Note: This document contains side effect information about lenalidomide. Some dosage forms listed on this page may not apply to the brand name Revlimid.
Summary
Common side effects of Revlimid include: pneumonia, upper respiratory tract infection, urinary tract infection, neutropenia, thrombocytopenia, abdominal pain, anemia, arthralgia, asthenia, back pain, constipation, cough, diarrhea, dizziness, dyspnea, dyspnea on exertion, edema, epistaxis, fatigue, headache, hypokalemia, insomnia, limb pain, muscle cramps, nasopharyngitis, nausea, peripheral edema, pharyngitis, pruritus, skin rash, vomiting, anorexia, and xeroderma. Other side effects include: febrile neutropenia, cellulitis, chest pain, depression, dysuria, hypertension, hypoesthesia, hypomagnesemia, hypothyroidism, increased serum alanine aminotransferase, leukopenia, loose stools, myalgia, night sweats, pain, palpitations, peripheral neuropathy, rhinitis, upper abdominal pain, bruise, diaphoresis, dysgeusia, ecchymoses, erythema of skin, and xerostomia. Continue reading for a comprehensive list of adverse effects.
Applies to lenalidomide: oral capsules.
Warning
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Teratogenic Effects
- Potential risk of teratogenicity and fetotoxicity due to structural similarity to thalidomide, a known human teratogen that can cause severe, life-threatening birth defects if administered during pregnancy.1 7 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
- Contraindicated in pregnant women.1
- In females of reproductive potential, pregnancy must be excluded prior to treatment initiation with 2 negative pregnancy tests, and pregnancy must be prevented by abstinence or simultaneous use of 2 forms of reliable contraception.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
- Available only through a restricted distribution program.1 43 (See REMS under Dosage and Administration.)
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Hematologic Toxicity
- Risk of severe thrombocytopenia and neutropenia.1 16 (See Hematologic Effects under Cautions.)
- Monitor CBCs periodically.1 Dosage interruption and/or reduction may be required.1
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Thromboembolic Effects
- Increased risk of venous thromboembolism (e.g., DVT, PE) or arterial thromboembolism (e.g., MI, stroke).1
- Monitor for signs and symptoms of thromboembolism.1 7
- Thromboprophylaxis is recommended.1 (See Thromboembolic Events under Cautions.)
REMS:
FDA approved a REMS for lenalidomide to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of lenalidomide and consists of the following: elements to assure safe use and implementation system. See the FDA REMS page ([Web]).
Side effects include:
Multiple myeloma (≥20%): Diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, tremor.
MDS (>15%): Thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, epistaxis.
Mantle cell lymphoma, follicular lymphoma, or marginal-zone lymphoma (≥15%): Neutropenia, thrombocytopenia, anemia, leukopenia, diarrhea, constipation, nausea, fatigue, pyrexia, cough, upper respiratory tract infection, rash.
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]
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]
