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Sprycel Adverse Events Reported to the FDA Over Time

How are Sprycel adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Sprycel, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Sprycel is flagged as the suspect drug causing the adverse event.

Most Common Sprycel Adverse Events Reported to the FDA

What are the most common Sprycel adverse events reported to the FDA?

Pleural Effusion
551 (5.47%)
Anaemia
206 (2.04%)
Death
201 (1.99%)
Diarrhoea
200 (1.98%)
Platelet Count Decreased
195 (1.94%)
Nausea
173 (1.72%)
Headache
172 (1.71%)
Dyspnoea
155 (1.54%)
White Blood Cell Count Decreased
153 (1.52%)
Pyrexia
142 (1.41%)
Rash
135 (1.34%)
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Fatigue
129 (1.28%)
Pneumonia
110 (1.09%)
Neoplasm Malignant
108 (1.07%)
Gastrointestinal Haemorrhage
105 (1.04%)
Neutrophil Count Decreased
103 (1.02%)
Vomiting
100 (.99%)
Thrombocytopenia
99 (.98%)
Malignant Neoplasm Progression
98 (.97%)
Pancytopenia
78 (.77%)
Decreased Appetite
77 (.76%)
Sepsis
77 (.76%)
Generalised Oedema
74 (.73%)
Pulmonary Oedema
74 (.73%)
Dehydration
72 (.71%)
Pericardial Effusion
69 (.68%)
Interstitial Lung Disease
65 (.65%)
Renal Failure
64 (.64%)
Cardiac Failure
60 (.6%)
Fluid Retention
60 (.6%)
Cardiac Failure Congestive
56 (.56%)
Haemoglobin Decreased
56 (.56%)
Myalgia
56 (.56%)
Abdominal Pain
55 (.55%)
Cough
53 (.53%)
Respiratory Failure
53 (.53%)
Oedema Peripheral
51 (.51%)
Weight Increased
51 (.51%)
Febrile Neutropenia
48 (.48%)
Oedema
48 (.48%)
Pulmonary Haemorrhage
46 (.46%)
Adverse Event
43 (.43%)
Asthenia
43 (.43%)
Alanine Aminotransferase Increased
42 (.42%)
Atrial Fibrillation
39 (.39%)
Neutropenia
39 (.39%)
Weight Decreased
39 (.39%)
Dizziness
38 (.38%)
Arthralgia
37 (.37%)
Blood Creatinine Increased
36 (.36%)
Hypokalaemia
36 (.36%)
Multi-organ Failure
36 (.36%)
Drug Ineffective
35 (.35%)
Ascites
33 (.33%)
Pruritus
33 (.33%)
Constipation
32 (.32%)
Haemorrhage
32 (.32%)
Malaise
32 (.32%)
Pain
32 (.32%)
Pregnancy
32 (.32%)
Pulmonary Embolism
32 (.32%)
Confusional State
31 (.31%)
Hypertension
31 (.31%)
Cerebral Haemorrhage
29 (.29%)
Pulmonary Arterial Hypertension
29 (.29%)
Renal Failure Acute
29 (.29%)
Aspartate Aminotransferase Increase...
28 (.28%)
Chest Pain
28 (.28%)
Colitis
28 (.28%)
Gastrointestinal Disorder
28 (.28%)
Hypotension
28 (.28%)
Disseminated Intravascular Coagulat...
27 (.27%)
Liver Disorder
27 (.27%)
Electrocardiogram Qt Prolonged
26 (.26%)
Hepatomegaly
26 (.26%)
Pulmonary Hypertension
26 (.26%)
Infection
25 (.25%)
White Blood Cell Count Increased
25 (.25%)
Lung Disorder
23 (.23%)
Pleurisy
23 (.23%)
Tumour Lysis Syndrome
23 (.23%)
Bone Pain
22 (.22%)
Chest Discomfort
22 (.22%)
Depression
22 (.22%)
Hepatotoxicity
22 (.22%)
Lung Infiltration
22 (.22%)
Anxiety
21 (.21%)
Bone Marrow Failure
21 (.21%)
Drug Interaction
21 (.21%)
Myocardial Infarction
21 (.21%)
Cerebrovascular Accident
20 (.2%)
Chills
20 (.2%)
Convulsion
20 (.2%)
Red Blood Cell Count Decreased
20 (.2%)
Blood Bilirubin Increased
19 (.19%)
Cardiac Disorder
19 (.19%)
Hepatic Enzyme Increased
19 (.19%)
Hyperuricaemia
19 (.19%)
Respiratory Disorder
19 (.19%)
Blood Alkaline Phosphatase Increase...
18 (.18%)
Blood Glucose Increased
18 (.18%)

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This graph shows the top adverse events submitted to the FDA for Sprycel, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sprycel is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Sprycel

What are the most common Sprycel adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Sprycel, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sprycel is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Sprycel According to Those Reporting Adverse Events

Why are people taking Sprycel, according to those reporting adverse events to the FDA?

Chronic Myeloid Leukaemia
1542
Acute Lymphocytic Leukaemia
346
Leukaemia
60
Acute Myeloid Leukaemia
49
Blast Crisis In Myelogenous Leukaem...
24
Acute Lymphocytic Leukaemia Recurre...
19
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B Precursor Type Acute Leukaemia
16
Chromosome Analysis Abnormal
15
Ovarian Epithelial Cancer
11
Breast Cancer Metastatic
9
Glioblastoma Multiforme
7
Gastrointestinal Stromal Tumour
7
Hepatic Neoplasm Malignant
7
Lung Adenocarcinoma
7
Mastocytosis
6
Lymphocytic Leukaemia
5
Neoplasm Malignant
5
Myelodysplastic Syndrome
4
Non-hodgkins Lymphoma
4
Adenoid Cystic Carcinoma
4
Prostate Cancer
4
Chronic Leukaemia
4
Salivary Gland Cancer
3
Malignant Soft Tissue Neoplasm
3
Blast Cell Proliferation
3
Retroperitoneal Cancer
3
Acute Leukaemia
3
Chronic Lymphocytic Leukaemia
3
Adenocarcinoma Pancreas
3
Chronic Myeloid Leukaemia Transform...
3
Polycythaemia Vera
3
Neoplasm
3
Systemic Mastocytosis
3
Myeloid Leukaemia
3
Ovarian Cancer
2
Lung Neoplasm Malignant
2
Gastrointestinal Carcinoma
2
Chronic Myelomonocytic Leukaemia
2
Ewings Sarcoma
2
Tongue Neoplasm Malignant Stage Uns...
2
Malignant Melanoma
2
Product Used For Unknown Indication
2
Sarcoma
2
Metastatic Renal Cell Carcinoma
2
Malignant Nipple Neoplasm
1
Pancreatic Carcinoma
1
Metastatic Malignant Melanoma
1
Myeloproliferative Disorder
1
Breast Cancer
1
Small Cell Lung Cancer Stage Unspec...
1
Gastric Cancer
1

Drug Labels

LabelLabelerEffective
Sprycel Physicians Total Care, Inc.01-JUN-12
SprycelE.R. Squibb & Sons, L.L.C.01-NOV-12

Sprycel Case Reports

What Sprycel safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Sprycel. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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