Lenalidomide Side Effects

Brand Names: Revlimid

Please note - some side effects for Lenalidomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lenalidomide - for the Consumer

Lenalidomide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lenalidomide:

Back pain; constipation; cough; diarrhea; dizziness; dry mouth or skin; headache; increased sweating or night sweats; loss of appetite; nausea; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stools or vomit; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; muscle cramps; muscle or joint pain; pain, numbness, tingling, tenderness, or swelling of the arms or legs; painful or difficult urination; red, swollen, blistered, or peeling skin; severe tiredness or weakness; shortness of breath; stomach pain; unusual bruising or bleeding.

Side Effects by Body System

Hematologic

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%).

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

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

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, 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

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

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

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

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

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

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

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

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

Hepatic

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

Endocrine

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

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.

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

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

Oncologic

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

Ocular

Ocular side effects including blindness have been reported.

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