DOXORUBICIN
Doxorubicin Adverse Events Reported to the FDA Over Time
How are Doxorubicin adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Doxorubicin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Doxorubicin is flagged as the suspect drug causing the adverse event.
Most Common Doxorubicin Adverse Events Reported to the FDA
What are the most common Doxorubicin adverse events reported to the FDA?
| Febrile Neutropenia | 2247 (2.61%) |
| Neutropenia | 1780 (2.06%) |
| Pyrexia | 1487 (1.72%) |
| Nausea | 1125 (1.3%) |
| Vomiting | 1080 (1.25%) |
| Diarrhoea | 1042 (1.21%) |
| Pneumonia | 1036 (1.2%) |
| Anaemia | 1025 (1.19%) |
| Thrombocytopenia | 856 (.99%) |
| Sepsis | 851 (.99%) |
| Dyspnoea | 842 (.98%) |
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Share/Embed Graph Export Data
This graph shows the top adverse events submitted to the FDA for Doxorubicin, 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 Doxorubicin 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 Doxorubicin
What are the most common Doxorubicin adverse events reported to the FDA?
| Infections - Pathogen Unspecified | 5669 (6.58%) |
| White Blood Cell | 4943 (5.73%) |
| Gastrointestinal Signs | 3325 (3.86%) |
| Hematology Investigations | 3248 (3.77%) |
| Respiratory | 2940 (3.41%) |
| Anemias Nonhemolytic And Marrow Dep... | 2278 (2.64%) |
| Neurological | 2136 (2.48%) |
| Lower Respiratory Tract Disorders | 1999 (2.32%) |
| Electrolyte And Fluid Balance Condi... | 1725 (2%) |
| Epidermal And Dermal Conditions | 1725 (2%) |
| Bacterial Infectious | 1665 (1.93%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Doxorubicin, 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 Doxorubicin 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 Doxorubicin According to Those Reporting Adverse Events
Why are people taking Doxorubicin, according to those reporting adverse events to the FDA?
| Breast Cancer | 3025 |
| Multiple Myeloma | 2728 |
| Diffuse Large B-cell Lymphoma | 2610 |
| Non-hodgkins Lymphoma | 1585 |
| Ovarian Cancer | 1091 |
| Hodgkins Disease | 1054 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Doxorubicin Hydrochloride | Bedford Laboratories | 24-MAR-10 |
| Doxorubicin Hydrochloride | Pfizer Laboratories Div Pfizer Inc | 04-OCT-11 |
| Doxorubicin Hydrochloride | Sun Pharmaceutical Industries Limited | 20-FEB-12 |
| Doxorubicin Hydrochloride | Pfizer Laboratories Div Pfizer Inc. | 15-MAY-12 |
| Adriamycin | Bedford Laboratories | 17-MAY-12 |
| Lipodox | Sun Pharma Global FZE | 22-MAY-12 |
| Lipodox 50 | Sun Pharma Global FZE | 22-MAY-12 |
| Doxorubicin Hydrochloride | Teva Parenteral Medicines, Inc | 13-AUG-12 |
| Doxorubicin Hydrochloride | APP Pharmaceuticals, LLC | 28-AUG-12 |
| Doxil | Janssen Products, LP | 19-SEP-12 |
| Doxorubicin Hydrochloride | Amneal-Agila, LLC | 28-DEC-12 |
| Doxorubicin Hydrochloride | Sun Pharma Global FZE | 05-FEB-13 |
| Doxorubicin Hydrochloride | Pfizer Laboratories Div Pfizer Inc | 06-MAR-13 |
| Doxil | Janssen Products, LP | 12-MAR-13 |
Doxorubicin Case Reports
What Doxorubicin safety concerns are being reported by doctors and researchers in the medical literature?
About Results
This report contains aggregated drug side effects and adverse events for Doxorubicin. 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.
Comments
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