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Lenalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 28, 2025.

Applies to lenalidomide: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Embryo-Fetal Toxicity, Hematologic Toxicity, and Venous and Arterial Thromboembolism. Embryo-Fetal Toxicity. Do not use lenalidomide 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 lenalidomide treatment.

Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide treatment.

To avoid embryo-fetal exposure to lenalidomide, lenalidomide is only available through a restricted distribution program, the Lenalidomide REMS programInformation about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the manufacturer’s toll-free number 1-888-423-5436Hematologic Toxicity (Neutropenia and Thrombocytopenia)Lenalidomide 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.

Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study.

Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter.

Patients may require dose interruption and/or reduction.

Patients may require use of blood product support and/or growth factors.Venous and Arterial Thromboembolism. Lenalidomide 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 lenalidomide and dexamethasone therapy.

Monitor for and advise patients about signs and symptoms of thromboembolism.

Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling.

Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.

Precautions

It is very important that your doctor check your progress closely at regular visits to see if the medicine is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.

Women should take the necessary precautions to avoid pregnancy while using lenalidomide. Begin 2 forms of reliable contraception 4 weeks before starting lenalidomide. Continue contraceptive measures during treatment and for at least 4 weeks after the last dose. Routine pregnancy tests are necessary with this medicine. Call your doctor for emergency contraception information if you think you are pregnant.

Men, even those who have had a vasectomy, must prevent pregnancy in their sexual partners during treatment with this medicine and for at least 4 weeks after the last dose. Do not donate sperm while using this medicine. Call your doctor for emergency contraception information if you think your sexual partner may be pregnant.

Do not donate blood during treatment and for at least 4 weeks after the last dose.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of having blood clots. Check with your doctor right away if you have anxiety, chest pain, fainting, a fast heartbeat, trouble breathing, or pain, redness, or swelling in the arm or leg.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, high cholesterol, or if you smoke. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea, vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, or trouble breathing.

Do not receive pembrolizumab together with dexamethasone and lenalidomide or similar medicines if you have multiple myeloma.

Serious liver problems can occur with this medicine. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow skin or eyes.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are using this medicine.

Lenalidomide may cause a serious type of reaction called tumor lysis syndrome. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may increase your risk of getting certain cancers (eg, acute myelogenous leukemia, myelodysplastic syndrome). Talk to your doctor if you have concerns about this risk.

This medicine may cause a tumor flare reaction. Tell your doctor if you have swollen and painful lymph nodes, a mild fever, pain, or a rash.

This medicine may cause a serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or trouble swallowing after using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of lenalidomide

Along with its needed effects, lenalidomide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lenalidomide:

More common side effects

  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain or tightness
  • chills
  • cough
  • decreased urine
  • difficult or labored breathing
  • dry mouth
  • fever
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Less common side effects

  • burning or stinging of the skin
  • chest discomfort
  • confusion
  • difficulty with speaking
  • dilated neck veins
  • double vision
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irregular breathing
  • pain or discomfort in the arms, jaw, back or neck
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • slow speech
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • weight gain

Incidence not known

  • anxiety
  • blistering, peeling, or loosening of the skin
  • clay-colored stools
  • dark urine
  • depressed mood
  • diarrhea
  • difficulty having a bowel movement
  • difficulty swallowing
  • dizziness or lightheadedness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • general feeling of tiredness or weakness
  • hair loss
  • hives, itching, skin rash
  • hoarseness or husky voice
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramps and stiffness
  • pain, redness, or swelling in the arm or leg
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • slowed heartbeat
  • stomach pain, continuing
  • swelling of the feet or lower legs
  • trouble sleeping
  • trouble breathing
  • unpleasant breath odor
  • vomiting of blood
  • weight loss
  • yellow eyes or skin

Other side effects of lenalidomide

Some side effects of lenalidomide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • abnormal or decreased touch sensation
  • bloody nose
  • blurred vision
  • body aches or pain
  • burning feeling while urinating
  • burning, numbness, tingling, or painful sensations
  • change in taste
  • cough-producing mucus
  • difficulty with moving
  • drowsiness or tiredness
  • ear congestion
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • flushing or redness of the skin
  • increased sweating or night sweats
  • irritability
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lack or loss of strength
  • large, flat, blue or purplish patches in the skin
  • loose stools
  • loss of interest or pleasure
  • muscle spasms or twitching
  • pain or tenderness around the eyes and cheekbones
  • shivering
  • tender, swollen glands in the neck
  • trembling
  • trouble concentrating
  • unsteadiness or awkwardness
  • upper abdomen or stomach pain
  • voice changes
  • weakness in the arms, hands, legs, or feet

Incidence not known

  • feeling of constant movement of self or surroundings
  • sensation of spinning

For healthcare professionals

Applies to lenalidomide: oral capsule.

Hematologic adverse events

Gastrointestinal

Respiratory

Other

Dermatologic

Musculoskeletal

Psychiatric

Nervous system

Metabolic

Ocular

Hepatic

Genitourinary

Endocrine

Cardiovascular

Oncologic

Renal

Hypersensitivity

See also:

References

1. (2006) "Product Information. Revlimid (lenalidomide)." Celgene Corporation

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Lenalidomide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.