Sprycel Side Effects

Generic name: dasatinib

Medically reviewed by Drugs.com. Last updated on Sep 28, 2023.

Note: This document provides detailed information about Sprycel.

Applies to dasatinib: oral tablet Side Effects associated with dasatinib. Some dosage forms listed on this page may not apply specifically to the brand name Sprycel.

Applies to dasatinib: oral tablet.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

Using this medicine while you are pregnant can harm your unborn baby. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 30 days after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 30 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Dasatinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Dasatinib may cause fluid retention, including pleural effusion (fluid build-up around your lungs). Check with your doctor right away if you have a decrease in the amount of urine, noisy or rattling breathing, difficulty breathing, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain.

This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Check with your doctor right away if you have any symptoms of heart rhythm problems, including a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have chest discomfort or pain, decreased urine output, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble breathing, or unusual tiredness or weakness. These could be symptoms of a serious heart or blood vessel problem (eg, heart attack, stroke).

Using this medicine may cause headache, muscle or joint pain, skin rash, or unusual tiredness or weakness. If these symptoms persist and become worse, check with your doctor.

This medicine may increase your risk of having a condition called pulmonary arterial hypertension (high blood pressure in the lungs). This may occur at anytime during treatment with this medicine. Check with your doctor right away if you have trouble breathing, tiredness, or swelling all over your body (fluid retention).

Serious skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

This medicine may cause slowed growth and development in children. Your child's doctor may want to monitor their weight and growth regularly. Talk to your child's doctor if you have concerns.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, loss of appetite, nausea or vomiting, stomach pain, sever, or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Sprycel

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

Other side effects of Sprycel

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:

For healthcare professionals

Applies to dasatinib: oral tablet.

General adverse events

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]

See also:

Frequently asked questions

• Gleevec vs Sprycel vs Tasigna - how do they compare?
• Is Sprycel a chemotherapy drug?
• How long does it take Sprycel (dasatinib) to start working?

Further information

Sprycel 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer