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Revlimid Side Effects

Generic Name: lenalidomide

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.

In 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, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lenalidomide: oral capsule

Along with its needed effects, lenalidomide (the active ingredient contained in Revlimid) 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
  • 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
  • tightness in the chest
  • 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
  • extreme tiredness or weakness
  • 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
  • dizziness or lightheadedness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • general feeling of tiredness or weakness
  • hair loss
  • hoarseness or husky voice
  • itching or rash
  • 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
  • troubled breathing
  • unpleasant breath odor
  • vomiting of blood
  • weight loss
  • yellow eyes or skin

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
  • bruising
  • 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
  • trouble swallowing
  • 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 (72.3%), anemia (43.8%), leukopenia (31.7%), lymphopenia (17.9%), neutropenic infection (17.9%), febrile neutropenia (17.4%)
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 (54.5%), constipation (40.5%), nausea (26.1%), gastroenteritis (22.5%), abdominal pain (20.5%), vomiting (12.2%), dyspepsia (10.7%)
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 (47.4%), nasopharyngitis (34.8%), cough (28%), upper respiratory tract infection (26.8%), dyspnea (23.5%), pneumonia (17.5%), pharyngitis (15.5%), rhinitis (15%), epistaxis (14.9%), 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 (43.9%), asthenia (29.7%), pyrexia (27.5%), peripheral edema (26.3%), influenza (13.3%), edema (10.1%)
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 (41.9%), rash (35.8%), dry skin (14.2%), hyperhidrosis (10.2%)
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 (33.4%), muscle spasms (33.4%), back pain (32%), arthralgia (21.6%), bone pain (16.4%), pain in extremity (14.8%), musculoskeletal pain (12.6%), musculoskeletal chest pain (11.3%)
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 (27.6%), depression (10.9%), anxiety (10.2%)
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 (23.2%), tremor (21.2%), headache (19.6%), dysgeusia (15.3%), peripheral neuropathy (15.2%), paresthesia (13.3%), hypoesthesia (10.2%)
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 (23.1%), decreased weight (19.5%), hypokalemia (17.1%), anorexia (15.6%), hypocalcemia (10.7%)
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 (17.3%), cataracts (13.7%)
Common (1% to 10%): Subcapsular cataract, unilateral cataract, blindness, ocular hypertension, reduced visual acuity[Ref]

Hepatic

Very common (10% or more): Hyperbilirubinemia (15.2%)
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 (14.3%)
Common (1% to 10%): Dysuria, hyperuricemia, hematuria, urinary retention, urinary incontinence
Frequency not reported: Urosepsis[Ref]

Endocrine

Very common (10% or more): Hyperglycemia (11.7%)
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 (10.3%)
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. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Revlimid (lenalidomide)." Celgene Corporation, Summit, NJ.

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

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