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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.
Traumatic Haemothorax, Pleural Effusion
This is a report of a 39-year-old male patient (weight: NA) from MX, suffering from the following symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage: NA, start time: May 15, 2009), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Traumatic Haemothorax
  • Pleural Effusion
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in death side effect. The patient was hospitalized.

Skin Reaction
This report suggests a potential Sprycel Skin Reaction side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: NA) starting NS. Soon after starting Sprycel the patient began experiencing various side effects, including:
  • Skin Reaction
Drugs used concurrently: NA. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as skin reaction, may still occur.

Multi-organ Failure, Hyperkalaemia, Upper Gastrointestinal Haemorrhage, Myocardial Infarction, Platelet Count Decreased
This Multi-organ Failure, Hyperkalaemia, Upper Gastrointestinal Haemorrhage, Myocardial Infarction, Platelet Count Decreased problem was reported by a consumer or non-health professional from US. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia. On Aug 09, 2013 this consumer started treatment with Sprycel (dosage: Total No. Of Course:6?last Dose:07jan2014). The following drugs were being taken at the same time:
  • Etoposide (Last Dose On 14nov2013)
  • Cytarabine (Last Dose On 15nov2013)
  • Dexamethasone (Last Dose On 24dec2013?oral Route Also)
  • Mercaptopurine (Last Dose On 06jan2014)
  • Methotrexate (Last Dose On 25dec2013?oral Route Also)
  • Vincristine Sulfate (Last Dose On 20dec2013)
When commencing Sprycel, the patient experienced the following unwanted symptoms/side effects:
  • Multi-organ Failure
  • Hyperkalaemia
  • Upper Gastrointestinal Haemorrhage
  • Myocardial Infarction
  • Platelet Count Decreased
The 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 multi-organ failure, may become evident only after a product is in use by the general population.

Angioedema, Pleural Effusion, Hypersensitivity, Uvulitis
This is a report of a 83-year-old female patient (weight: NA) from ES. The patient developed the following symptoms/conditions: chronic myeloid leukaemia and was treated with Sprycel (dosage: Restarted At A Dose Of 40 Mg/day.) starting 200406. Concurrently used drugs:
  • Omeprazole
  • Enalapril
  • Simvastatine
  • Doxazosin
  • Lantus
Soon after that, the consumer experienced the following side effects:
  • Angioedema
  • Pleural Effusion
  • Hypersensitivity
  • Uvulitis
The patient was hospitalized. This opens a possibility that Sprycel treatment could cause the above reactions, including angioedema, and some female subjects may be more susceptible.


Rash, Pericardial Effusion
A 59-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Sprycel treatment (dosage: NA) on Jan 14, 2014. Soon after starting Sprycel treatment, the subject experienced various side effects, including:
  • Rash
  • Pericardial Effusion
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Sprycel.

Prostatic Disorder, Haemothorax, Diarrhoea
A 76-year-old male patient from US (weight: NA) experienced symptoms, such as: chronic myeloid leukaemia and was treated with Sprycel(dosage: Dose Reduced To 50 Mg). The treatment was initiated on May 15, 2012. After that a consumer reported the following side effect(s):
  • Prostatic Disorder
  • Haemothorax
  • Diarrhoea
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Sprycel efficacy:
  • Metoprolol
  • Folic Acid
  • Allopurinol
  • Quinapril
  • Potassium Citrate
  • Lovaza (2 Caps)
  • Aspirin
  • Lipitor
The patient was hospitalized.

Lymphoplasmacytoid Lymphoma/immunocytoma, Asthenia, Nasopharyngitis
In this report, Sprycel (cml) Tabs 100 Mg was administered for the following condition: chronic myeloid leukaemia.A 60-year-old female consumer from FR (weight: NA) started Sprycel (cml) Tabs 100 Mg treatment (dosage: NA) on Jan 11, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Lymphoplasmacytoid Lymphoma/immunocytoma
  • Asthenia
  • Nasopharyngitis
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Sprycel (cml) Tabs 100 Mg treatment could be related to the listed above side effect(s).

Adverse Event
This is a report of the following Sprycel (ph+all) Tabs 70 Mg side effect(s):
  • Adverse Event
A 29-year-old male patient from CO (weight: NA) presented with the following condition: acute lymphocytic leukaemia and received a treatment with Sprycel (ph+all) Tabs 70 Mg (dosage: NA) starting: Dec 04, 2012.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Sprycel (ph+all) Tabs 70 Mg treatment could be associated with the listed above side effect(s).

Sepsis, Multi-organ Failure, Gastrointestinal Haemorrhage, Hepatic Failure, Renal Failure Acute, Hypernatraemia, Disseminated Intravascular Coagulation, Hyperglycaemia, Febrile Neutropenia
This Sprycel report was submitted by a 63-year-old male consumer from JP (weight: NA). The patient was diagnosed with: acute lymphocytic leukaemia and Sprycel was administered (dosage: 16f-1mr13:100mg/1/d.2-19mr:70mg/2/d.3ap-24ap:70mg/1/d.4-16my:100mg/1/d.11jun-7jl:70mg/1/d.) starting: Mar 22, 2013. The consumer developed a set of symptoms:
  • Sepsis
  • Multi-organ Failure
  • Gastrointestinal Haemorrhage
  • Hepatic Failure
  • Renal Failure Acute
  • Hypernatraemia
  • Disseminated Intravascular Coagulation
  • Hyperglycaemia
  • Febrile Neutropenia
Other drugs used simultaneously:
  • Lasix (8jl-9jl:iv, 17my-3jun:40mg/d Oral)
  • Methotrexate (Inj:intraspinal-10mg:12f13,25mr,30ap,11jun?iv:30ap)
  • Cylocide (Iv:3200mg-13f-14f.1my-2my?is:25mr,30ap,11jun)
  • Predonine (Is:30ap,11ju, ?po:90mg 10jun-16jun.5-70mg 17jun-23jun.5-20mg 4ap-7ap13.100mg-25mr.40-80mg-1ap-3ap)
  • Solu-medrol (Inj.100mg-30ap-2my13.)
  • Oncovin (Inj.1.9mg-10ju13.)
  • Daunomycin (Inj:45mg-10jun13)
  • Endoxan Inj
The patient was hospitalized.Those unexpected symptoms could be linked to a Sprycel treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.


This is a report of a possible correlation between Sprycel use and the following symptoms/side effect(s):
    which could contribute to an assessment of Sprycel risk profile.A 70-year-old male consumer from US (weight: NA) was suffering from NA and was treated with Sprycel (dosage: Tabs) starting Dec 21, 2010.Other concurrent medications: NA.

    Cardiac Failure
    A 81-year-old female patient from JP (weight: NA) presented with the following symptoms: chronic myeloid leukaemia and after a treatment with Sprycel (dosage: NA) experienced the following side effect(s):
    • Cardiac Failure
    The treatment was started on Jul 01, 2013. Sprycel was used in combination with the following drugs:
    • Amlodin (Tabs)
    This report could alert potential Sprycel consumers.

    Pulmonary Oedema
    In this report, a 68-year-old male patient from US (weight: NA) was affected by a possible Sprycel side effect.The patient was diagnosed with NA. After a treatment with Sprycel (dosage: NA, start date: Jan 29, 2013), the patient experienced the following side effect(s):
    • Pulmonary Oedema
    The following simultaneously used drugs could have led to this reaction:
    • Lumigan
    • Clobetasol
    • Carvedilol
    • Pravastatin
    • Lantus
    • Losartan Hctz
    • Furosemide
    • Tylenol
    The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Sprycel treatment.

    Abortion Spontaneous, Pregnancy
    This is a report of a 27-year-old female patient from JP (weight: NA), who used Sprycel (dosage: NA) for a treatment of chronic myeloid leukaemia. After starting a treatment on Nov 01, 2011, the patient experienced the following side effect(s):
    • Abortion Spontaneous
    • Pregnancy
    The following drugs could possibly have interacted with the Sprycel treatment NA.Taken together, these observations suggest that a Sprycel treatment could be related to side effect(s), such as Abortion Spontaneous, Pregnancy.

    Malignant Neoplasm Progression, Shock Haemorrhagic, Thrombocytopenia, Pleural Effusion, Full Blood Count Decreased, Decreased Appetite, Tardive Dyskinesia
    This malignant neoplasm progression side effect was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: acute lymphocytic leukaemia. The patient was prescribed Sprycel (ph+all) Tabs (dosage: NA), which was started on Nov 15, 2011. Concurrently used drugs:
    • Prochlorperazine
    When starting to take Sprycel (ph+all) Tabs the consumer reported the following symptoms:
    • Malignant Neoplasm Progression
    • Shock Haemorrhagic
    • Thrombocytopenia
    • Pleural Effusion
    • Full Blood Count Decreased
    • Decreased Appetite
    • Tardive Dyskinesia
    The patient was hospitalized. These side effects may potentially be related to Sprycel (ph+all) Tabs.

    Nervous System Disorder
    This is a Sprycel side effect report of a 50-year-old male patient (weight:NA) from IT, suffering from the following symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a nervous system disorder side effect. The patient presented with:
    • Nervous System Disorder
    which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Sprycel treatment in male patients suffering from chronic myeloid leukaemia, resulting in nervous system disorder.

    Cardiac Failure, Stress Cardiomyopathy, Sepsis, Pleural Effusion
    This report suggests a potential Sprycel cardiac failure side effect(s) that can have serious consequences. A 68-year-old female patient from JP (weight:NA) was diagnosed with the following health condition(s): chronic myeloid leukaemia and used Sprycel (dosage: NA) starting Sep 27, 2013. Soon after starting Sprycel the patient began experiencing various side effects, including:
    • Cardiac Failure
    • Stress Cardiomyopathy
    • Sepsis
    • Pleural Effusion
    Drugs used concurrently:NA. The patient was hospitalized. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cardiac failure, may still occur.

    Basal Cell Carcinoma, Squamous Cell Carcinoma, Hyperkeratosis, Dry Skin, Eczema, Rash Macular, Fatigue
    This basal cell carcinoma problem was reported by a consumer or non-health professional from AU. A 60-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): chronic myeloid leukaemia.On Dec 07, 2012 a consumer started treatment with Sprycel (cml) Tabs 100 Mg (dosage: Halving The Dose For 7 Days). The following drugs/medications were being taken at the same time: NA. When commencing Sprycel (cml) Tabs 100 Mg, the patient experienced the following unwanted symptoms /side effects:
    • Basal Cell Carcinoma
    • Squamous Cell Carcinoma
    • Hyperkeratosis
    • Dry Skin
    • Eczema
    • Rash Macular
    • Fatigue
    Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as basal cell carcinoma, may become evident only after a product is in use by the general population.

    Adenocarcinoma Pancreas
    This is a Sprycel side effect report of a 67-year-old male patient (weight: NA) from FR. The patient developed the following symptoms/conditions: NA and was treated with Sprycel (dosage: NA) starting 201111. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
    • Adenocarcinoma Pancreas
    The patient was hospitalized. This opens a possibility that Sprycel could cause adenocarcinoma pancreas and that some male patients may be more susceptible.

    Acute Myocardial Infarction, Left Ventricular Dysfunction
    A 70-year-old male patient (weight: NA) from GB with the following symptoms: chronic myeloid leukaemia started Sprycel treatment (dosage: NA) on NS. Soon after starting Sprycel treatment, the consumer experienced several side effects, including:
    • Acute Myocardial Infarction
    • Left Ventricular Dysfunction
    . Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Sprycel side effects, such as acute myocardial infarction.

    Malignant Neoplasm Progression
    This malignant neoplasm progression side effect was reported by a physician from IN. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (dosage: NA), which was started on Nov 25, 2013. Concurrently used drugs: NA..When starting to take Sprycel the consumer reported symptoms, such as:
    • Malignant Neoplasm Progression
    These side effects may potentially be related to Sprycel.

    Gamma-glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased
    This is a report of a 83-year-old male patient (weight: NA) from JP, suffering from the following symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (dosage: 70mg:30jun09-21jul09?70mg:28jul09-10sep09?50mg:15oct09 -ong, start time: Sep 18, 2009), combined with:
    • Zyloric (Initial Dose:stop Date 10nov2009(tablet)?2nd Dose:start Date 11nov2009(oral)(tablet))
    • Potassium Aspartate
    and developed a serious reaction and side effect(s). The consumer presented with:
    • Gamma-glutamyltransferase Increased
    • Aspartate Aminotransferase Increased
    • Alanine Aminotransferase Increased
    • Blood Alkaline Phosphatase Increased
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in gamma-glutamyltransferase increased side effect.

    Fatigue, White Blood Cell Count Decreased
    This report suggests a potential Sprycel Fatigue, White Blood Cell Count Decreased side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: leukaemia and used Sprycel (dosage: NA) starting Dec 02, 2013. Soon after starting Sprycel the patient began experiencing various side effects, including:
    • Fatigue
    • White Blood Cell Count Decreased
    Drugs used concurrently: NA.The patient was hospitalized. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as fatigue, may still occur.

    Cardiac Arrest, Pneumothorax, Fluid Retention
    This Cardiac Arrest, Pneumothorax, Fluid Retention problem was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: leukaemia. On NS this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time:
    • Lasix
    • Diltiazem Hcl
    • Potassium
    • Diamox
    • Singulair
    • Elavil
    • Prilosec (1df= 1 Capsule.?20mg)
    • Temodar
    When commencing Sprycel, the patient experienced the following unwanted symptoms/side effects:
    • Cardiac Arrest
    • Pneumothorax
    • Fluid Retention
    The 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 cardiac arrest, may become evident only after a product is in use by the general population.

    Chylothorax
    This is a report of a 58-year-old female patient (weight: NA) from SE. The patient developed the following symptoms/conditions: chronic myeloid leukaemia and was treated with Sprycel (dosage: 70mg 11mar13-14may13,50mg 15may13-12jun13) starting Jul 29, 2011. Concurrently used drugs:
    • Lyrica
    • Oxycontin
    Soon after that, the consumer experienced the following side effects:
    • Chylothorax
    The patient was hospitalized. This opens a possibility that Sprycel treatment could cause the above reactions, including chylothorax, and some female subjects may be more susceptible.

    Cardiac Arrest
    A 47-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Sprycel treatment (dosage: NA) on Nov 08, 2013. Soon after starting Sprycel treatment, the subject experienced various side effects, including:
    • Cardiac Arrest
    Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Sprycel.

      2 of 103 



    Top 10 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

    Top 10 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

    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

    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

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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

    Latest Sprycel clinical trials