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Bone Pain (9)
Acne (8)
Boils (6)
Pimples (6)
Plueral Effusion (5)
Arthritis (3)
Boils, Pimples (3)
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Sprycel Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1453 

Surgery (8402278-6)
on May 24, 2012 Female from UNITED STATES , 43 years of age, was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: surgery. Sprycel dosage: N/A.

Myocardial Infarction, Hypertension, Malaise, Incoherent (8398597-2)
Patient was taking Sprycel. Patient felt the following Sprycel side effects: myocardial infarction, hypertension, malaise, incoherent on May 22, 2012 from UNITED STATES Additional patient health information: Male , 74 years of age, . Sprycel dosage: N/A. Patient was hospitalized.

Fluid Retention, Pleural Effusion (8397445-4)
Adverse event was reported on May 29, 2012 by a Male taking Sprycel (Dosage: 100 Mg Daily Po) was diagnosed with
  • chronic myeloid leukaemia
and. Location: UNITED STATES , 39 years of age, After Sprycel was administered, patient encountered several Sprycel side effects: fluid retention, pleural effusion. Patient was hospitalized.

Pleural Effusion, Pulmonary Hypertension, Weight Increased, Fatigue, Oedema Peripheral, Abdominal Pain, Sleep Apnoea Syndrome (8394804-0)
on May 21, 2012 Male from SPAIN , 56 years of age, was diagnosed with
  • chronic myeloid leukaemia
and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: pleural effusion, pulmonary hypertension, weight increased, fatigue, oedema peripheral, abdominal pain, sleep apnoea syndrome. Sprycel dosage: N/A. Patient was hospitalized.


Accidental Overdose, Vomiting, Ataxia, Speech Disorder, Hemiparesis, Tremor (8393554-4)
on May 17, 2012 Female from UNITED KINGDOM , 40 years of age, was diagnosed with
  • chronic myeloid leukaemia
and was treated with Sprycel. Patient felt the following Sprycel side effects: accidental overdose, vomiting, ataxia, speech disorder, hemiparesis, tremor. Sprycel dosage: Also Taken 200mg In Sep2011 For 1 Month 100mg:apr2011-may2012.
Multiple prescriptions taken:
  • Venlafaxine Hcl
  • Ramipril
  • Omeprazole
  • Lantus


Blood Urea Abnormal, Blood Potassium Abnormal, Blood Creatinine Abnormal, Cardiac Failure, Atrioventricular Block Complete, Blood Uric Acid Abnormal (8390639-3)
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: blood urea abnormal, blood potassium abnormal, blood creatinine abnormal, cardiac failure, atrioventricular block complete, blood uric acid abnormal on May 17, 2012 from JAPAN Additional patient health information: Female , 95 years of age, weighting 74.96 lb, was diagnosed with
  • chronic myeloid leukaemia
and. Sprycel dosage: N/A. Patient was hospitalized.

Cognitive Disorder, Somnolence, Activities Of Daily Living Impaired, Mobility Decreased, Decreased Appetite, Lethargy, Depressed Level Of Consciousness (8390313-3)
Adverse event was reported on May 09, 2012 by a Female taking Sprycel (Dosage: 150 Mg;;po) was diagnosed with
  • glioblastoma multiforme
and. Location: UNITED STATES , 72 years of age, Directly after, patient experienced the unwanted or unexpected Sprycel side effects: cognitive disorder, somnolence, activities of daily living impaired, mobility decreased, decreased appetite, lethargy, depressed level of consciousness.
Associated medications used:
  • Temozolomide (75 Mg/m2;;po)
Patient was hospitalized.

Neoplasm Malignant, Hepatitis B, Transaminases Increased (8385710-6)
on May 15, 2012 Male from ITALY , 64 years of age, was diagnosed with
  • chronic myeloid leukaemia
  • non-hodgkin's lymphoma
and was treated with Sprycel. Patient felt the following Sprycel side effects: neoplasm malignant, hepatitis b, transaminases increased. Sprycel dosage: Inter On 23feb12. Patient was hospitalized.

Chromosomal Deletion, Headache (8383187-8)
on May 15, 2012 Female from UNITED STATES , 61 years of age, weighting 180.8 lb, was diagnosed with
  • chronic myeloid leukaemia
and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: chromosomal deletion, headache. Sprycel dosage: N/A.

Haemorrhage, Epilepsy, Hypoxic-ischaemic Encephalopathy, Hypocalcaemia (8383177-5)
Patient was taking Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: haemorrhage, epilepsy, hypoxic-ischaemic encephalopathy, hypocalcaemia on May 22, 2012 from GERMANY Additional patient health information: Male , 71 years of age, weighting 143.3 lb, was diagnosed with
  • acute myeloid leukaemia
and. Sprycel dosage: Intd 24apr12.
Associated medications used:
  • Cytarabine (Intd 01apr12)
Patient was hospitalized.

Cardiac Failure (8380730-X)
Adverse event was reported on May 14, 2012 by a Male taking Sprycel (Dosage: N/A) was diagnosed with
  • chronic myeloid leukaemia
and. Location: JAPAN , 74 years of age, Patient felt the following Sprycel side effects: cardiac failure.

Acute Lymphocytic Leukaemia (8378856-X)
on May 14, 2012 Male from UNITED STATES , 33 years of age, was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: acute lymphocytic leukaemia. Sprycel dosage: N/A. Patient was hospitalized.

Respiratory Tract Infection, Pleural Effusion, Ascites, Pericardial Effusion, Polyserositis (8378855-8)
on May 15, 2012 Female from PORTUGAL , 74 years of age, weighting 77.16 lb, was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: respiratory tract infection, pleural effusion, ascites, pericardial effusion, polyserositis. Sprycel dosage: N/A. Patient was hospitalized.

Trismus (8378790-5)
Patient was taking Sprycel. Patient felt the following Sprycel side effects: trismus on May 14, 2012 from GERMANY Additional patient health information: Female , 53 years of age, weighting 123.5 lb, was diagnosed with
  • acute myeloid leukaemia
and. Sprycel dosage: N/A.
Multiple prescriptions taken:
  • Cytarabine (2x4890mg.)


Insomnia, Weight Decreased, Gait Disturbance, Dysarthria (8378789-9)
Adverse event was reported on May 14, 2012 by a Male taking Sprycel (Dosage: N/A) was diagnosed with
  • chronic myeloid leukaemia
and. Location: UNITED STATES , 74 years of age, After Sprycel was administered, patient encountered several Sprycel side effects: insomnia, weight decreased, gait disturbance, dysarthria.

Hypocalcaemia, Epilepsy, Hypoxic-ischaemic Encephalopathy (8375917-6)
on May 10, 2012 Male from GERMANY , 71 years of age, weighting 143.3 lb, was diagnosed with
  • acute myeloid leukaemia
and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: hypocalcaemia, epilepsy, hypoxic-ischaemic encephalopathy. Sprycel dosage: N/A.
Associated medications used:
  • Cytarabine
Patient was hospitalized.

Platelet Count Decreased (8375911-5)
on May 14, 2012 Male from UNITED STATES , 19 years of age, was treated with Sprycel. Patient felt the following Sprycel side effects: platelet count decreased. Sprycel dosage: N/A.
Multiple prescriptions taken:
  • Hydrea


Acute Lymphocytic Leukaemia, Oncologic Complication, Neoplasm Progression, Neoplasm Malignant (8372290-4)
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: acute lymphocytic leukaemia, oncologic complication, neoplasm progression, neoplasm malignant on May 15, 2012 from UNITED STATES Additional patient health information: Male , 43 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and. Sprycel dosage: N/A.

(8368455-8)
Adverse event was reported on May 15, 2012 by a Female taking Sprycel (Dosage: N/A) was diagnosed with
  • leukaemia
and. Location: UNITED STATES , 74 years of age, .

Neoplasm Malignant, Splenomegaly, Anaemia (8367279-5)
on May 10, 2012 Female from BRAZIL , 60 years of age, weighting 136.7 lb, was diagnosed with
  • chronic myeloid leukaemia
and was treated with Sprycel. Patient felt the following Sprycel side effects: neoplasm malignant, splenomegaly, anaemia. Sprycel dosage: Dose Decreased To 70 Mg/day And Again Increased To 100 Mg/day.

(8367277-1)
on May 11, 2012 Male from UNITED STATES , 43 years of age, was diagnosed with
  • acute leukaemia
and was treated with Sprycel. . Sprycel dosage: N/A.

Gallbladder Disorder (8367254-0)
Patient was taking Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: gallbladder disorder on May 07, 2012 from UNITED STATES Additional patient health information: Female , 58 years of age, . Sprycel dosage: N/A. Patient was hospitalized.

Dyspnoea, Gastrooesophageal Reflux Disease (8359611-3)
Adverse event was reported on May 14, 2012 by a Male taking Sprycel 100mg Po Daily Bristol-myers Squibb (Dosage: Sprycel 100mg Daily Po) . Location: UNITED STATES , 85 years of age, Patient felt the following Sprycel side effects: dyspnoea, gastrooesophageal reflux disease.

Platelet Count Decreased, Stress Fracture, Stomatitis (8353023-4)
on May 02, 2012 Female from UNITED STATES , 54 years of age, was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: platelet count decreased, stress fracture, stomatitis. Sprycel dosage: N/A.

Angiosarcoma Metastatic (8340190-1)
on Apr 26, 2012 Male from FRANCE , 68 years of age, weighting 187.4 lb, was diagnosed with
  • chronic myeloid leukaemia
and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: angiosarcoma metastatic. Sprycel dosage: N/A.
Associated medications used:
  • Gleevec
  • Tasigna (600 Mg 1/d Orally From 08apr-14feb12)
Patient was hospitalized.

Showing 1-25 of 1453 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Sprycel Information

Alternative SPRYCEL Names:DASATINIB

Active Ingredient: DASATINIB

Sprycel Dosage, Warnings, Usage.

Side Effects reported to FDA: 1453. View Sprycel Adverse Reports

Sprycel safety alerts: 2011

Reported deaths: 361

Reported hospitalizations: 653

Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

[Posted 10/11/2011]

AUDIENCE: Hematology, Oncology

ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

BACKGROUND: Sprycel (dasatinib) is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

RECOMMENDATION: Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.

Read the Drug Safety Communication for additional information including a data summary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178



[10/11/2011 - Drug Safety Communication - FDA]

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