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Sprycel Side Effects

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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.

Sprycel Side Effects Reported to FDA



Sprycel Side Effect Report#9999648
Abortion Induced, Pregnancy
This is a report of a 28-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage: NA, start time:
Oct 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Abortion Induced, Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in female patients, resulting in Abortion Induced side effect.
Sprycel Side Effect Report#9998263
Malignant Neoplasm Progression, Herpes Virus Infection, Arrhythmia
This report suggests a potential Sprycel Malignant Neoplasm Progression side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia and used Sprycel (dosage: NA) starting
Oct 16, 2013. After starting Sprycel the patient began experiencing various side effects, including: Malignant Neoplasm Progression, Herpes Virus Infection, ArrhythmiaAdditional drugs used concurrently: NA. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malignant Neoplasm Progression, may still occur.
Sprycel Side Effect Report#9996556
Renal Failure
This Renal Failure problem was reported by a physician from IN. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Jun 07, 2013 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time: NA. When using Sprycel, the patient experienced the following unwanted symptoms/side effects: Renal FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9994596
Dementia, Fall
This Dementia side effect was reported by a physician from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (cml) Tabs 100 Mg (drug dosage: NA), which was initiated on 200911. Concurrently used drugs:
  • Neurontin (Red To 300mg/d)
.After starting to take Sprycel (cml) Tabs 100 Mg the consumer reported adverse symptoms, such as: Dementia, FallThese side effects may potentially be related to Sprycel (cml) Tabs 100 Mg.
Sprycel Side Effect Report#9988618
Blood Creatinine Increased, White Blood Cell Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dermatitis Exfoliative, Gastrointestinal Haemorrhage, Renal Failure Acute
This is a report of a 66-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: acute lymphocytic leukaemia, who was treated with Sprycel (dosage: 10oct-12oct13?25oct-04nov13?05nov13-15nov13?01dec13-4dec13?05dec13-06dec13?07dec13-10dec13, start time:
Oct 13, 2013), combined with:
  • Prednisolone (1 Df: 5-45mg)
  • Dalteparin
  • Salobel
  • Potassium Citrate (1 Df: 6 Tabs)
  • Ciproxan
  • Diflucan (Caps)
  • Baraclude
  • Zopiclone
and developed a serious reaction and side effect(s): Blood Creatinine Increased, White Blood Cell Count Decreased, Neutrophil Count Decreased, Platelet Count Decreased, Anaemia, Dermatitis Exfoliative, Gastrointestinal Haemorrhage, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in Blood Creatinine Increased side effect. The patient was hospitalized.
Sprycel Side Effect Report#9988238
Pneumonia
This report suggests a potential Sprycel Death side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: NA) starting
Aug 14, 2012. After starting Sprycel the patient began experiencing various side effects, including: PneumoniaAdditional drugs used concurrently: NA. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Sprycel Side Effect Report#9981425
Pneumonia, Hypoxia
This Pneumonia problem was reported by a physician from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia. On
Dec 18, 2013 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time: NA. When using Sprycel, the patient experienced the following unwanted symptoms/side effects: Pneumonia, HypoxiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9972692
H1n1 Influenza
This Death side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: myeloid leukaemia.The patient was prescribed Sprycel (cml) Tabs 100 Mg (drug dosage: NA), which was initiated on
Sep 17, 2013. Concurrently used drugs: NA..After starting to take Sprycel (cml) Tabs 100 Mg the consumer reported adverse symptoms, such as: H1n1 InfluenzaThese side effects may potentially be related to Sprycel (cml) Tabs 100 Mg. The patient was hospitalized.
Sprycel Side Effect Report#9963336
Malignant Melanoma Stage Iv, Pulmonary Arterial Hypertension, Pleural Effusion, Pneumonia Legionella, Off Label Use
This is a report of a 67-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: mastocytosis, who was treated with Sprycel (dosage: NA, start time: 201005), combined with:
  • 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
and developed a serious reaction and side effect(s): Malignant Melanoma Stage Iv, Pulmonary Arterial Hypertension, Pleural Effusion, Pneumonia Legionella, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in Malignant Melanoma Stage Iv side effect. The patient was hospitalized.
Sprycel Side Effect Report#9948948
This report suggests a potential Sprycel Death side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: 1t) starting NS. After starting Sprycel the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Sprycel Side Effect Report#9928484
Diarrhoea, Muscle Spasms, Rash, Dyspnoea
This Diarrhoea problem was reported by a consumer or non-health professional from US. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Jan 20, 2014 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time: NA. When using Sprycel, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Muscle Spasms, Rash, DyspnoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9927765
Bone Marrow Transplant
This Bone Marrow Transplant side effect was reported by a consumer or non-health professional from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sprycel (drug dosage: Tablet), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sprycel the consumer reported adverse symptoms, such as: Bone Marrow TransplantThese side effects may potentially be related to Sprycel. The patient was hospitalized.
Sprycel Side Effect Report#9921467
Pulmonary Arterial Hypertension
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage: NA, start time:
Feb 11, 2011), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Arterial Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in Pulmonary Arterial Hypertension side effect.
Sprycel Side Effect Report#9919683
This report suggests a potential Sprycel Death side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: NA) starting NS. After starting Sprycel the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Sprycel Side Effect Report#9918648
Pleural Effusion, Cardiac Disorder, Headache
This Pleural Effusion problem was reported by a physician from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On 2013 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time: NA. When using Sprycel, the patient experienced the following unwanted symptoms/side effects: Pleural Effusion, Cardiac Disorder, HeadacheThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pleural Effusion, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9918639
Head And Neck Cancer
This Head And Neck Cancer side effect was reported by a consumer or non-health professional from CA. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (drug dosage: NA), which was initiated on
Jun 21, 2012. Concurrently used drugs: NA..After starting to take Sprycel the consumer reported adverse symptoms, such as: Head And Neck CancerThese side effects may potentially be related to Sprycel.
Sprycel Side Effect Report#9918637
Cerebral Haemorrhage, Malignant Neoplasm Progression, Head Injury
This is a report of a 48-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage: NA, start time:
Dec 31, 2011), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Haemorrhage, Malignant Neoplasm Progression, Head Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in female patients, resulting in Cerebral Haemorrhage side effect.
Sprycel Side Effect Report#9915528
Malignant Neoplasm Progression, Pneumonia
This report suggests a potential Sprycel Malignant Neoplasm Progression side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia and used Sprycel (dosage: NA) starting
Jul 12, 2013. After starting Sprycel the patient began experiencing various side effects, including: Malignant Neoplasm Progression, PneumoniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malignant Neoplasm Progression, may still occur.
Sprycel Side Effect Report#9912118
Gastrointestinal Disorder, Diarrhoea
This Gastrointestinal Disorder problem was reported by a health professional from AU. A 25-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Nov 26, 2013 this consumer started treatment with Sprycel (cml) Tabs 100 Mg (dosage: NA). The following drugs were being taken at the same time: NA. When using Sprycel (cml) Tabs 100 Mg, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Disorder, DiarrhoeaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrointestinal Disorder, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9912116
Pericarditis Constrictive, Lupus-like Syndrome, Pleural Effusion
This Pericarditis Constrictive side effect was reported by a consumer or non-health professional from IL. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (cml) Tabs 100 Mg (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sprycel (cml) Tabs 100 Mg the consumer reported adverse symptoms, such as: Pericarditis Constrictive, Lupus-like Syndrome, Pleural EffusionThese side effects may potentially be related to Sprycel (cml) Tabs 100 Mg. The patient was hospitalized.
Sprycel Side Effect Report#9894443
Lymphoma
This is a report of a 44-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: chronic myeloid leukaemia,gastrooesophageal reflux disease, who was treated with Sprycel (dosage: 11jul2012-29jul2012=50mg?30jul2012-02jan2012=80mg?03jan2014-cont.=60mg, start time: 2013), combined with:
  • Nexium
and developed a serious reaction and side effect(s): Lymphoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in Lymphoma side effect.
Sprycel Side Effect Report#9890264
Visual Acuity Reduced
This report suggests a potential Sprycel (cml) Tabs 100 Mg Visual Acuity Reduced side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia and used Sprycel (cml) Tabs 100 Mg (dosage: NA) starting
Aug 11, 2011. After starting Sprycel (cml) Tabs 100 Mg the patient began experiencing various side effects, including: Visual Acuity ReducedAdditional drugs used concurrently: NA. Although Sprycel (cml) Tabs 100 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Acuity Reduced, may still occur.
Sprycel Side Effect Report#9888748
Nephrolithiasis
This Nephrolithiasis problem was reported by a health professional from US. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Nov 21, 2013 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time:
  • Metformin
  • Glyburide
  • Terazosin
  • Finasteride
When using Sprycel, the patient experienced the following unwanted symptoms/side effects: NephrolithiasisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nephrolithiasis, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9885787
Acute Psychosis
This Acute Psychosis side effect was reported by a consumer or non-health professional from IT. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (cml) Tabs 100 Mg (drug dosage: NA), which was initiated on
Dec 10, 2013. Concurrently used drugs: NA..After starting to take Sprycel (cml) Tabs 100 Mg the consumer reported adverse symptoms, such as: Acute PsychosisThese side effects may potentially be related to Sprycel (cml) Tabs 100 Mg. The patient was hospitalized.
Sprycel Side Effect Report#9885780
Carditis, Pneumonitis
This is a report of a 39-year-old patient (weight: NA) from PE, suffering from the following health symptoms/conditions: NA, who was treated with Sprycel (dosage: NA, start time:
Jan 28, 2014), combined with: NA. and developed a serious reaction and side effect(s): Carditis, Pneumonitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in patients, resulting in Carditis side effect.


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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.


What are common Sprycel Side Effects for Women?

Women Side EffectsReports
Pleural Effusion 174
Nausea 117
Diarrhoea 116
Anaemia 112
Headache 87
Platelet Count Decreased 86
Dyspnoea 74
Fatigue 71
Malignant Neoplasm Progression 66
White Blood Cell Count Decreased 62

What are common Sprycel Side Effects for Men?

Men Side EffectsReports
Pleural Effusion 195
Diarrhoea 100
Death 95
Fatigue 91
Anaemia 90
Malignant Neoplasm Progression 90
Platelet Count Decreased 75
Headache 71
Nausea 65
Dyspnoea 64

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

    Discuss Sprycel Side Effects

    Did You Have a Sprycel Side Effect?

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    Yes, Moderate
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    How Effective is Sprycel for You?

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    Sprycel Safety Alerts, Active Ingredients, Usage Information

    NDC0003-0524
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSPRYCEL
    Namedasatinib
    Dosage FormTABLET
    RouteORAL
    On market since20060627
    LabelerE.R. Squibb & Sons, L.L.C.
    Active Ingredient(s)DASATINIB
    Strength(s)70
    Unit(s)mg/1
    Pharma ClassKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

    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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