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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#9885773
Traumatic Haemothorax, Pleural Effusion
This is a report of a 39-year-old male patient (weight: NA) from MX, suffering from the following health 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): Traumatic Haemothorax, Pleural Effusion 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.
Sprycel Side Effect Report#9882511
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. After starting Sprycel the patient began experiencing various side effects, including: Skin ReactionAdditional 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.
Sprycel Side Effect Report#9871469
Multi-organ Failure, Hyperkalaemia, Upper Gastrointestinal Haemorrhage, Myocardial Infarction, Platelet Count Decreased
This Multi-organ Failure 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 using Sprycel, the patient experienced the following unwanted symptoms/side effects: Multi-organ Failure, Hyperkalaemia, Upper Gastrointestinal Haemorrhage, Myocardial Infarction, Platelet Count DecreasedThe 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.
Sprycel Side Effect Report#9867987
Angioedema, Pleural Effusion, Hypersensitivity, Uvulitis
This Angioedema side effect was reported by a physician from ES. A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (drug dosage: Restarted At A Dose Of 40 Mg/day.), which was initiated on 200406. Concurrently used drugs:
  • Omeprazole
  • Enalapril
  • Simvastatine
  • Doxazosin
  • Lantus
.After starting to take Sprycel the consumer reported adverse symptoms, such as: Angioedema, Pleural Effusion, Hypersensitivity, UvulitisThese side effects may potentially be related to Sprycel. The patient was hospitalized.
Sprycel Side Effect Report#9867156
Rash, Pericardial Effusion
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Sprycel (dosage: NA, start time:
Jan 14, 2014), combined with: NA. and developed a serious reaction and side effect(s): Rash, Pericardial Effusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in female patients, resulting in Rash side effect.
Sprycel Side Effect Report#9862288
Prostatic Disorder, Haemothorax, Diarrhoea
This report suggests a potential Sprycel Prostatic Disorder side effect(s) that can have serious consequences. A 76-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia and used Sprycel (dosage: Dose Reduced To 50 Mg) starting
May 15, 2012. After starting Sprycel the patient began experiencing various side effects, including: Prostatic Disorder, Haemothorax, DiarrhoeaAdditional drugs used concurrently:
  • Metoprolol
  • Folic Acid
  • Allopurinol
  • Quinapril
  • Potassium Citrate
  • Lovaza (2 Caps)
  • Aspirin
  • Lipitor
The patient was hospitalized. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Prostatic Disorder, may still occur.
Sprycel Side Effect Report#9859236
Lymphoplasmacytoid Lymphoma/immunocytoma, Asthenia, Nasopharyngitis
This Lymphoplasmacytoid Lymphoma/immunocytoma problem was reported by a consumer or non-health professional from FR. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Jan 11, 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: Lymphoplasmacytoid Lymphoma/immunocytoma, Asthenia, NasopharyngitisThe 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 Lymphoplasmacytoid Lymphoma/immunocytoma, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9857052
Adverse Event
This Death side effect was reported by a consumer or non-health professional from CO. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: acute lymphocytic leukaemia.The patient was prescribed Sprycel (ph+all) Tabs 70 Mg (drug dosage: NA), which was initiated on
Dec 04, 2012. Concurrently used drugs: NA..After starting to take Sprycel (ph+all) Tabs 70 Mg the consumer reported adverse symptoms, such as: Adverse EventThese side effects may potentially be related to Sprycel (ph+all) Tabs 70 Mg. The patient was hospitalized.
Sprycel Side Effect Report#9854119
Sepsis, Multi-organ Failure, Gastrointestinal Haemorrhage, Hepatic Failure, Renal Failure Acute, Hypernatraemia, Disseminated Intravascular Coagulation, Hyperglycaemia, Febrile Neutropenia
This is a report of a 63-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: acute lymphocytic leukaemia, who was treated with Sprycel (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., start time:
Mar 22, 2013), combined with:
  • 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
and developed a serious reaction and side effect(s): Sepsis, Multi-organ Failure, Gastrointestinal Haemorrhage, Hepatic Failure, Renal Failure Acute, Hypernatraemia, Disseminated Intravascular Coagulation, Hyperglycaemia, Febrile Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in male patients, resulting in Sepsis side effect. The patient was hospitalized.
Sprycel Side Effect Report#9850941
This report suggests a potential Sprycel Death side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: Tabs) starting
Dec 21, 2010. 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#9838914
Cardiac Failure
This Cardiac Failure problem was reported by a consumer or non-health professional from JP. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On
Jul 01, 2013 this consumer started treatment with Sprycel (dosage: NA). The following drugs were being taken at the same time:
  • Amlodin (Tabs)
When using Sprycel, the patient experienced the following unwanted symptoms/side effects: Cardiac FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9838889
Pulmonary Oedema
This Pulmonary Oedema side effect was reported by a pharmacist from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sprycel (drug dosage: NA), which was initiated on
Jan 29, 2013. Concurrently used drugs:
  • Lumigan
  • Clobetasol
  • Carvedilol
  • Pravastatin
  • Lantus
  • Losartan Hctz
  • Furosemide
  • Tylenol
.After starting to take Sprycel the consumer reported adverse symptoms, such as: Pulmonary OedemaThese side effects may potentially be related to Sprycel. The patient was hospitalized.
Sprycel Side Effect Report#9838580
Abortion Spontaneous, Pregnancy
This is a report of a 27-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:
Nov 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Abortion Spontaneous, 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 Spontaneous side effect.
Sprycel Side Effect Report#9832285
Malignant Neoplasm Progression, Shock Haemorrhagic, Thrombocytopenia, Pleural Effusion, Full Blood Count Decreased, Decreased Appetite, Tardive Dyskinesia
This report suggests a potential Sprycel (ph+all) Tabs Malignant Neoplasm Progression side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: acute lymphocytic leukaemia and used Sprycel (ph+all) Tabs (dosage: NA) starting
Nov 15, 2011. After starting Sprycel (ph+all) Tabs the patient began experiencing various side effects, including: Malignant Neoplasm Progression, Shock Haemorrhagic, Thrombocytopenia, Pleural Effusion, Full Blood Count Decreased, Decreased Appetite, Tardive DyskinesiaAdditional drugs used concurrently:
  • Prochlorperazine
The patient was hospitalized. Although Sprycel (ph+all) Tabs demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malignant Neoplasm Progression, may still occur.
Sprycel Side Effect Report#9820997
Nervous System Disorder
This Nervous System Disorder problem was reported by a physician from IT. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On NS 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: Nervous System DisorderThe 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 Nervous System Disorder, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9813707
Cardiac Failure, Stress Cardiomyopathy, Sepsis, Pleural Effusion
This Cardiac Failure side effect was reported by a consumer or non-health professional from JP. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (drug dosage: NA), which was initiated on
Sep 27, 2013. Concurrently used drugs: NA..After starting to take Sprycel the consumer reported adverse symptoms, such as: Cardiac Failure, Stress Cardiomyopathy, Sepsis, Pleural EffusionThese side effects may potentially be related to Sprycel. The patient was hospitalized.
Sprycel Side Effect Report#9806318
Basal Cell Carcinoma, Squamous Cell Carcinoma, Hyperkeratosis, Dry Skin, Eczema, Rash Macular, Fatigue
This is a report of a 60-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: chronic myeloid leukaemia, who was treated with Sprycel (cml) Tabs 100 Mg (dosage: Halving The Dose For 7 Days, start time:
Dec 07, 2012), combined with: NA. and developed a serious reaction and side effect(s): Basal Cell Carcinoma, Squamous Cell Carcinoma, Hyperkeratosis, Dry Skin, Eczema, Rash Macular, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel (cml) Tabs 100 Mg treatment in male patients, resulting in Basal Cell Carcinoma side effect.
Sprycel Side Effect Report#9804559
Adenocarcinoma Pancreas
This report suggests a potential Sprycel Adenocarcinoma Pancreas side effect(s) that can have serious consequences. A 67-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Sprycel (dosage: NA) starting 201111. After starting Sprycel the patient began experiencing various side effects, including: Adenocarcinoma PancreasAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sprycel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adenocarcinoma Pancreas, may still occur.
Sprycel Side Effect Report#9802180
Acute Myocardial Infarction, Left Ventricular Dysfunction
This Acute Myocardial Infarction problem was reported by a consumer or non-health professional from GB. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic myeloid leukaemia. On NS 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: Acute Myocardial Infarction, Left Ventricular DysfunctionThe 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 Acute Myocardial Infarction, may become evident only after a product is in use by the general population.
Sprycel Side Effect Report#9801994
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 (drug dosage: NA), which was initiated on
Nov 25, 2013. Concurrently used drugs: NA..After starting to take Sprycel the consumer reported adverse symptoms, such as: Malignant Neoplasm ProgressionThese side effects may potentially be related to Sprycel.
Sprycel Side Effect Report#9800959
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 health 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): Gamma-glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased 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.
Sprycel Side Effect Report#9799827
Fatigue, White Blood Cell Count Decreased
This report suggests a potential Sprycel Fatigue 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. After starting Sprycel the patient began experiencing various side effects, including: Fatigue, White Blood Cell Count DecreasedAdditional 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.
Sprycel Side Effect Report#9796402
Cardiac Arrest, Pneumothorax, Fluid Retention
This Cardiac Arrest 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 using Sprycel, the patient experienced the following unwanted symptoms/side effects: Cardiac Arrest, Pneumothorax, Fluid RetentionThe 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.
Sprycel Side Effect Report#9790676
Chylothorax
This Chylothorax side effect was reported by a physician from SE. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic myeloid leukaemia.The patient was prescribed Sprycel (drug dosage: 70mg 11mar13-14may13,50mg 15may13-12jun13), which was initiated on
Jul 29, 2011. Concurrently used drugs:
  • Lyrica
  • Oxycontin
.After starting to take Sprycel the consumer reported adverse symptoms, such as: ChylothoraxThese side effects may potentially be related to Sprycel. The patient was hospitalized.
Sprycel Side Effect Report#9788725
Cardiac Arrest
This is a report of a 47-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Sprycel (dosage: NA, start time:
Nov 08, 2013), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sprycel treatment in female patients, resulting in Cardiac Arrest side effect. The patient was hospitalized.

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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.

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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