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Imatinib Side Effects

For the Consumer

Applies to imatinib: oral capsule, oral tablet

Along with its needed effects, imatinib 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 imatinib:

More Common

  • Abdominal or stomach pain, cramping, burning, or tenderness
  • bleeding from wound after surgery
  • bleeding gums
  • bleeding problems
  • bloating or swelling of the face, hands, lower legs, or feet
  • blood in the urine
  • bloody eye
  • bloody nose
  • blue lips and fingernails
  • blurred vision
  • body aches or pain
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • coughing up blood
  • decrease in the amount of urine
  • decreased appetite
  • decreased urination
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • inability to speak
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • irregular heartbeat
  • itching or skin rash
  • joint pain
  • large, flat, blue, or purplish patches on the skin
  • loss of appetite
  • loss of voice
  • mood changes
  • muscle aches and pain
  • muscle cramps
  • nausea and vomiting
  • noisy, rattling breathing
  • nosebleed
  • numbness or tingling in the hands, feet, or lips
  • pain or tenderness around the eyes and cheekbones
  • painful or difficult urination
  • pale skin
  • prolonged bleeding from cuts
  • rapid weight gain
  • red, black, bloody, or tarry stools
  • red or dark brown urine
  • redness of the eye
  • seizures
  • shivering
  • slurred speech
  • small red or purple spots on the skin
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • sweating
  • swelling in the legs and ankles
  • swollen glands
  • temporary blindness
  • tightness in the chest
  • trouble sleeping
  • troubled breathing at rest
  • troubled breathing when moving or walking
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arm or leg on one side of the body, sudden and severe
  • yellow eyes or skin

Incidence Not Known

  • Anxiety
  • blistering, peeling, or loosening of the skin
  • change in vision not present before treatment
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • confusion
  • delayed or slow growth in children
  • irregular, fast or slow, or shallow breathing
  • nausea, heartburn, or indigestion, severe and continuing
  • pain in the bones
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • seeing floaters, veil, or curtain appearing across part of vision
  • severe abdominal or stomach pain, cramping, or burning
  • severe constipation
  • severe vomiting
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

Some side effects of imatinib 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

  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discouragement
  • excess air or gas in the stomach or intestines
  • fear or nervousness
  • feeling sad or empty
  • feeling unusually cold
  • full or bloated feeling
  • increased bowel movements
  • irritability
  • lack or loss of strength
  • loose stools
  • loss of interest or pleasure
  • muscle stiffness
  • night sweats
  • passing gas
  • stomach discomfort, upset, or pain
  • swollen joints
  • trouble concentrating
  • weight loss

Less Common

  • Back pain
  • bad, unusual, or unpleasant (after) taste
  • change in taste
  • watering of the eyes

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 and 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): Fatigue (39%), pyrexia (18%), fluid retention/edema

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Gleevec (imatinib mesylate)." Novartis Pharmaceuticals, East Hanover, NJ.

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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