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Home > Drugs > BCR-ABL tyrosine kinase inhibitors > Gleevec > Gleevec Side Effects
BCR-ABL tyrosine kinase inhibitors

Gleevec Side Effects

Note: This document contains side effect information about imatinib. Some dosage forms listed on this page may not apply to the brand name Gleevec.

Applies to imatinib: oral tablets.

Side effects include:

Adverse effects reported in ≥30% of patients were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.

For Healthcare Professionals

Applies to imatinib: oral capsule, oral tablet.

Cardiovascular

Uncommon (0.1% to 1%): Cerebral hemorrhage, palpitations, tachycardia, congestive heart failure, pulmonary edema, hypertension, peripheral coldness, hypotension, Raynaud's phenomenon, chest pain

Rare (less than 0.1%): Increased intracranial pressure, arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion

Frequency not reported: Cerebral edema, pericarditis, cardiac tamponade[Ref]

Dermatologic

Very common (10% or more): Dermatitis/eczema/rash (40%)

Common (1% to 10%): Flushing, pruritus, face edema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction

Uncommon (0.1% to 1%): Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions

Rare (less than 0.1%): Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discoloration, angioneurotic edema, rash vesicular, erythema multiforme, leukocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis (AGEP)

Frequency not reported: Palmoplantar erythrodysesthesia syndrome, lichenoid keratosis, lichen planus, toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (50%), diarrhea (45%), abdominal pain (37%), constipation (11%), vomiting, dyspepsia

Common (1% to 10%): Flatulence, abdominal distension, gastroesophageal reflux, dry mouth, gastritis

Uncommon (0.1% to 1%): Gastroenteritis, stomatitis, mouth ulceration, gastrointestinal hemorrhage, eructation, melena, esophagitis, ascites, gastric ulcer, hematemesis, cheilitis, dysphagia, pancreatitis

Rare (less than 0.1%): Colitis, ileus, inflammatory bowel disease

Frequency not reported: Ileus/intestinal obstruction, gastrointestinal perforation, diverticulitis, gastric antral vascular ectasia (GAVE)[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection, gynecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal edema

Rare (less than 0.1%): Hemorrhagic corpus luteum/hemorrhagic ovarian cyst[Ref]

Hematologic

Very common (10% or more): Hemorrhage (29%), neutropenia, thrombocytopenia, anemia

Common (1% to 10%): Pancytopenia, febrile neutropenia, hemorrhage

Uncommon (0.1% to 1%): Thrombocythemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy, hematoma, subdural hematoma

Rare (less than 0.1%): Hemolytic anemia

Frequency not reported: Thrombosis/embolism[Ref]

Hepatic

Common (1% to 10%): Increased hepatic enzymes

Uncommon (0.1% to 1%): Hyperbilirubinemia, hepatitis, jaundice

Rare (less than 0.1%): Hepatic failure, hepatic necrosis[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic shock[Ref]

Immunologic

Very common (10% or more): Influenza (14%)

Uncommon (0.1% to 1%): Herpes zoster, herpes simplex, cellulitis, sepsis

Rare (less than 0.1%): Fungal infection

Frequency not reported: Hepatitis B reactivation[Ref]

Metabolic

Very common (10% or more): Weight gain (16%)

Common (1% to 10%): Anorexia, weight loss

Uncommon (0.1% to 1%): Hypokalemia, increased appetite, hypophosphatemia, dehydration, gout, hyperuricemia, hypercalcemia, hyperglycemia, hyponatremia, blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased

Rare (less than 0.1%): Hyperkalemia, hypomagnesemia, blood amylase increased[Ref]

Musculoskeletal

Very common (10% or more): Muscle spasm/cramps (49%), musculoskeletal pain (47%), joint pain (31%), myalgia (24%), bone pain (11%)

Common (1% to 10%): Joint swelling

Uncommon (0.1% to 1%): Joint and muscle stiffness

Rare (less than 0.1%): Muscular weakness, arthritis, rhabdomyolysis/myopathy

Frequency not reported: Avascular necrosis/hip necrosis, growth retardation in children[Ref]

Nervous system

Very common (10% or more): Headache (37%), dizziness (19%)

Common (1% to 10%): Paresthesia, hypoesthesia

Uncommon (0.1% to 1%): Migraine, syncope, peripheral neuropathy, sciatica, restless leg syndrome, tremor, vertigo

Rare (less than 0.1%): Seizures[Ref]

Ocular

Very common (10% or more): Periorbital edema

Common (1% to 10%): Eyelid edema, lacrimation increased, conjunctival hemorrhage, conjunctivitis, dry eye, blurred vision

Uncommon (0.1% to 1%): Eye irritation, eye pain, orbital edema, scleral hemorrhage, retinal hemorrhage, blepharitis, macular edema

Rare (less than 0.1%): Optic neuritis, cataract, glaucoma, papilledema

Frequency not reported: Vitreous hemorrhage[Ref]

Oncologic

Rare (less than 0.1%): Tumor lysis syndrome

Frequency not reported: Tumor hemorrhage, tumor necrosis[Ref]

Other

Very common (10% or more): Fluid retention/edema (62%, fatigue (39%), pyrexia (18%)

Common (1% to 10%): Taste disturbance, weakness, pyrexia, anasarca, chills, rigors

Uncommon (0.1% to 1%): Tinnitus, hearing loss, malaise[Ref]

Psychiatric

Very common (10% or more): Insomnia (15%), depression (15%)

Uncommon (0.1% to 1%): Anxiety, somnolence, memory impairment

Rare (less than 0.1%): Confusional state[Ref]

Renal

Uncommon (0.1% to 1%): Renal pain, hematuria, renal failure acute, urinary frequency increased

Frequency not reported: Chronic renal failure[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (31%), cough (20%), upper respiratory tract infection (20%), pharyngolaryngeal pain (18%), sinusitis (11%)

Common (1% to 10%): Dyspnea, epistaxis

Uncommon (0.1% to 1%): Pneumonia, pleural effusion, pharyngitis

Rare (less than 0.1%): Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary hemorrhage

Frequency not reported: Acute respiratory failure, interstitial lung disease[Ref]

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