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Sprycel Side Effects

Common Sprycel Side Effects

The most commonly reported Sprycel side effects (click to view or check a box to report):

Pleural Effusion (372)
Diarrhoea (216)
Anaemia (202)
Nausea (182)
Fatigue (162)
Platelet Count Decreased (161)
Headache (159)
Malignant Neoplasm Progression (158)
Death (157)
Dyspnoea (138)
White Blood Cell Count Decreased (109)
Rash (105)
Pyrexia (97)
Neutrophil Count Decreased (93)
Gastrointestinal Haemorrhage (86)
Pneumonia (82)
Decreased Appetite (77)
Vomiting (73)
Pulmonary Oedema (67)
Dehydration (61)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Sprycel Side Effects Reported to FDA

The following Sprycel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Sprycel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Abortion Induced, Pregnancy
on Mar 12, 2014 Female from JP , 28 years of age, weighting 136.7 lb, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: abortion induced, pregnancy. Sprycel dosage: N/A.

Malignant Neoplasm Progression, Herpes Virus Infection, Arrhythmia
Patient was taking Sprycel. Patient felt the following Sprycel side effects: malignant neoplasm progression, herpes virus infection, arrhythmia on Mar 21, 2014 from IN Additional patient health information: Male , 62 years of age, was diagnosed with and. Sprycel dosage: N/A.

Renal Failure
Adverse event was reported on Mar 20, 2014 by a Female taking Sprycel (Dosage: N/A) was diagnosed with and. Location: IN , 71 years of age, After Sprycel was administered, patient encountered several Sprycel side effects: renal failure.

Dementia, Fall
on Mar 11, 2014 Female from US , 71 years of age, was diagnosed with and was treated with Sprycel (cml) Tabs 100 Mg. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: dementia, fall. Sprycel (cml) Tabs 100 Mg dosage: N/A.
Associated medications used:
  • Neurontin (Red To 300mg/d)



Blood Creatinine Increased, White Blood Cell Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dermatitis Exfoliative, Gastrointestinal Haemorrhage, Renal Failure Acute
on Mar 10, 2014 Male from JP , 66 years of age, weighting 79.37 lb, was diagnosed with and was treated with Sprycel. Patient felt the following Sprycel side effects: blood creatinine increased, white blood cell count decreased, neutrophil count decreased, platelet count decreased, anaemia, dermatitis exfoliative, gastrointestinal haemorrhage, renal failure acute. Sprycel dosage: 10oct-12oct13?25oct-04nov13?05nov13-15nov13?01dec13-4dec13?05dec13-06dec13?07dec13-10dec13.
Multiple prescriptions taken:
  • Prednisolone (1 Df: 5-45mg)
  • Dalteparin
  • Salobel
  • Potassium Citrate (1 Df: 6 Tabs)
  • Ciproxan
  • Diflucan (Caps)
  • Baraclude
  • Zopiclone
Patient was hospitalized.

Pneumonia
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: pneumonia on Mar 28, 2014 from US Additional patient health information: Male , 65 years of age, . Sprycel dosage: N/A.

Pneumonia, Hypoxia
Adverse event was reported on Mar 07, 2014 by a Female taking Sprycel (Dosage: N/A) was diagnosed with and. Location: US , 68 years of age, Directly after, patient experienced the unwanted or unexpected Sprycel side effects: pneumonia, hypoxia. Patient was hospitalized.

H1n1 Influenza
on Mar 06, 2014 Male from US , 57 years of age, was diagnosed with and was treated with Sprycel (cml) Tabs 100 Mg. Patient felt the following Sprycel side effects: h1n1 influenza. Sprycel (cml) Tabs 100 Mg dosage: N/A. Patient was hospitalized.

Malignant Melanoma Stage Iv, Pulmonary Arterial Hypertension, Pleural Effusion, Pneumonia Legionella, Off Label Use
on Mar 05, 2014 Male from FR , 67 years of age, was diagnosed with and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: malignant melanoma stage iv, pulmonary arterial hypertension, pleural effusion, pneumonia legionella, off label use. Sprycel dosage: N/A.
Multiple concurrent drugs taken:
  • Aerius (Film-coated Tablet)
  • Azantac (Film-coated Tablet)
  • Xyzall (Film-coated Tablet)
  • Coversyl (1df=1 Tab?scored Film-coated Tablet 5mg)
  • Fosamax (1df=1 Tablet?70mg Tabs)
  • Calcium Carbonate + Cholecalciferol
Patient was hospitalized.


Patient was taking Sprycel. on Mar 04, 2014 from US Additional patient health information: Female , 67 years of age, . Sprycel dosage: 1t.

Diarrhoea, Muscle Spasms, Rash, Dyspnoea
Adverse event was reported on Feb 26, 2014 by a Female taking Sprycel (Dosage: N/A) was diagnosed with and. Location: US , 61 years of age, Patient felt the following Sprycel side effects: diarrhoea, muscle spasms, rash, dyspnoea.

Bone Marrow Transplant
on Feb 27, 2014 Female from US , 41 years of age, was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: bone marrow transplant. Sprycel dosage: Tablet. Patient was hospitalized.

Pulmonary Arterial Hypertension
on Feb 21, 2014 Male from US , 75 years of age, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: pulmonary arterial hypertension. Sprycel dosage: N/A.


Patient was taking Sprycel. on Mar 04, 2014 from US Additional patient health information: Male , 66 years of age, . Sprycel dosage: N/A.

Pleural Effusion, Cardiac Disorder, Headache
Adverse event was reported on Feb 24, 2014 by a Male taking Sprycel (Dosage: N/A) was diagnosed with and. Location: US , 62 years of age, After Sprycel was administered, patient encountered several Sprycel side effects: pleural effusion, cardiac disorder, headache. Patient was hospitalized.

Head And Neck Cancer
on Feb 24, 2014 Male from CA , 68 years of age, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: head and neck cancer. Sprycel dosage: N/A.

Cerebral Haemorrhage, Malignant Neoplasm Progression, Head Injury
on Feb 28, 2014 Female from IN , 48 years of age, was diagnosed with and was treated with Sprycel. Patient felt the following Sprycel side effects: cerebral haemorrhage, malignant neoplasm progression, head injury. Sprycel dosage: N/A.

Malignant Neoplasm Progression, Pneumonia
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: malignant neoplasm progression, pneumonia on Mar 07, 2014 from IN Additional patient health information: Male , 51 years of age, was diagnosed with and. Sprycel dosage: N/A. Patient was hospitalized.

Gastrointestinal Disorder, Diarrhoea
Adverse event was reported on Feb 19, 2014 by a Female taking Sprycel (cml) Tabs 100 Mg (Dosage: N/A) was diagnosed with and. Location: AU , 25 years of age, Directly after, patient experienced the unwanted or unexpected Sprycel side effects: gastrointestinal disorder, diarrhoea. Patient was hospitalized.

Pericarditis Constrictive, Lupus-like Syndrome, Pleural Effusion
on Feb 19, 2014 Male from IL , 50 years of age, was diagnosed with and was treated with Sprycel (cml) Tabs 100 Mg. Patient felt the following Sprycel side effects: pericarditis constrictive, lupus-like syndrome, pleural effusion. Sprycel (cml) Tabs 100 Mg dosage: N/A. Patient was hospitalized.

Lymphoma
on Feb 13, 2014 Male from FR , 44 years of age, weighting 167.6 lb, was diagnosed with and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: lymphoma. Sprycel dosage: 11jul2012-29jul2012=50mg?30jul2012-02jan2012=80mg?03jan2014-cont.=60mg.
Multiple concurrent drugs taken:
  • Nexium


Visual Acuity Reduced
Patient was taking Sprycel (cml) Tabs 100 Mg. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: visual acuity reduced on Feb 12, 2014 from FR Additional patient health information: Male , 68 years of age, weighting 189.6 lb, was diagnosed with and. Sprycel (cml) Tabs 100 Mg dosage: N/A.

Nephrolithiasis
Adverse event was reported on Feb 11, 2014 by a Male taking Sprycel (Dosage: N/A) was diagnosed with and. Location: US , 75 years of age, Patient felt the following Sprycel side effects: nephrolithiasis.
Multiple prescriptions taken:
  • Metformin
  • Glyburide
  • Terazosin
  • Finasteride
Patient was hospitalized.

Acute Psychosis
on Feb 10, 2014 Female from IT , 28 years of age, was diagnosed with and was treated with Sprycel (cml) Tabs 100 Mg. After Sprycel was administered, patient encountered several Sprycel side effects: acute psychosis. Sprycel (cml) Tabs 100 Mg dosage: N/A. Patient was hospitalized.

Carditis, Pneumonitis
on Feb 10, 2014 Patient from PE , 39 years of age, was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: carditis, pneumonitis. Sprycel dosage: N/A.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Sprycel Side Effects

    Did You Have a Sprycel Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Sprycel for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative SPRYCEL Names:DASATINIB

    Active Ingredient: DASATINIB

    Sprycel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2564

    Sprycel safety alerts: 2011

    Reported deaths: 531

    Reported hospitalizations: 951

    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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