Lenalidomide Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 7, 2023.

Applies to lenalidomide: oral capsule.

Warning

Oral route (Capsule)

Embryo-Fetal Toxicity, Hematologic Toxicity, and Venous and Arterial ThromboembolismEmbryo-Fetal ToxicityDo 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 ThromboembolismLenalidomide 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

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

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

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

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]