • For concomitant therapy doses, see Full Prescribing Information ( 2.1 , 2.4 , 14.1 , 14.4 ). 2.1 Recommended Dosage for Multiple Myeloma Lenalidomide Capsule Combination Therapy The recommended starting dose of lenalidomide capsules is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies (14.1) ] . Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a lenalidomide capsule-containing therapy [see Warnings and Precautions (5.12) ] . Dose Adjustments for Hematologic Toxicities During MM Treatment Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to lenalidomide capsules. Table 1: Dose Adjustments for Hematologic Toxicities for MM Platelet Counts Thrombocytopenia in MM When Platelets Recommended Course Days 1-21 of Repeated 28-day Cycle Fall below 30,000/mcL Interrupt lenalidomide capsule treatment, follow CBC weekly Return to at least 30,000/mcL Resume lenalidomide capsules at next lower dose. Do not dose below 2.5 mg daily For each subsequent drop below 30,000/mcL Interrupt lenalidomide capsule treatment Return to at least 30,000/mcL Resume lenalidomide capsules at next lower dose.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lenalidomide side effects
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Lenalidomide commonly causes blood count changes and digestive and general symptoms across its approved uses.
Common side effects
- Diarrhea
- Fatigue or weakness
- Constipation
- Nausea
- Low white blood cell counts (neutropenia) — raising infection risk
- Low platelet counts (thrombocytopenia) — raising bleeding risk
- Peripheral edema (swelling in the legs or ankles)
- Rash or itching
- Diarrhea, constipation, nausea, and stomach pain
- Anemia (low red blood cells)
- Muscle cramps, back pain, dizziness, cough, and fever
When to get medical help
- Get emergency help right away if you have shortness of breath, chest pain, or swelling in an arm or leg — these can be signs of a dangerous blood clot
- Call your doctor immediately if you have signs of infection: fever, chills, or unusual weakness
- Seek medical care right away for unusual bleeding or bruising
- Contact your doctor if you develop severe skin reactions such as blistering, peeling, or widespread rash
- Tell your doctor right away if you notice yellowing of the skin or eyes, or dark urine — these may be signs of liver problems
- If you are pregnant or think you might be pregnant, stop taking lenalidomide and contact your doctor immediately — this drug can cause severe birth defects or fetal death
Serious reactions — including dangerous blood clots, severe skin reactions, liver damage, and infections like pneumonia — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these arise.
Lenalidomide warnings and precautions
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- Birth defects and fetal death: Lenalidomide can cause catastrophic birth defects or kill an unborn baby. It must never be taken during pregnancy. Women of childbearing potential need two negative pregnancy tests before starting, and must use two forms of birth control throughout treatment and for 4 weeks after. Men must use a condom during sexual contact with a woman who could become pregnant, during treatment and for 4 weeks after stopping.
- Low blood counts: Lenalidomide frequently causes dangerous drops in white blood cells and platelets. This raises the risk of serious infections and significant bleeding. Frequent blood tests are required, especially early in treatment.
- Blood clots: Multiple myeloma patients taking lenalidomide with dexamethasone face a meaningfully higher risk of deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke. Preventive blood-thinning therapy is usually recommended. Get emergency help for shortness of breath, chest pain, or limb swelling.
- Second cancers: Higher rates of new (second primary) cancers have been observed in controlled trials of multiple myeloma patients receiving lenalidomide.
- Liver damage: Hepatic failure, including fatalities, has occurred. Liver function is monitored during treatment.
- Severe skin reactions: Serious reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis can occur. Lenalidomide must be stopped if these develop.
- Early death in MCL: A higher rate of early deaths has been seen in mantle cell lymphoma patients treated with lenalidomide.
Lenalidomide interactions
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Lenalidomide has a few clinically important interactions to be aware of.
- Digoxin (heart medication): Lenalidomide can raise digoxin blood levels, increasing the risk of digoxin toxicity — your doctor will monitor digoxin levels during treatment.
- Erythropoiesis-stimulating agents (drugs that boost red blood cell production): Using these alongside lenalidomide may further raise the risk of dangerous blood clots.
- Estrogen-containing therapies (such as some hormonal contraceptives or hormone replacement therapies): These may also add to blood clot risk when used with lenalidomide.
- Warfarin: Although lenalidomide itself doesn't appear to change how warfarin works, dexamethasone (commonly given with lenalidomide for multiple myeloma) may interact with warfarin — close monitoring of clotting labs (PT/INR) is recommended.
Interactions listed in the FDA-approved label
From the Lenalidomide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Digoxin: When co-administered with multiple doses of lenalidomide capsules (10 mg/day), digoxin Cmax and AUCinf were increased by 14%. Periodically monitor digoxin plasma levels, in accordance with clinical judgment and standard clinical practice.
- Erythropoietic agents and estrogen containing therapies: Concomitant use with lenalidomide capsules may increase the risk of thrombosis. Use with caution after making a benefit-risk assessment.
- Warfarin: Multiple doses of lenalidomide capsules (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin; expected PT and INR changes were not affected by lenalidomide. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.
- Dexamethasone: Single or multiple doses of dexamethasone (40 mg) had no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide capsules (25 mg).
- P-gp inhibitors (quinidine): Lenalidomide capsules (25 mg) after multiple doses of quinidine (600 mg twice daily) did not significantly increase the Cmax or AUC of lenalidomide.
- Temsirolimus: Co-administration of temsirolimus (25 mg) with lenalidomide capsules (25 mg) did not significantly alter the pharmacokinetics of lenalidomide, temsirolimus, or sirolimus.
- CYP450 isoenzymes: Lenalidomide does not inhibit or induce CYP450 isoenzymes.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Digoxin: Monitor digoxin plasma levels periodically due to increased C max and AUC with concomitant lenalidomide capsule therapy ( 7.1 ). • Concomitant use of erythropoietin stimulating agents or estrogen containing therapies with lenalidomide capsules may increase the risk of thrombosis ( 7.2 ). 7.1 Digoxin When digoxin was co-administered with multiple doses of lenalidomide capsules (10 mg/day) the digoxin C max and AUC inf were increased by 14%. Periodically monitor digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, during administration of lenalidomide capsules. 7.2 Concomitant Therapies That May Increase the Risk of Thrombosis Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving lenalidomide capsules [see Warnings and Precautions (5.4) ] . 7.3 Warfarin Co-administration of multiple doses of lenalidomide capsules (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin. Expected changes in laboratory assessments of PT and INR were observed after warfarin administration, but these changes were not affected by concomitant lenalidomide capsule administration. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin.
Drug Interactions Co-administration of a single dose or multiple doses of dexamethasone (40 mg) had no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide capsules (25 mg). Co-administration of lenalidomide capsules (25 mg) after multiple doses of a P-gp inhibitor such as quinidine (600 mg twice daily) did not significantly increase the C max or AUC of lenalidomide.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Lenalidomide
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- Pregnancy: Lenalidomide is absolutely contraindicated in pregnancy — it can cause severe birth defects or fetal death. Women of childbearing age must follow strict pregnancy prevention requirements and testing throughout treatment.
- Breastfeeding: Do not breastfeed while taking lenalidomide. It is not known whether the drug passes into breast milk, but the risk to a nursing infant is considered significant.
- Kidney disease: The starting dose must be adjusted in patients with reduced kidney function (renal impairment). Tell your doctor if you have any kidney problems.
- Severe allergic reactions: Lenalidomide must not be used by anyone who has had a serious allergic reaction (such as angioedema, Stevens-Johnson syndrome, or toxic epidermal necrolysis) to it previously.
- Children: Safety and effectiveness have not been established in patients under 18 years of age.
- Older adults: Patients over 75 may experience higher rates of serious side effects, including infections, heart problems, and kidney issues, and should be monitored closely.
- Blood or sperm donation: Do not donate blood or sperm during treatment or for 4 weeks after stopping, to prevent exposure of others to the drug.
Lenalidomide overdose
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There is no established treatment specifically for a lenalidomide overdose. In studies where healthy subjects received very high doses, the main problems reported were itching, hives, rash, and elevated liver enzymes. In clinical trials, the dose-limiting toxicities were low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). If you think you or someone else has taken too much, contact a poison control center or seek emergency medical care right away.
What Lenalidomide does in the body
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At doses up to twice the maximum recommended dose, lenalidomide did not meaningfully prolong the QTc interval (a measure of heart electrical activity), based on a dedicated study in healthy subjects. This means lenalidomide is not expected to cause the type of heart rhythm problems sometimes seen with other medications that affect the QTc interval.
How your body processes Lenalidomide
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Lenalidomide capsules are absorbed through the gut, with peak blood levels typically reached within 30 minutes to 6 hours after a dose. Food — especially a high-fat meal — can reduce the amount absorbed, but since the clinical trials were conducted without regard to food, the capsules can be taken with or without food. The drug is eliminated mainly by the kidneys, with about 82% excreted unchanged in the urine within 24 hours; only a small portion is broken down into other compounds. The half-life (how long it takes the body to clear half the drug) is about 3 hours in healthy people and 3 to 5 hours in patients with multiple myeloma, MDS, or MCL. In patients with significant kidney disease, the drug stays in the body much longer and the dose must be adjusted accordingly. Lenalidomide does not build up in the body with repeated dosing at recommended doses.
How to store Lenalidomide
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Lenalidomide
70 supplements and herbal products have documented interactions with Lenalidomide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 59
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Lenalidomide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lenalidomide — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is lenalidomide used for — and do I need both Revlimid and the generic?
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I heard this drug is really hard to get — why do I have to jump through so many hoops just to fill my prescription?
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What side effects should I expect, and which ones mean I need to call someone right away?
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Can I take this capsule with food, or does it matter?
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I'm a man taking this drug — do the pregnancy warnings apply to me too?
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My kidneys aren't working perfectly — does that affect how I take this medication?
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Is Lenalidomide available over the counter?
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When was Lenalidomide first available?
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Who makes Lenalidomide?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Lenalidomide on HelloPharmacist
Lenalidomide forms and strengths (how it comes)
Lenalidomide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Revlimid and Lenalidomide capsules treat multiple myeloma in adults, both in combination with dexamethasone and as maintenance therapy after an autologous stem cell transplant
- Revlimid and Lenalidomide capsules treat transfusion-dependent anemia from low- or intermediate-1-risk myelodysplastic syndromes (MDS) with a deletion 5q chromosome change
- Revlimid and Lenalidomide capsules treat mantle cell lymphoma (MCL) that has relapsed or progressed after two prior therapies, one of which included bortezomib
- Revlimid and Lenalidomide capsules treat previously treated follicular lymphoma and marginal zone lymphoma, each in combination with a rituximab product
- Revlimid and Lenalidomide capsules are taken by mouth once daily — the schedule (daily or on set days within a 28-day cycle) depends on the condition being treated; follow your prescriber's instructions exactly
- Revlimid and Lenalidomide capsules can be taken with or without food
- Revlimid and Lenalidomide capsules are only dispensed through the Lenalidomide REMS program — patients must be enrolled and meet all program requirements before a pharmacy can dispense them
- Dose adjustments or temporary stops are common, especially if blood counts drop — never change your dose without your doctor's guidance
Lenalidomide on the U.S. market: products, makers and brands
How Lenalidomide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
19 companies list 114 Lenalidomide product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2005. Brand names on the directory include Revlimid; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (21) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Lenalidomide is used (Medicaid data)
A general measure of how commonly Lenalidomide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lenalidomide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lenalidomide prescribed? Of the 1,601 medications we measure, Lenalidomide ranks #851 by Medicaid prescriptions — more than 47% of them.
Utilization by Lenalidomide product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lenalidomide 10 MG Oral Capsule Most dispensed
Summed across the 13 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 602910
lenalidomide 25 MG Oral Capsule
Summed across the 12 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 643720
lenalidomide 5 MG Oral Capsule
Summed across the 8 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 602912
lenalidomide 15 MG Oral Capsule
Summed across the 7 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 643712
lenalidomide 20 MG Oral Capsule
Summed across the 6 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1428947
lenalidomide 2.5 MG Oral Capsule
Summed across the 1 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1242231
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lenalidomide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 47 of 196 listed Lenalidomide NDCs with Medicaid activity.
Compare Lenalidomide products
A representative set of FDA-listed product records for Lenalidomide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 2.5 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 5 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 10 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 15 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 20 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 25 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Alvogen, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 10 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 15 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 20 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 25 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 5 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 10 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 15 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 20 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 25 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 15 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 25 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 5 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 10 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 15 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 20 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 25 mg | Oral | Biocon Pharma Inc., | ANDA | View NDC → |
| 2.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 5 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 10 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 15 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 20 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 25 mg | Oral | Celgene Corporation | NDA | View NDC → |
| 2.5 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 5 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 15 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 20 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 25 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 5 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 10 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 15 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 20 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 25 mg | Oral | Devatis Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 5 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 10 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 15 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 20 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 25 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Exelan Pharmaceuticals Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 5 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 10 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 15 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 20 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 25 mg | Oral | Novugen Pharma (USA) LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 5 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 10 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 15 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 20 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 25 mg | Oral | Padagis US LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 15 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 10 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 15 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 20 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 25 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
Showing 108 of 114 products — FDA National Drug Code Directory. See every product, package size and price: browse all 114 Lenalidomide NDCs →
Lenalidomide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lenalidomide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lenalidomide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Lenalidomide FDA approval history
How Lenalidomide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Lenalidomide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Lenalidomide recalls since July 2021.
✅No Lenalidomide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 342369 1 dose form · 6 strengths
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Dose form (SCDF) Oral Capsule RxCUI 602909In current FDA listings
Look up RxCUI 342369 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Lenalidomide supply and shortage status
Whether Lenalidomide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Lenalidomide brand names
Lenalidomide is sold under one brand name in the FDA directory — Revlimid. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Lenalidomide: manufacturers and labelers
19 companies list Lenalidomide products with the FDA. By number of product records, the largest are Accord Healthcare Inc., Alvogen, Inc., Amneal Pharmaceuticals NY LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lenalidomide drug class (RxNorm)
Lenalidomide belongs to the Thalidomide Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Lenalidomide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Celgene Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →