Imkeldi Side Effects

Generic name: imatinib

Note: This document provides detailed information about Imkeldi Side Effects associated with imatinib. Some dosage forms listed on this page may not apply specifically to the brand name Imkeldi.

Applies to imatinib: oral tablet.

Serious side effects of Imkeldi

Along with its needed effects, imatinib (the active ingredient contained in Imkeldi) 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 side effects

• 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

Other side effects of Imkeldi

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 side effects

• 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 side effects

• 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 adverse events

• 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]

Frequently asked questions

• What to avoid when taking Gleevec?
• Gleevec vs Sprycel vs Tasigna - how do they compare?
• Is there a generic for Gleevec?
• How does Gleevec (imatinib) work?
• Can I take Gleevec while pregnant?

Further information

Imkeldi side effects can vary depending on the individual. 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.

Medical Disclaimer