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Sprycel Side Effects

Report Sprycel Side Effects

If you experienced any harmful or unwanted effects of Sprycel, please share your experience. This could help to raise awareness about Sprycel side effects, identify uknown risks and inform health professionals and patients taking Sprycel.

Examples: headache, dizziness


The most commonly reported Sprycel side effects are:
Bone Pain (9 reports)
Acne (8 reports)
Boils (6 reports)
Pimples (6 reports)
Plueral Effusion (5 reports)
Arthritis (3 reports)
Boils, Pimples (3 reports)
Myalgia (2 reports)
Nausea (2 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Sprycel side effects . You can also compare Sprycel side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Traumatic Haemothorax, Pleural Effusion
on Mar 11, 2014 Male from MX , 39 years of age, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: traumatic haemothorax, pleural effusion. Sprycel dosage: N/A. Patient was hospitalized.

Skin Reaction
Patient was taking Sprycel. Patient felt the following Sprycel side effects: skin reaction on Mar 27, 2014 from ES Additional patient health information: Male , 58 years of age, . Sprycel dosage: N/A.

Multi-organ Failure, Hyperkalaemia, Upper Gastrointestinal Haemorrhage, Myocardial Infarction, Platelet Count Decreased
Adverse event was reported on Feb 24, 2014 by a Male taking Sprycel (Dosage: Total No. Of Course:6?last Dose:07jan2014) was diagnosed with and. Location: US , 71 years of age, weighting 205.0 lb, After Sprycel was administered, patient encountered several Sprycel side effects: multi-organ failure, hyperkalaemia, upper gastrointestinal haemorrhage, myocardial infarction, platelet count decreased.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Angioedema, Pleural Effusion, Hypersensitivity, Uvulitis
on Feb 04, 2014 Female from ES , 83 years of age, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: angioedema, pleural effusion, hypersensitivity, uvulitis. Sprycel dosage: Restarted At A Dose Of 40 Mg/day..
Associated medications used: Patient was hospitalized.


Rash, Pericardial Effusion
on Feb 03, 2014 Female from US , 59 years of age, was treated with Sprycel. Patient felt the following Sprycel side effects: rash, pericardial effusion. Sprycel dosage: N/A.

Prostatic Disorder, Haemothorax, Diarrhoea
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: prostatic disorder, haemothorax, diarrhoea on Feb 03, 2014 from US Additional patient health information: Male , 76 years of age, weighting 209.0 lb, was diagnosed with and. Sprycel dosage: Dose Reduced To 50 Mg.
Multiple concurrent drugs taken:
  • Metoprolol
  • Folic Acid
  • Allopurinol
  • Quinapril
  • Potassium Citrate
  • Lovaza (2 Caps)
  • Aspirin
  • Lipitor
Patient was hospitalized.

Lymphoplasmacytoid Lymphoma/immunocytoma, Asthenia, Nasopharyngitis
Adverse event was reported on Mar 18, 2014 by a Female taking Sprycel (cml) Tabs 100 Mg (Dosage: N/A) was diagnosed with and. Location: FR , 60 years of age, Directly after, patient experienced the unwanted or unexpected Sprycel side effects: lymphoplasmacytoid lymphoma/immunocytoma, asthenia, nasopharyngitis. Patient was hospitalized.

Adverse Event
on Jan 30, 2014 Male from CO , 29 years of age, was diagnosed with and was treated with Sprycel (ph+all) Tabs 70 Mg. Patient felt the following Sprycel side effects: adverse event. Sprycel (ph+all) Tabs 70 Mg dosage: N/A. Patient was hospitalized.

Sepsis, Multi-organ Failure, Gastrointestinal Haemorrhage, Hepatic Failure, Renal Failure Acute, Hypernatraemia, Disseminated Intravascular Coagulation, Hyperglycaemia, Febrile Neutropenia
on Jan 29, 2014 Male from JP , 63 years of age, weighting 132.5 lb, was diagnosed with and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: sepsis, multi-organ failure, gastrointestinal haemorrhage, hepatic failure, renal failure acute, hypernatraemia, disseminated intravascular coagulation, hyperglycaemia, febrile neutropenia. 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..
Multiple concurrent drugs taken:
  • 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
Patient was hospitalized.


Patient was taking Sprycel. on Jan 28, 2014 from US Additional patient health information: Male , 70 years of age, . Sprycel dosage: Tabs.

Cardiac Failure
Adverse event was reported on Feb 24, 2014 by a Female taking Sprycel (Dosage: N/A) was diagnosed with and. Location: JP , 81 years of age, weighting 123.5 lb, Patient felt the following Sprycel side effects: cardiac failure.
Multiple prescriptions taken:

Pulmonary Oedema
on Jan 17, 2014 Male from US , 68 years of age, was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: pulmonary oedema. Sprycel dosage: N/A.
Multiple concurrent drugs taken:
  • Lumigan
  • Clobetasol
  • Carvedilol
  • Pravastatin
  • Lantus
  • Losartan Hctz
  • Furosemide
  • Tylenol
Patient was hospitalized.

Abortion Spontaneous, Pregnancy
on Feb 20, 2014 Female from JP , 27 years of age, weighting 125.7 lb, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: abortion spontaneous, pregnancy. Sprycel dosage: N/A.

Malignant Neoplasm Progression, Shock Haemorrhagic, Thrombocytopenia, Pleural Effusion, Full Blood Count Decreased, Decreased Appetite, Tardive Dyskinesia
Patient was taking Sprycel (ph+all) Tabs. Patient felt the following Sprycel side effects: malignant neoplasm progression, shock haemorrhagic, thrombocytopenia, pleural effusion, full blood count decreased, decreased appetite, tardive dyskinesia on Feb 07, 2014 from US Additional patient health information: Female , 66 years of age, was diagnosed with and. Sprycel (ph+all) Tabs dosage: N/A.
Multiple prescriptions taken: Patient was hospitalized.

Nervous System Disorder
Adverse event was reported on Jan 21, 2014 by a Male taking Sprycel (Dosage: N/A) was diagnosed with and. Location: IT , 50 years of age, After Sprycel was administered, patient encountered several Sprycel side effects: nervous system disorder. Patient was hospitalized.

Cardiac Failure, Stress Cardiomyopathy, Sepsis, Pleural Effusion
on Mar 11, 2014 Female from JP , 68 years of age, was diagnosed with and was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: cardiac failure, stress cardiomyopathy, sepsis, pleural effusion. Sprycel dosage: N/A. Patient was hospitalized.

Basal Cell Carcinoma, Squamous Cell Carcinoma, Hyperkeratosis, Dry Skin, Eczema, Rash Macular, Fatigue
on Jan 09, 2014 Male from AU , 60 years of age, was diagnosed with and was treated with Sprycel (cml) Tabs 100 Mg. Patient felt the following Sprycel side effects: basal cell carcinoma, squamous cell carcinoma, hyperkeratosis, dry skin, eczema, rash macular, fatigue. Sprycel (cml) Tabs 100 Mg dosage: Halving The Dose For 7 Days.

Adenocarcinoma Pancreas
Patient was taking Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: adenocarcinoma pancreas on Jan 08, 2014 from FR Additional patient health information: Male , 67 years of age, . Sprycel dosage: N/A. Patient was hospitalized.

Acute Myocardial Infarction, Left Ventricular Dysfunction
Adverse event was reported on Jan 07, 2014 by a Male taking Sprycel (Dosage: N/A) was diagnosed with and. Location: GB , 70 years of age, Directly after, patient experienced the unwanted or unexpected Sprycel side effects: acute myocardial infarction, left ventricular dysfunction. Patient was hospitalized.

Malignant Neoplasm Progression
on Jan 30, 2014 Male from IN , 67 years of age, was diagnosed with and was treated with Sprycel. Patient felt the following Sprycel side effects: malignant neoplasm progression. Sprycel dosage: N/A.

Gamma-glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased
on Jan 07, 2014 Male from JP , 83 years of age, weighting 122.1 lb, was diagnosed with and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: gamma-glutamyltransferase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased. Sprycel dosage: 70mg:30jun09-21jul09?70mg:28jul09-10sep09?50mg:15oct09 -ong.
Multiple concurrent drugs taken:
  • Zyloric (Initial Dose:stop Date 10nov2009(tablet)?2nd Dose:start Date 11nov2009(oral)(tablet))
  • Potassium Aspartate


Fatigue, White Blood Cell Count Decreased
Patient was taking Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: fatigue, white blood cell count decreased on Jan 03, 2014 from US Additional patient health information: Female , 70 years of age, was diagnosed with and. Sprycel dosage: N/A. Patient was hospitalized.

Cardiac Arrest, Pneumothorax, Fluid Retention
Adverse event was reported on Feb 26, 2014 by a Female taking Sprycel (Dosage: N/A) was diagnosed with and. Location: US , 71 years of age, Patient felt the following Sprycel side effects: cardiac arrest, pneumothorax, fluid retention.
Multiple prescriptions taken:
  • Lasix
  • Diltiazem Hcl
  • Potassium
  • Diamox
  • Singulair
  • Elavil
  • Prilosec (1df= 1 Capsule.?20mg)
  • Temodar
Patient was hospitalized.

Chylothorax
on Jan 10, 2014 Female from SE , 58 years of age, was diagnosed with and was treated with Sprycel. After Sprycel was administered, patient encountered several Sprycel side effects: chylothorax. Sprycel dosage: 70mg 11mar13-14may13,50mg 15may13-12jun13.
Multiple concurrent drugs taken: Patient was hospitalized.

Cardiac Arrest
on Dec 30, 2013 Female from US , 47 years of age, was treated with Sprycel. Directly after, patient experienced the unwanted or unexpected Sprycel side effects: cardiac arrest. Sprycel dosage: N/A. Patient was hospitalized.

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Record and Track Your Side Effects

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.

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JustAnswer.com

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]

Latest Sprycel clinical trials