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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.

Brand name Revlimid
Drug class Thalidomide Analog
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 4, 2026
Lenalidomide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

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.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record2005
Companies listing it with the FDA19
FDA label last updatedMar 24, 2023
FDA’s strongest warning (boxed)Yes, read the warning

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 →

70

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.

Severity mix
  • Major · 1
  • Moderate · 59
  • Minor · 10
Every supplement checked against Lenalidomide — ranked by severity The full interaction hub: 1 major · 59 moderate · 10 minor · every one linked to its full report. Check Lenalidomide against your exact supplements

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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Lenalidomide is the active ingredient in both Revlimid and the generic version called Lenalidomide — they are the same medicine. Depending on your diagnosis, your doctor may prescribe it to treat multiple myeloma, certain myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, or marginal zone lymphoma. You only take one version — whichever your prescriber and pharmacy provide through the required safety program.

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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Because lenalidomide can cause severe birth defects or kill an unborn baby, it's only available through a strictly controlled program called the Lenalidomide REMS program. Everyone involved — your prescriber, the pharmacy, and you — has to be enrolled and follow specific rules. This includes pregnancy testing for women who could become pregnant and contraception requirements for both men and women. It's not meant to make your life harder — it's a real safety measure to protect anyone who could be harmed by accidental exposure.

What side effects should I expect, and which ones mean I need to call someone right away?

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The most common side effects include diarrhea, fatigue, constipation, nausea, rash, and swelling in your legs. Low blood cell counts are also very common — your doctor will check your blood regularly to catch any drops early. What you should act on immediately: shortness of breath, chest pain, or significant leg swelling (possible blood clot), signs of infection like fever or chills, unusual bleeding or bruising, or any severe skin reaction like blistering or peeling. These aren't things to wait and see about — call your doctor or go to the ER right away.

Can I take this capsule with food, or does it matter?

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You can take lenalidomide capsules with or without food — it's your choice. While a very high-fat meal can slightly reduce the amount your body absorbs, the clinical trials that proved the drug works were done without any food restrictions. Just try to take it at roughly the same time each day as your prescriber recommends.

I'm a man taking this drug — do the pregnancy warnings apply to me too?

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Yes, absolutely. Lenalidomide is found in semen, which means a woman could be exposed through sexual contact. You must use a latex or synthetic condom every time you have sexual contact with a woman who could become pregnant — even if you've had a vasectomy. This continues during treatment and for up to 4 weeks after your last dose. You also cannot donate sperm during treatment or for 4 weeks after stopping. These aren't optional steps — they're part of the required safety program.

My kidneys aren't working perfectly — does that affect how I take this medication?

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Yes, kidney function matters a lot with lenalidomide because the drug is mainly cleared from your body through your kidneys. If your kidneys aren't working at full capacity, the drug can build up and cause more side effects. Your doctor will check your kidney function before you start and will adjust your starting dose accordingly. Make sure your care team always knows about any changes in your kidney health.

Is Lenalidomide available over the counter?

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No. Lenalidomide is a prescription medicine: every Lenalidomide product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lenalidomide first available?

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The earliest FDA record we hold for Lenalidomide is from 2005: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lenalidomide was first used.

Who makes Lenalidomide?

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19 companies currently list Lenalidomide products in the FDA's NDC Directory, including Accord Healthcare Inc., Alvogen, Inc., Amneal Pharmaceuticals NY LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lenalidomide on HelloPharmacist

Detailed data & references for Lenalidomide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

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

By mouth
Brands Revlimid
How this form is used
What it may be used for
  • 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
Important instructions
  • 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
Available strengths 6 strengths
219 FDA-listed product records ⓘ

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.

1
Dose forms ⓘ
19
Labelers (makers, repackagers, distributors)
2
Brand names
114
FDA-listed product records ⓘ
2005
Earliest FDA record ⓘ

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.

Accord Healthcare Inc.5%
Alvogen, Inc.5%
Amneal Pharmaceuticals NY LLC5%
Apotex Corp.5%
Aurobindo Pharma Limited5%
Biocon Pharma Inc.,5%
Other makers68%

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.

15,430
Medicaid prescriptions filled (Q1–Q4 2025)
$250.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lenalidomide prescribed? Of the 1,601 medications we measure, Lenalidomide ranks #851 by Medicaid prescriptions — more than 47% of them.

Where Lenalidomide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

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.

The 10 mg oral capsule is the most-dispensed Lenalidomide product — about 56% of these Medicaid prescriptions.

lenalidomide 10 MG Oral Capsule Most dispensed

8,686 Medicaid prescriptions (Q1–Q4 2025) 56% of Lenalidomide prescriptions shown $146.5M gross reimbursement (before rebates) ≈ $16,868 per prescription (gross)

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

3,053 Medicaid prescriptions (Q1–Q4 2025) 20% of Lenalidomide prescriptions shown $43M gross reimbursement (before rebates) ≈ $14,081 per prescription (gross)

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

1,783 Medicaid prescriptions (Q1–Q4 2025) 12% of Lenalidomide prescriptions shown $30.7M gross reimbursement (before rebates) ≈ $17,213 per prescription (gross)

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

1,614 Medicaid prescriptions (Q1–Q4 2025) 10% of Lenalidomide prescriptions shown $26.2M gross reimbursement (before rebates) ≈ $16,245 per prescription (gross)

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

274 Medicaid prescriptions (Q1–Q4 2025) 2% of Lenalidomide prescriptions shown $4.2M gross reimbursement (before rebates) ≈ $15,222 per prescription (gross)

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

20 Medicaid prescriptions (Q1–Q4 2025) <1% of Lenalidomide prescriptions shown $265,868 gross reimbursement (before rebates) ≈ $13,293 per prescription (gross)

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.)

Showing 108 of 114 products — FDA National Drug Code Directory. See every product, package size and price: browse all 114 Lenalidomide NDCs →

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 2021

Source: 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.

Ingredient (IN) Lenalidomide RxCUI 342369 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 602909 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 1242231 5 MG RxCUI 602912 10 MG RxCUI 602910 15 MG RxCUI 643712 20 MG RxCUI 1428947 25 MG RxCUI 643720

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 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.

Revlimid

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.

Accord Healthcare Inc. 6 Alvogen, Inc. 6 Amneal Pharmaceuticals NY LLC 6 Apotex Corp. 6 Aurobindo Pharma Limited 6 Biocon Pharma Inc., 6 Camber Pharmaceuticals, Inc. 6 Celgene Corporation 6 Cipla USA Inc. 6 Devatis Inc. 6 Dr. Reddy's Laboratories Inc. 6 Exelan Pharmaceuticals Inc. 6 Mylan Pharmaceuticals Inc. 6 Novugen Pharma (USA) LLC 6 Padagis US LLC 6 Sun Pharmaceutical Industries, Inc. 6 Teva Pharmaceuticals, Inc. 6 Zydus Lifesciences Limited 6 Zydus Pharmaceuticals USA Inc. 6

Lenalidomide drug class (RxNorm)

Lenalidomide belongs to the Thalidomide Analog class.

Pharmacologic class Thalidomide Analog
Drug family (ATC) Other immunosuppressants

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 24, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lenalidomide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lenalidomide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
Finished products in the current FDA directory
114
Companies listing them (makers, repackagers, distributors)
19
FDA labeler codes behind them ⓘ
19
Linked representative label ⓘ
Celgene Corporation
Linked label effective
Mar 24, 2023
Composite sections available
25
Linked SPL Set ID
5fa97bf5-28a2-48f1-8955-f56012d296be
Linked SPL Document ID
b5eadec8-aa2b-43ec-b0d6-e5b0c3da08cb
Open the linked representative label on DailyMed ↗

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 →