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MITOXANTRONE

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Mitoxantrone Adverse Events Reported to the FDA Over Time

How are Mitoxantrone adverse event reports trending over time?

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

Most Common Mitoxantrone Adverse Events Reported to the FDA

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

Febrile Neutropenia
278 (2.34%)
Neutropenia
212 (1.79%)
Acute Myeloid Leukaemia
204 (1.72%)
Ejection Fraction Decreased
195 (1.64%)
Acute Promyelocytic Leukaemia
158 (1.33%)
Pyrexia
145 (1.22%)
White Blood Cell Count Decreased
133 (1.12%)
Pneumonia
124 (1.04%)
Myelodysplastic Syndrome
114 (.96%)
Sepsis
112 (.94%)
Pancytopenia
106 (.89%)
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Cardiac Failure Congestive
103 (.87%)
Anaemia
99 (.83%)
Thrombocytopenia
98 (.83%)
Cardiomyopathy
96 (.81%)
Platelet Count Decreased
96 (.81%)
Nausea
90 (.76%)
Dyspnoea
84 (.71%)
Acute Leukaemia
81 (.68%)
Infection
81 (.68%)
Hypotension
80 (.67%)
Diarrhoea
79 (.67%)
Septic Shock
79 (.67%)
Respiratory Failure
73 (.62%)
Haemoglobin Decreased
71 (.6%)
Vomiting
71 (.6%)
Multi-organ Failure
69 (.58%)
Condition Aggravated
68 (.57%)
Mucosal Inflammation
68 (.57%)
Myocardial Infarction
65 (.55%)
Fatigue
64 (.54%)
Cardiac Failure
63 (.53%)
Leukaemia
61 (.51%)
Asthenia
60 (.51%)
Pleural Effusion
60 (.51%)
Cardiac Disorder
58 (.49%)
Leukopenia
56 (.47%)
Neutrophil Count Decreased
54 (.46%)
Dehydration
52 (.44%)
Death
49 (.41%)
Chills
47 (.4%)
Disseminated Intravascular Coagulat...
47 (.4%)
Convulsion
46 (.39%)
Disease Progression
46 (.39%)
Renal Failure Acute
46 (.39%)
Headache
45 (.38%)
Oedema Peripheral
45 (.38%)
Bronchopulmonary Aspergillosis
44 (.37%)
Chest Pain
43 (.36%)
Renal Failure
43 (.36%)
Acute Respiratory Distress Syndrome
42 (.35%)
Deep Vein Thrombosis
42 (.35%)
General Physical Health Deteriorati...
42 (.35%)
Staphylococcal Infection
42 (.35%)
Bone Marrow Failure
41 (.35%)
Gastrointestinal Haemorrhage
41 (.35%)
Confusional State
40 (.34%)
Cardiotoxicity
37 (.31%)
Cerebral Haemorrhage
37 (.31%)
Fall
35 (.29%)
Hypokalaemia
35 (.29%)
Stomatitis
35 (.29%)
Urinary Tract Infection
35 (.29%)
Cardiac Arrest
34 (.29%)
Hepatic Function Abnormal
34 (.29%)
Cellulitis
33 (.28%)
Drug Toxicity
33 (.28%)
Pain
33 (.28%)
Heart Rate Increased
32 (.27%)
Multiple Sclerosis
32 (.27%)
Renal Impairment
32 (.27%)
Syncope
32 (.27%)
Cardiomegaly
31 (.26%)
Fungal Infection
31 (.26%)
Abdominal Pain
30 (.25%)
Cardio-respiratory Arrest
30 (.25%)
Multiple Sclerosis Relapse
30 (.25%)
Respiratory Distress
30 (.25%)
Weight Decreased
30 (.25%)
Hepatic Failure
29 (.24%)
Blood Culture Positive
28 (.24%)
Red Blood Cell Count Decreased
28 (.24%)
Drug Ineffective
27 (.23%)
Lung Infiltration
27 (.23%)
Malignant Neoplasm Progression
27 (.23%)
Coma
26 (.22%)
Dysphagia
26 (.22%)
Hepatitis B
26 (.22%)
Hypertension
26 (.22%)
Lung Infection
25 (.21%)
Malaise
25 (.21%)
Tachycardia
25 (.21%)
Anorexia
24 (.2%)
Arrhythmia
24 (.2%)
Congestive Cardiomyopathy
24 (.2%)
Enterococcal Infection
24 (.2%)
Mitral Valve Incompetence
24 (.2%)
Neutropenic Sepsis
24 (.2%)
Pulmonary Oedema
24 (.2%)
Atrial Fibrillation
23 (.19%)
Blood Lactate Dehydrogenase Increas...
23 (.19%)

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

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

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

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

Multiple Sclerosis
1150
Acute Myeloid Leukaemia
533
Non-hodgkins Lymphoma
172
B-cell Lymphoma
154
Prostate Cancer
98
Prostate Cancer Metastatic
84
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Acute Promyelocytic Leukaemia
83
Secondary Progressive Multiple Scle...
80
Lymphoma
80
Chronic Lymphocytic Leukaemia
69
Acute Lymphocytic Leukaemia
57
Relapsing-remitting Multiple Sclero...
53
Acute Myeloid Leukaemia Recurrent
47
Product Used For Unknown Indication
46
Breast Cancer
44
Drug Use For Unknown Indication
41
Diffuse Large B-cell Lymphoma
32
Mantle Cell Lymphoma
23
Chemotherapy
20
Acute Leukaemia
15
Breast Cancer Metastatic
14
Neoplasm Malignant
12
Non-hodgkins Lymphoma Recurrent
12
Immunosuppression
11
Myelodysplastic Syndrome
11
Progressive Multiple Sclerosis
10
T-cell Prolymphocytic Leukaemia
10
Acute Lymphocytic Leukaemia Recurre...
10
Chronic Myeloid Leukaemia
10
Off Label Use
10
Leukaemia
9
Myeloid Leukaemia
9
B Precursor Type Acute Leukaemia
8
Acute Myelomonocytic Leukaemia
7
Acute Monocytic Leukaemia
6
Primary Progressive Multiple Sclero...
6
Peripheral T-cell Lymphoma Unspecif...
6
Leukaemia Recurrent
6
Non-hodgkins Lymphoma Unspecified H...
6
Diffuse Large B-cell Lymphoma Stage...
5
Neuromyelitis Optica
5
Langerhans Cell Granulomatosis
5
Disease Progression
5
Chloroma
4
Breast Cancer Female
4
Bone Pain
4
Drug Exposure During Pregnancy
4
Multiple Sclerosis Relapse
4
Follicle Centre Lymphoma, Follicula...
4
Multiple Myeloma
3
Mantle Cell Lymphoma Stage Iv
3

Drug Labels

LabelLabelerEffective
MitoxantroneAPP Pharmaceuticals, LLC05-MAY-11
MitoxantroneTeva Parenteral Medicines, Inc15-JUN-12
MitoxantroneHospira Worldwide, Inc.19-JUN-12
MitoxantroneBedford Laboratories04-DEC-12

Mitoxantrone Case Reports

What Mitoxantrone 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 Mitoxantrone. 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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