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

Summary

Common side effects of Sprycel include: pericardial effusion, pleural effusion, pulmonary edema, dyspnea, fluid retention, and gastrointestinal hemorrhage. Other side effects include: anasarca. Continue reading for a comprehensive list of adverse effects.

Applies to dasatinib: oral tablets.

Side effects include:

Adverse effects reported in 15% or more of patients receiving dasatinib (the active ingredient contained in Sprycel) as monotherapy myelosuppression, fluid retention, diarrhea, headache, rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

Adverse effects reported in 30% or more of pediatric patients receiving dasatinib in combination with chemotherapy include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infection, hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

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.^[Ref]

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^[Ref]

General

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

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

Metabolic

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

Uncommon (0.1% to 1%): Hypoalbuminemia^[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatitis, cholecystitis, cholestasis^[Ref]

Cardiovascular

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.^[Ref]

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^[Ref]

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^[Ref]

Renal

Very common (10% or more): Fluid retention (21 to 42%)

Uncommon (0.1% to 1%): Renal failure, urinary frequency, proteinuria^[Ref]

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^[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia

Uncommon (0.1% to 1%): Anxiety, confusion, affect lability, libido decreased^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Erythema nodosum, unspecified hypersensitivity reaction^[Ref]

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^[Ref]

Oncologic

Uncommon (0.1% to 1%): Tumor lysis syndrome^[Ref]

Immunologic

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

Common (1% to 10%): Sepsis^[Ref]