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Revlimid Side Effects

Generic name: lenalidomide

Medically reviewed by Drugs.com. Last updated on Jan 25, 2022.

Note: This document contains side effect information about lenalidomide. Some of the 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lenalidomide: oral capsules

Warning

    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.)

    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

    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]

References

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

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.