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.
Some side effects of Revlimid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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
- decreased urine
- difficult or labored breathing
- dry mouth
- 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
- blistering, peeling, or loosening of the skin
- clay-colored stools
- dark-colored urine
- depressed mood
- difficulty having a bowel movement (stool)
- dizziness or lightheadedness
- dry skin and hair
- fast heartbeat
- feeling cold
- general feeling of tiredness or weakness
- hair loss
- 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
- sudden shortness of breath or troubled breathing
- swelling of the feet or lower legs
- trouble sleeping
- unpleasant breath odor
- vomiting of blood
- weight gain or 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
- 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
- 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
- tender, swollen glands in the neck
- 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
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 (the active ingredient contained in Revlimid) 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%).
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.
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.
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.
Rashes have been characterized as morbilliform, urticarial, dermatitic, acneform, and undefined.
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.
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.
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.
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.
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.
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.
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.
Psychiatric side effects including insomnia (10.1%), depression (5.4%), mental status changes, delirium, delusion, psychotic disorder, and confusional state have been reported.
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.
Endocrine side effects have included acquired hypothyroidism (6.8%), adrenal insufficiency, and Basedow's disease.
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.
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.
Hypersensitivity side effects have included hypersensitivity (not otherwise specified).
Oncologic side effects including acute leukemia, acute myeloid leukemia, bronchoalveolar carcinoma, lung cancer metastatic, lymphoma, and metastatic prostate cancer have been reported.
Ocular side effects including blindness have been reported.
More about Revlimid (lenalidomide)
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