Dasatinib Side Effects

Some side effects of dasatinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dasatinib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking dasatinib: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking dasatinib and call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

• feeling tired or short of breath (even with mild exertion);

• swelling in your feet or lower legs;

• rapid weight gain;

• blue-colored lips and skin; and

• a light-headed feeling, like you might pass out.

Stop using dasatinib and call your doctor at once if you have any of these other side effects:

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down); or

• pain in your chest, on your left side, or behind your breastbone.

Common side effects may include:

• headache;

• joint or muscle pain;

• nausea, diarrhea; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dasatinib: oral tablet

Hematologic

Hematologic side effects including neutropenia (up to 83%), thrombocytopenia (up to 83%), anemia (up to 70%), hemorrhage (40%), and febrile neutropenia (9%) have been reported. Pancytopenia has been reported frequently. Coagulopathy and pure red cell aplasia have been reported infrequently.

General

General side effects including pyrexia (39%), fatigue (39%), pain (26%) and abdominal pain (25%), asthenia (19%), mucosal inflammation (16%), dizziness (14%), decreased weight (14%), chest pain (13%), abdominal distention (11%), increased weight (11%), and chills (11%) have been reported. Malaise has been reported frequently. Temperature intolerance has been reported infrequently. Fluid retention (50%) has included superficial edema (36%), pleural effusion (22%), other fluid retention (14%), generalized edema (5%), and ascites (1%).

Gastrointestinal

Gastrointestinal side effects including diarrhea (49%), nausea (34%), vomiting (22%), anorexia (19%), gastrointestinal bleeding (14%), and constipation (14%) have been reported. Dyspepsia, oral soft tissue disorder, gastritis, colitis, anal fissure, and dysphagia have been reported frequently. Esophagitis, upper gastrointestinal ulcer, ileus, and pancreatitis have been reported infrequently. . Severe gastrointestinal hemorrhage (4%), including fatalities, was reported and generally required treatment interruption and transfusion.

Nervous system

Nervous system side effects including headache (40%), neuropathy (including peripheral neuropathy) (13%), and CNS bleeding (2%) have been reported. Dysgeusia, somnolence, syncope, tremor, and convulsions have been reported frequently. Amnesia, cerebrovascular accident, transient ischemic attack, and reversible posterior leukoencephalopathy syndrome have been reported infrequently.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain (39%), arthralgia (19%), and myalgia (12%) have been reported. Muscle inflammation, muscular weakness, and musculoskeletal stiffness have been reported frequently. Tendonitis and rhabdomyolysis have been reported infrequently.

Respiratory

Respiratory side effects have included dyspnea (32%), cough (28%), upper respiratory tract infection/inflammation (26%), bacterial, viral, and fungal pneumonia (11%), pulmonary edema (4%), and pulmonary hypertension (1%). Lung infiltration, pneumonitis, and asthma have been reported frequently. Bronchospasm and acute respiratory distress syndrome have been reported infrequently.

Metabolic

Metabolic side effects including hypophosphatemia (up to 23%) and hypocalcemia (up to 20%) have been reported. Appetite disturbances and hyperuricemia have been reported frequently. Hypoalbuminemia has been reported infrequently.

Hepatic

Hepatic side effects including elevated SGPT (ALT) (up to 11%), elevated SGOT (AST) (up to 8%), elevated bilirubin (up to 8%), and elevated transaminase have been reported. Cholecystitis, cholestasis, and hepatitis have been reported infrequently.

Cardiovascular

Cardiovascular side effects including arrhythmia (11%) and pericardial effusion (4%) have been reported. Palpitations, flushing, hypotension, hypertension, angina pectoris, cardiomegaly, and myocardial infarction have been reported frequently. Pericarditis, ventricular tachycardia, acute coronary syndrome, myocarditis, and QT prolongation have been reported infrequently. Congestive heart failure/cardiac dysfunction (4%) has included ventricular dysfunction, cardiac failure, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, ejection fraction decreased, and left ventricular failure.

Dermatologic

Dermatologic side effects including pruritus (11%) have been reported. Hyperhidrosis, alopecia, dry skin, acne, urticaria, dermatitis (including eczema), photosensitivity reaction, nail disorder, and pigmentation disorder have been reported frequently. Skin ulcer, acute febrile neutrophilic dermatosis, bullous conditions, livedo reticularis, panniculitis, palmar-plantar erythrodysesthesia syndrome have been reported infrequently. Skin rash (35%) has included erythema, exfoliative rash, generalized erythema, milia, rash, erythematous rash, follicular rash, generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, skin exfoliation, systemic lupus erythematosus rash, vesiculosa urticaria, drug eruption, and vesicular rash.

Renal

Renal side effects including elevated creatinine (up to 2%) have been reported. Urinary frequency and renal failure have been reported frequently. Proteinuria has been reported infrequently.

Other

Other side effects including infection (including bacterial, viral, fungal, non-specified), herpes virus infection, sepsis (including fatal outcomes), enterocolitis infection, tinnitus, vertigo, and contusion have been reported frequently. Blood creatine phosphokinase increased has also been reported.

Psychiatric

Psychiatric side effects including insomnia, depression, anxiety, confusional state, and affect lability have been reported frequently. Decreased libido has been reported infrequently.

Genitourinary

Genitourinary side effects including gynecomastia have been reported frequently. Irregular menstruation has been reported infrequently.

Hypersensitivity

Hypersensitivity side effects have infrequently included erythema nodosum.

Ocular

Ocular side effects including visual disorder, conjunctivitis, and dry eyes have been reported frequently.

Oncologic

Oncologic side effects including tumor lysis syndrome have been reported frequently.

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