Revlimid Side Effects

Generic Name: lenalidomide

Note: This page contains side effects data for the generic drug lenalidomide. It is possible that some of the dosage forms included below may not apply to the brand name Revlimid.

It is possible that some side effects of Revlimid may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to lenalidomide: oral capsule

As well as its needed effects, lenalidomide (the active ingredient contained in Revlimid) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking lenalidomide, check with your doctor immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • convulsions
  • 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 or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • 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
Incidence not known
  • Anxiety
  • blistering, peeling, or loosening of the skin
  • clay-colored stools
  • dark-colored urine
  • depressed mood
  • diarrhea
  • difficulty having a bowel movement (stool)
  • dizziness or lightheadedness
  • dry skin and hair
  • fainting
  • fast heartbeat
  • feeling cold
  • general feeling of tiredness or weakness
  • hair loss
  • headache
  • hoarseness or husky voice
  • itching
  • 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
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • slowed heartbeat
  • stomach pain, continuing
  • sudden shortness of breath or troubled breathing
  • sweating
  • swelling of the feet or lower legs
  • trouble sleeping
  • unpleasant breath odor
  • vomiting of blood
  • weight gain or loss
  • yellow eyes or skin

Some lenalidomide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Abnormal or decreased touch sensation
  • bloody nose
  • blurred vision
  • body aches or pain
  • bruising
  • burning 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, stiffness, or twitching
  • pain or tenderness around the eyes and cheekbones
  • seizures
  • shivering
  • tender, swollen glands in the neck
  • trembling
  • trouble with concentrating
  • trouble with swallowing
  • unsteadiness or awkwardness
  • upper abdomen or stomach pain
  • voice changes
  • weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to lenalidomide: oral capsule

Hematologic

Hematologic side effects including thrombocytopenia (61.5%), neutropenia (58.8%), anemia (11.5%), leukopenia (8.1%), febrile neutropenia (5.4%), warm type hemolytic anemia, splenic infarction, bone marrow depression, coagulopathy, hemolysis, hemolytic anemia, pancytopenia, aggravated anemia, decreased hemoglobin, and refractory anemia have been reported.[Ref]

Thrombotic or thromboembolic events, including deep vein thrombosis, pulmonary embolism, thrombosis, and intracranial venous sinus thrombosis were reported more frequently in patients treated with the lenalidomide/dexamethasone combination. The number of patients experiencing a thrombotic event in the combination arm were 43/346 (12%) compared with those in the placebo/dexamethasone arm 14/345 (4%).[Ref]

Gastrointestinal

Gastrointestinal side effects including diarrhea (48.6%), constipation (23.6%), nausea (23.6%), abdominal pain (12.2%), vomiting (10.1%), upper abdominal pain (8.1%), dry mouth (6.8%), loose stools (6.1%), gastrointestinal hemorrhage, ischemic colitis, intestinal perforation, rectal hemorrhage, colonic polyp, diverticulitis, dysphagia, gastritis, gastroenteritis, gastroesophageal reflux disease, obstructive inguinal hernia, irritable bowel syndrome, melena, pancreatitis (due to biliary obstruction), pancreatitis (not otherwise specified), perirectal abscess, pseudomembranous colitis, peptic ulcer hemorrhage, oral infection, small intestinal obstruction, and upper gastrointestinal hemorrhage have been reported.[Ref]

Dermatologic

Rashes have been characterized as morbilliform, urticarial, dermatitic, acneform, and undefined.[Ref]

Dermatologic side effects including pruritus (41.9%), rash (35.8%), dry skin (14.2%), contusion (8.1%), night sweats (8.1%), increased sweating (6.8%), ecchymosis (5.4%), erythema (5.4%), skin desquamation, erythema multiforme, and acute febrile neutrophilic dermatosis have been reported. Twelve reports of Stevens-Johnson syndrome and one report of toxic epidermal necrolysis have also been reported.[Ref]

General

General side effects including fatigue (31.1%), pyrexia (20.9%), peripheral edema (20.3%), asthenia (14.9%), edema (10.1%), pain (6.8%), rigors (6.1%), chest pain (5.4%), disease progression, fall, abnormal gait, intermittent pyrexia, nodule, rigors, and sudden death have been reported.[Ref]

Respiratory

Respiratory side effects including nasopharyngitis (23.0%), cough (19.6%), dyspnea (16.9%), pharyngitis (15.5%), epistaxis (14.9%), upper respiratory tract infections (14,9%), pneumonia (11.5%), sinusitis (8.1%), exertional dyspnea (6.8%), rhinitis (6.8%), bronchitis (6.1%), acute sinusitis, exacerbated chronic obstructive airways disease, respiratory failure, exacerbated dyspnea, interstitial lung disease, lobar pneumonia, lung infiltration, wheezing, bronchopneumopathy, hypoxia, and sinusitis have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including arthralgia (21.6%), back pain (20.9%), muscle cramps (18.2%), limb pain (10.8%), myalgia (8.8%), peripheral swelling (8.1%), femur fracture, femoral neck fracture, fractured pelvis, hip fracture, rib fracture, arthritis, aggravated arthritis, gouty arthritis, neck pain, cervical vertebral fracture, chondrocalcinosis pyrophosphate, steroid myopathy, myopathy, and spinal compression fracture have been reported.[Ref]

Nervous system

Nervous system side effects including dizziness (19.6%), headache (19.6%), hypoesthesia (6.8%), dysgeusia (6.1%), peripheral neuropathy (5.4%), cerebrovascular accident, aphasia, cerebellar infarction, depressed level of consciousness, dysarthria, migraine, spinal cord compression, subarachnoid hemorrhage, transient ischemic attack, dizziness, memory impairment, brain edema, cerebral infarction, cerebral ischemia, cerebrovascular accident, encephalitis, intracranial hemorrhage, intracranial venous sinus thrombosis, leukoencephalopathy, somnolence, and tremor have been reported.[Ref]

Renal

Renal side effects have included urinary tract infection (10.8%), dysuria (6.8%), increased blood creatinine, renal failure, hematuria, acute renal failure, azotemia, ureteric calculus, renal mass, Fanconi syndrome, renal tubular necrosis, urinary retention, and kidney infection.[Ref]

Metabolic

Metabolic side effects including hypokalemia (10.8%), hypomagnesemia (6.1%), dehydration, gout, hypernatremia, diabetes mellitus, diabetes with hyperosmolarity, diabetic ketoacidosis, and hypoglycemia have been reported.[Ref]

Other

Other side effects have included anorexia (10.1%), cellulitis (5.4%), vertigo, infection, bacteremia, central line infection, clostridial infection, ear infection, Enterobacter sepsis, fungal infection, herpes viral infection, influenza, Klebsiella sepsis, localized infection, Pseudomonas infection, septic shock, Staphylococcal infection, urosepsis, transfusion reaction, post procedural hemorrhage, pelvic pain, and road traffic accident.[Ref]

Psychiatric

Psychiatric side effects including insomnia (10.1%), depression (5.4%), mental status changes, delirium, delusion, psychotic disorder, and confusional state have been reported.[Ref]

Hepatic

Hepatic side effects including increased alanine aminotransferase (8.1%), hyperbilirubinemia, acute cholecystitis, cholecystitis, toxic hepatitis, hepatic failure, intrahepatic cholestasis, and abnormal liver function tests have been reported. A case of severe hepatotoxicity has also been reported.[Ref]

Endocrine

Endocrine side effects have included acquired hypothyroidism (6.8%), adrenal insufficiency, and Basedow's disease.[Ref]

Cardiovascular

Cardiovascular side effects including hypertension (6.1%) palpitations (5.4%), congestive cardiac failure, atrial fibrillation, angina pectoris, cardiac arrest, thromboembolism, cardiac failure (not otherwise specified), cardiorespiratory arrest, atrial flutter, cardiomyopathy, myocardial infarction, myocardial ischemia, aggravated atrial fibrillation, bradycardia, cardiogenic shock, pulmonary edema, supraventricular arrhythmia, tachyarrhythmia, ventricular dysfunction, increased troponin I, deep vein thrombosis, hypotension, aortic disorder, ischemia, superficial thrombophlebitis, and thrombosis have been reported.[Ref]

One study has reported that treatment of multiple myeloma with lenalidomide and high-dose dexamethasone is associated with an increased risk of venous thrombosis and that concomitant administration of erythropoietic agents may further increase the risk of thrombosis.[Ref]

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity (not otherwise specified).[Ref]

Oncologic

Oncologic side effects including acute leukemia, acute myeloid leukemia, bronchoalveolar carcinoma, lung cancer metastatic, lymphoma, and metastatic prostate cancer have been reported.[Ref]

Ocular

Ocular side effects including blindness have been reported.[Ref]

References

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

2. Sviggum HP, Davis MD, Rajkumar SV, Dispenzieri A "Dermatologic adverse effects of lenalidomide therapy for amyloidosis and multiple myeloma." Arch Dermatol 142 (2006): 1298-302

3. Castaneda CP, Brandenburg NA, Bwire R, Burton GH, Zeldis JB "Erythema Multiforme/Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis in Lenalidomide-Treated Patients." J Clin Oncol (2008):

4. Hussain S, Browne R, Chen J, Parekh S "Lenalidomide-induced severe hepatotoxicity." Blood 110 (2007): 3814

5. Jena RK, Swain TR, Kansurkar SS, Swain M "Lenalidomide induced intrahepatic cholestasis in newly diagnosed patients of multiple myeloma." Eur J Clin Pharmacol (2011):

6. Bennett CL, Angelotta C, Yarnold PR, et al. "Thalidomide- and lenalidomide-associated thromboembolism among patients with cancer." JAMA 296 (2006): 2558-60

7. Knight R, DeLap RJ, Zeldis JB "Lenalidomide and venous thrombosis in multiple myeloma." N Engl J Med 354 (2006): 2079-80

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