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MYLOTARG

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Mylotarg Adverse Events Reported to the FDA Over Time

How are Mylotarg adverse event reports trending over time?

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

Most Common Mylotarg Adverse Events Reported to the FDA

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

Febrile Neutropenia
422 (3.52%)
Platelet Count Decreased
421 (3.51%)
Sepsis
310 (2.59%)
White Blood Cell Count Decreased
303 (2.53%)
Neutrophil Count Decreased
284 (2.37%)
Aspartate Aminotransferase Increase...
235 (1.96%)
Pyrexia
229 (1.91%)
Anaemia
227 (1.9%)
Pneumonia
220 (1.84%)
Blood Alkaline Phosphatase Increase...
184 (1.54%)
Alanine Aminotransferase Increased
175 (1.46%)
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Disseminated Intravascular Coagulat...
174 (1.45%)
Blood Bilirubin Increased
171 (1.43%)
Venoocclusive Liver Disease
162 (1.35%)
Chills
152 (1.27%)
Blood Lactate Dehydrogenase Increas...
147 (1.23%)
Haemoglobin Decreased
147 (1.23%)
Condition Aggravated
145 (1.21%)
Neutropenia
138 (1.15%)
Weight Increased
129 (1.08%)
Disease Progression
128 (1.07%)
Acute Myeloid Leukaemia
117 (.98%)
Infusion Related Reaction
116 (.97%)
Hypotension
110 (.92%)
Pleural Effusion
104 (.87%)
Ascites
99 (.83%)
Thrombocytopenia
98 (.82%)
Hypokalaemia
92 (.77%)
Hepatic Function Abnormal
88 (.73%)
Dyspnoea
87 (.73%)
Septic Shock
82 (.68%)
Nausea
81 (.68%)
Haematocrit Decreased
78 (.65%)
Malignant Neoplasm Progression
77 (.64%)
Pancytopenia
76 (.63%)
C-reactive Protein Increased
75 (.63%)
Liver Disorder
72 (.6%)
Diarrhoea
66 (.55%)
Multi-organ Failure
61 (.51%)
Renal Failure
60 (.5%)
Renal Failure Acute
59 (.49%)
Gamma-glutamyltransferase Increased
58 (.48%)
Hepatomegaly
58 (.48%)
Fibrin Degradation Products Increas...
57 (.48%)
Blood Urea Increased
56 (.47%)
Respiratory Failure
53 (.44%)
Blood Creatinine Increased
52 (.43%)
Renal Impairment
52 (.43%)
Gastrointestinal Haemorrhage
51 (.43%)
Vomiting
50 (.42%)
Performance Status Decreased
49 (.41%)
Hypoalbuminaemia
47 (.39%)
Acute Respiratory Distress Syndrome
46 (.38%)
Hypoxia
46 (.38%)
Cerebral Haemorrhage
45 (.38%)
Tumour Lysis Syndrome
45 (.38%)
Epistaxis
44 (.37%)
Fatigue
42 (.35%)
Hypertension
42 (.35%)
Infection
42 (.35%)
Blood Potassium Decreased
41 (.34%)
Red Blood Cell Count Decreased
41 (.34%)
Anorexia
39 (.33%)
Blast Cell Count Increased
38 (.32%)
Cellulitis
38 (.32%)
Pulmonary Oedema
37 (.31%)
Respiratory Distress
36 (.3%)
Stomatitis
36 (.3%)
Hyperbilirubinaemia
35 (.29%)
Oedema
35 (.29%)
General Physical Health Deteriorati...
33 (.28%)
Tachycardia
33 (.28%)
Blood Culture Positive
32 (.27%)
Blood Albumin Decreased
31 (.26%)
Abdominal Distension
30 (.25%)
Herpes Simplex
30 (.25%)
Lung Infiltration
30 (.25%)
Malaise
30 (.25%)
Cardiac Failure Congestive
29 (.24%)
Interstitial Lung Disease
29 (.24%)
Bacteraemia
28 (.23%)
Cardiac Failure
28 (.23%)
Hepatic Failure
28 (.23%)
Body Temperature Increased
27 (.23%)
Pulmonary Haemorrhage
27 (.23%)
Drug Ineffective
26 (.22%)
Headache
26 (.22%)
Abdominal Pain
25 (.21%)
Bacterial Infection
25 (.21%)
Chest Pain
24 (.2%)
Hypoproteinaemia
24 (.2%)
Liver Function Test Abnormal
24 (.2%)
Staphylococcal Infection
24 (.2%)
White Blood Cell Count Increased
24 (.2%)
Asthenia
23 (.19%)
Blood Pressure Decreased
23 (.19%)
Herpes Zoster
23 (.19%)
Bone Marrow Failure
22 (.18%)
Bronchopulmonary Aspergillosis
22 (.18%)
Enterococcal Infection
22 (.18%)
Pericardial Effusion
22 (.18%)

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This graph shows the top adverse events submitted to the FDA for Mylotarg, 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 Mylotarg 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 Mylotarg

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

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This graph shows the top categories of adverse events submitted to the FDA for Mylotarg, 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 Mylotarg 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 Mylotarg According to Those Reporting Adverse Events

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

Acute Myeloid Leukaemia
1271
Acute Myeloid Leukaemia Recurrent
352
Myelodysplastic Syndrome
43
Acute Leukaemia
29
Acute Promyelocytic Leukaemia
14
Leukaemia
11
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Drug Use For Unknown Indication
9
Leukaemia Recurrent
8
Acute Lymphocytic Leukaemia
7
Myeloid Leukaemia
7
Product Used For Unknown Indication
6
T-cell Type Acute Leukaemia
5
Disease Recurrence
3
Non-hodgkins Lymphoma
3
Chronic Myeloid Leukaemia
2
Autologous Bone Marrow Transplantat...
1
Hiv Infection
1
Refractory Anaemia
1
Atrial Fibrillation
1
Chemotherapy
1
Chloroma
1
Myeloproliferative Disorder
1
Premedication
1

Drug Labels

LabelLabelerEffective
MylotargWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.19-APR-10

Mylotarg Case Reports

What Mylotarg 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 Mylotarg. 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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