Dasatinib Side Effects

Not all side effects for dasatinib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dasatinib: oral tablet

In addition to its needed effects, some unwanted effects may be caused by dasatinib. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking dasatinib:

More common
  • Bloody or black, tarry stools
  • body aches or pain
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chest pain
  • constipation
  • cough or hoarseness
  • coughing up blood
  • decrease in the amount of urine
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fainting
  • fast, slow, or irregular heartbeat
  • fever or chills
  • full or bloated feeling
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • noisy or rattling breathing
  • painful or difficult urination
  • pale skin
  • paralysis
  • pressure in the stomach
  • runny nose
  • sensation of pins and needles
  • severe stomach pain
  • shortness of breath
  • sneezing
  • sore throat
  • stabbing pain
  • swelling of the abdominal or stomach area
  • swelling of the face, fingers, hands, feet, or lower legs
  • tightness in the chest
  • troubled breathing
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arms, hands, legs, or feet
  • weight gain
  • wheezing
Less common
  • Bloating
  • blue lips and fingernails
  • chest discomfort
  • coughing that sometimes produces a pink frothy sputum
  • decreased urine output
  • difficult or fast breathing
  • dilated neck veins
  • increased sweating
  • irregular breathing
  • irregular heartbeat
  • nausea
  • swelling
  • swelling in the legs and ankles
Incidence not known
  • Anxiety
  • pain, redness, or swelling in the arm or leg
  • sudden shortness of breath or troubled breathing
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Some of the side effects that can occur with dasatinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • bleeding gums
  • cracked lips
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • increased menstrual flow or vaginal bleeding
  • itching skin
  • lack or loss of strength
  • loss of appetite
  • muscle aching or cramping
  • muscle or bone pain
  • muscle stiffness
  • nose bleeds
  • pain
  • pain in the joints
  • prolonged bleeding from cuts
  • red or dark brown urine
  • skin rash
  • swelling or inflammation of the mouth
  • swollen joints
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to dasatinib: oral tablet

Hematologic

In the phase III dose optimization study in patients with chronic phase CML, grade 3 or 4 myelosuppression occurred more frequently in patients treated with the 70 mg twice daily regimen than in those treated with a 100 mg once daily regimen.

Very common (10% or more): Hemorrhage (11 to 26%)
Common (1% to 10%): Febrile neutropenia, pancytopenia
Uncommon (0.1% to 1%): CNS bleeding
Rare (Less than 0.1%): Aplasia pure red cell

General

The most common side effects included fluid retention, musculoskeletal pain, diarrhea, rash, and headache.

Gastrointestinal

Very common (10% or more): Diarrhea (18 to 31%), vomiting (11 to 16%), nausea (18 to 24%), abdominal pain (12%)
Common (1% to 10%): Enterocolitis infection, gastrointestinal bleeding, neutropenic colitis, gastritis, mucositis, stomatitis, dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Uncommon (0.1% to 1%): Pancreatitis, upper gastrointestinal ulcer, esophagitis, ascites, anal fissure, dysphagia
Rare (Less than 0.1%): Protein-losing gastroenteropathy, ileus
Postmarketing reports: Fatal gastrointestinal hemorrhage

Nervous system

Very common (10% or more): Headache (13 to 33%)
Common (1% to 10%): Neuropathy, peripheral neuropathy, dizziness, dysgeusia, somnolence
Uncommon (0.1% to 1%): Syncope, amnesia, tremor
Rare (Less than 0.1%): Cerebrovascular accident, transient ischemic attack, convulsion, optic neuritis, seventh nerve paralysis

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (11 to 22%)
Common (1% to 10%): Arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm, chills
Uncommon (0.1% to 1%): Rhabdomyolysis, muscle inflammation, tendonitis, blood creatine phosphokinase increased

Respiratory

Very common (10% or more): Pleural effusion (11 to 24%), dyspnea (15 to 24%), cough
Common (1% to 10%): Pneumonia (including bacterial, viral, fungal), upper respiratory tract infection, pulmonary edema, pulmonary hypertension, lung infiltration, pneumonitis
Uncommon (0.1% to 1%): Bronchospasm, asthma
Rare (Less than 0.1%): Acute respiratory distress syndrome
Postmarketing reports: Pulmonary embolism, interstitial lung disease, pulmonary arterial hypertension

Metabolic

Common (1% to 10%): Anorexia, appetite disturbances, hyperuricemia, weight decreased, weight increased
Uncommon (0.1% to 1%): Hypoalbuminemia

Hepatic

Uncommon (0.1% to 1%): Hepatitis, cholecystitis, cholestasis

Cardiovascular

Common (1% to 10%): Congestive heart failure, cardiac dysfunction, pericardial effusion, arrhythmia, tachycardia, palpitations, hypertension, chest pain
Uncommon (0.1% to 1%): Myocardial infarction, electrocardiogram QT prolongation, pericarditis, ventricular arrhythmia, ventricular tachycardia, angina pectoris, cardiomegaly, hypotension
Rare (less than 0.1%): Cor pulmonale, myocarditis, acute coronary syndrome
Postmarketing reports: Atrial fibrillation, atrial flutter

Results from phase II single arm clinical studies of 911 patients reported QT prolongation in 9 patients. Three patients (less than 1%) experienced a QTcF greater than 500 milliseconds.

In the phase III dose optimization study in patients with chronic phase CML, pleural effusion and congestive cardiac failure/cardiac dysfunction occurred more frequently in the 70 mg twice a day regimen than in those treated with a 100 mg once daily regimen.

Dermatologic

Very common (10% or more): Skin rash (15 to 21%)
Common (1% to 10%): Flushing, alopecia, dermatitis, eczema, pruritus, acne, dry skin, urticaria, hyperhidrosis, contusion
Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome
Rare (Less than 0.1%): Livedo reticularis

Renal

Very common (10% or more): Fluid retention (21 to 42%)
Uncommon (0.1% to 1%): Renal failure, urinary frequency, proteinuria

Other

Very common (10% or more): Fatigue (19 to 26%), superficial edema (10 to 21%), pyrexia (11 to 18%)
Common (1% to 10%): Tinnitus, pain, generalized edema, asthenia
Uncommon (0.1% to 10%): Vertigo, thrombophlebitis, gynecomastia, irregular menstruation, malaise, temperature intolerance
Postmarketing reports: Deep vein thrombosis

Psychiatric

Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Anxiety, confusion, affect lability, libido decreased

Hypersensitivity

Uncommon (0.1% to 1%): Erythema nodosum, unspecified hypersensitivity reaction

Ocular

Common (1% to 10%): Visual disturbance, blurred vision, reduction in visual acuity, dry eye
Uncommon (0.1% to 1%): Conjunctivitis
Rare (Less than 0.1%): Visual impairment

Oncologic

Uncommon (0.1% to 1%): Tumor lysis syndrome

Immunologic

Very common (10% or more): Infection (including bacterial, viral, fungal, non-specified) (10 to 14%)
Common (1% to 10%): Sepsis

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