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.

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

• Very common (10% or more): Neutropenia (79%), thrombocytopenia (72%), anemia (44%), leukopenia (32%), lymphopenia (18%), neutropenic infection (18%), febrile neutropenia (17%)
• Common (1% to 10%): Pancytopenia, autoimmune hemolytic anemia
• Uncommon (0.1% to 1%): Hypercoagulation
• Frequency not reported: Warm type hemolytic anemia, splenic infarction, bone marrow depression, coagulopathy, hemolysis, refractory anemia, decreased hemoglobin, acquired hemophilia^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (55%), constipation (41%), nausea (26%), gastroenteritis (23%), abdominal pain (21%), vomiting (12%), dyspepsia (11%)
• Common (1% to 10%): Upper abdominal pain, dry mouth, gastrointestinal hemorrhage, glossodynia, loose stools, toothache
• Uncommon (0.1% to 1%): Cecitis
• Frequency not reported: Clostridium difficile colitis, ischemic colitis, intestinal perforation, rectal hemorrhage, colonic polyp, diverticulitis, dysphagia, gastritis, gastroenteritis, gastroesophageal reflux disease, obstructive inguinal hernia, irritable bowel syndrome, melena, pancreatitis, perirectal abscess, small intestinal obstruction, upper gastrointestinal hemorrhage, oral infection, pelvic pain^[Ref]

Respiratory

• Very common (10% or more): Bronchitis (47%), nasopharyngitis (35%), cough (28%), upper respiratory tract infection (27%), dyspnea (24%), pneumonia (18%), pharyngitis (16%), rhinitis (15%), epistaxis (15%), sinusitis (14%), oropharyngeal pain (10%)
• Common (1% to 10%): Respiratory tract infection, lung infection, lower respiratory tract infection, bacterial lower respiratory tract infection, exertional dyspnea, rhinorrhea, pulmonary embolism, respiratory distress, hoarseness, pleural effusion, hypoxia
• Frequency not reported: Chronic obstructive pulmonary disease, pulmonary edema, lobar pneumonia, respiratory failure, interstitial lung disease, lung infiltration, wheezing
• Postmarketing reports: Pneumonitis^[Ref]

Other

• Very common (10% or more): Fatigue (44%), asthenia (30%), pyrexia (28%), peripheral edema (26%), influenza (13%), edema (10%)
• Common (1% to 10%): Non-cardiac chest pain, sepsis, Staphylococcal sepsis, fall, infection, bacteremia, herpes zoster, lethargy, malaise, pain, rigors, general physical health deterioration, chills, deafness (including hypoacusis), tinnitus
• Frequency not reported: Disease progression, abnormal gait, intermittent pyrexia, nodule, sudden death, central line infection, clostridial infection, ear infection, Enterobacter sepsis, fungal infection, Klebsiella sepsis, localized infection, Pseudomonas infection, septic shock, transfusion reaction, overdose, post procedural hemorrhage, road traffic accident
• Postmarketing reports: Viral reactivation^[Ref]

Dermatologic

• Very common (10% or more): Pruritus (42%), rash (36%), dry skin (14%), hyperhidrosis (10%)
• Common (1% to 10%): Cellulitis, hirsutism, exanthema, skin hyperpigmentation, contusion, night sweats, ecchymosis, erythema, urticarial, eczema
• Uncommon (0.1% to 1%): Photosensitivity reaction
• Frequency not reported: Acute febrile neutrophilic dermatosis
• Postmarketing reports: Stevens-Johnson Syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle cramp (33%), muscle spasms (33%), back pain (32%), arthralgia (22%), bone pain (16%), pain in extremity (15%), musculoskeletal pain (13%), musculoskeletal chest pain (11%)
• Common (1% to 10%): Muscular weakness, neck pain, myalgia, peripheral swelling
• Uncommon (0.1% to 1%): Joint swelling
• Rare (less than 0.1%): Rhabdomyolysis
• Frequency not reported: Femur fracture, cervical vertebral fracture, femoral neck fracture, fractured pelvis, hip fracture, rib fracture, spinal cord compression, spinal compression fracture, connective tissue pain/discomfort, arthritis, gouty arthritis, chondrocalcinosis pyrophosphate^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (28%), depression (11%), anxiety (10%)
• Common (1% to 10%): Mood swings, hallucination, loss of libido, erectile dysfunction, confusional state, altered mood^[Ref]

Nervous system

• Very common (10% or more): Dizziness (23%), tremor (21%), headache (20%), dysgeusia (15%), peripheral neuropathy (15%), paresthesia (13%), hypoesthesia (10.)
• Common (1% to 10%): Neuropathy, syncope, cerebrovascular accident, cerebral ischemia, ataxia, impaired balance, vertigo
• Uncommon (0.1% to 1%): Intracranial hemorrhage, transient ischemic attack
• Frequency not reported: Vertigo, aphasia, cerebellar infarction, cerebral infarction, depressed level of consciousness, dysarthria, migraine, subarachnoid hemorrhage^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (23%), decreased weight (20%), hypokalemia (17%), anorexia (16%), hypocalcemia (11%)
• Common (1% to 10%): Dehydration, gout, hypophosphatemia, hyponatremia, hypomagnesemia, increased c-reactive protein, iron overload
• Frequency not reported: Hypernatremia^[Ref]

Ocular

• Very common (10% or more): Blurred vision (17%), cataracts (14%)
• Common (1% to 10%): Subcapsular cataract, unilateral cataract, blindness, ocular hypertension, reduced visual acuity^[Ref]

Hepatic

• Very common (10% or more): Hyperbilirubinemia (15%)
• Common (1% to 10%): Increased ALT, increased AST, abnormal liver function tests
• Frequency not reported: Cholecystitis, hepatic failure, kidney infection
• Postmarketing reports: Toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, mixed cytolytic/cholestatic hepatitis, cholestasis^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (14%)
• Common (1% to 10%): Dysuria, hyperuricemia, hematuria, urinary retention, urinary incontinence
• Frequency not reported: Urosepsis^[Ref]

Endocrine

• Very common (10% or more): Hyperglycemia (12%)
• Common (1% to 10%): Diabetes mellitus, acquired hypothyroidism
• Frequency not reported: Basedow's disease, hypoglycemia
• Postmarketing reports: Hypothyroidism, hyperthyroidism^[Ref]

Cardiovascular

• Very common (10% or more): Deep vein thrombosis (10%)
• Common (1% to 10%): Hypertension, hypotension, atrial fibrillation, myocardial infarction, tachycardia, congestive cardiac failure, bradycardia, hematoma, angina pectoris, palpitations, vasculitis
• Uncommon (0.1% to 1%): Arrhythmia, QT prolongation, atrial flutter, ventricular extrasystoles, ischemia, peripheral ischemia, intracranial venous sinus thrombosis
• Frequency not reported: Supraventricular tachycardia/arrhythmia, cardiac arrest, cardio-respiratory arrest, cardiomyopathy, myocardial ischemia, cardiac failure, cardiogenic shock, ventricular dysfunction, increased troponin, aortic disorder, ischemia, superficial thrombophlebitis, thrombosis^[Ref]

Oncologic

• Very common (10% or more): Tumor flare (10%)
• Common (1% to 10%): Squamous cell carcinoma, basal cell carcinoma, myelodysplastic syndrome
• Frequency not reported: Acute leukemia, acute myeloid leukemia, bronchoalveolar carcinoma, metastatic lung cancer, lymphoma, metastatic prostate cancer, tumor lysis syndrome^[Ref]

Renal

• Very common (10% or more): Renal failure (10%)
• Uncommon (0.1% to 1%): Renal tubular necrosis, acquired Fanconi syndrome
• Frequency not reported: Increased blood creatinine, azotemia, ureteric calculus, renal mass^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity
• Postmarketing reports: Angioedema, acute graft-versus-host disease (following allogeneic hematopoietic transplant)^[Ref]

Frequently asked questions

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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.

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