How are Decitabine adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Decitabine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Decitabine is flagged as the suspect drug causing the adverse event.
What are the most common Decitabine adverse events reported to the FDA?
Febrile Neutropenia | 251 (3.62%) |
Pneumonia | 139 (2%) |
Haemoglobin Decreased | 110 (1.59%) |
Neutropenia | 108 (1.56%) |
Pyrexia | 107 (1.54%) |
Nausea | 104 (1.5%) |
Thrombocytopenia | 101 (1.46%) |
White Blood Cell Count Decreased | 82 (1.18%) |
Anaemia | 75 (1.08%) |
Platelet Count Decreased | 72 (1.04%) |
Vomiting | 72 (1.04%) |
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This graph shows the top adverse events submitted to the FDA for Decitabine, 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 Decitabine 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.
What are the most common Decitabine adverse events reported to the FDA?
Infections - Pathogen Unspecified | 635 (9.16%) |
Hematology Investigations | 396 (5.71%) |
White Blood Cell | 391 (5.64%) |
Bacterial Infectious | 357 (5.15%) |
Respiratory | 322 (4.64%) |
Gastrointestinal Signs | 273 (3.94%) |
Neurological | 179 (2.58%) |
Lower Respiratory Tract Disorders | 157 (2.26%) |
Anemias Nonhemolytic And Marrow Dep... | 142 (2.05%) |
Cardiac Arrhythmias | 122 (1.76%) |
Gastrointestinal Motility And Defec... | 122 (1.76%) |
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This graph shows the top categories of adverse events submitted to the FDA for Decitabine, 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 Decitabine 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.
Why are people taking Decitabine, according to those reporting adverse events to the FDA?
Acute Myeloid Leukaemia | 411 |
Myelodysplastic Syndrome | 403 |
Drug Use For Unknown Indication | 17 |
Chronic Myelomonocytic Leukaemia | 17 |
Ovarian Cancer | 13 |
Metastatic Malignant Melanoma | 11 |
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Label | Labeler | Effective |
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Dacogen | Eisai Inc. | 30-MAR-10 |
What Decitabine safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Decitabine. 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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