Phyrago Side Effects

Generic name: dasatinib

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

Applies to dasatinib: oral tablet.

Serious side effects of Phyrago

Along with its needed effects, dasatinib (the active ingredient contained in Phyrago) 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 dasatinib:

More common

• bleeding gums
• bloody or black, tarry stools
• body aches or pain
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chest pain or tightness
• chills
• constipation
• cough
• coughing up blood
• decrease in the amount of urine
• dizziness
• ear congestion
• fainting
• fast, slow, or irregular heartbeat
• fever
• full or bloated feeling
• headache
• hoarseness
• increased menstrual flow or vaginal bleeding
• loss of voice
• lower back or side pain
• noisy or rattling breathing
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pressure in the stomach
• prolonged bleeding from cuts
• red or dark brown urine
• runny or stuffy nose
• sensation of pins and needles
• severe stomach pain
• sneezing
• sore throat
• stabbing pain
• swelling of the stomach area
• swelling of the face, fingers, hands, feet, or lower legs
• trouble 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

Less common

• blue lips and fingernails
• chest discomfort
• coughing that sometimes produces a pink frothy sputum
• difficult or fast breathing
• dilated neck veins
• increased sweating
• irregular breathing
• loss of appetite
• nausea
• stomach pain, severe
• swelling in the legs and ankles
• vomiting
• yellow eyes or skin

Incidence not known

• anxiety
• blistering, peeling, or loosening of the skin
• blurred vision
• cloudy or bloody urine
• diarrhea
• itching
• joint or muscle pain
• nervousness
• pain, redness, or swelling in the arm or leg
• pounding in the ears
• red skin lesions, often with a purple center
• red, irritated eyes
• sudden weakness in the arms or legs
• sudden, severe chest pain
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Other side effects of Phyrago

Some side effects of dasatinib 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

• bone pain
• cracked lips
• difficulty with moving
• difficulty with swallowing
• lack or loss of strength
• loss of appetite
• muscle aching, cramping, or stiffness
• pain
• skin rash
• stomach pain
• swollen joints
• vomiting
• weight loss

For Healthcare Professionals

Applies to dasatinib: oral tablet.

General

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

Hematologic

• 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]

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]

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

• 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]

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]

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]

Frequently asked questions

• Is Sprycel a chemotherapy drug?
• How long does it take Sprycel (dasatinib) to start working?

Further information

Phyrago 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