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Bleomycin Adverse Events Reported to the FDA Over Time

How are Bleomycin adverse event reports trending over time?

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

Most Common Bleomycin Adverse Events Reported to the FDA

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

Febrile Neutropenia
185 (2.49%)
Pulmonary Toxicity
155 (2.09%)
Pyrexia
152 (2.05%)
Neutropenia
122 (1.64%)
Interstitial Lung Disease
97 (1.31%)
Anaemia
94 (1.27%)
Thrombocytopenia
94 (1.27%)
Dyspnoea
89 (1.2%)
Sepsis
87 (1.17%)
Vomiting
76 (1.02%)
Nausea
75 (1.01%)
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Pulmonary Fibrosis
75 (1.01%)
Mucosal Inflammation
72 (.97%)
Pulmonary Embolism
67 (.9%)
Pneumocystis Jiroveci Pneumonia
65 (.87%)
Metastasis
64 (.86%)
Pancytopenia
64 (.86%)
Acute Myeloid Leukaemia
62 (.83%)
Deep Vein Thrombosis
62 (.83%)
Renal Failure Acute
57 (.77%)
Infection
56 (.75%)
Diarrhoea
55 (.74%)
Septic Shock
54 (.73%)
Respiratory Failure
53 (.71%)
Myelodysplastic Syndrome
50 (.67%)
Leukopenia
49 (.66%)
Bone Marrow Failure
47 (.63%)
Pneumonitis
46 (.62%)
Chills
45 (.61%)
Osteonecrosis
44 (.59%)
Acute Respiratory Distress Syndrome
43 (.58%)
Death
42 (.57%)
White Blood Cell Count Decreased
40 (.54%)
Pneumonia
39 (.52%)
Respiratory Disorder
39 (.52%)
Drug Toxicity
38 (.51%)
Hypotension
37 (.5%)
Lung Infiltration
37 (.5%)
Hypoxia
35 (.47%)
Lung Disorder
35 (.47%)
Myocardial Infarction
35 (.47%)
Asthenia
34 (.46%)
Febrile Bone Marrow Aplasia
32 (.43%)
Cerebral Infarction
31 (.42%)
Cough
31 (.42%)
Herpes Zoster
31 (.42%)
Convulsion
30 (.4%)
Hypothyroidism
30 (.4%)
Neutropenic Sepsis
30 (.4%)
Headache
29 (.39%)
Malignant Neoplasm Progression
28 (.38%)
Multi-organ Failure
27 (.36%)
Haemoglobin Decreased
26 (.35%)
Hyponatraemia
26 (.35%)
Neurotoxicity
26 (.35%)
Tachycardia
26 (.35%)
Progressive Multifocal Leukoencepha...
24 (.32%)
Dermatitis
23 (.31%)
Cardiac Failure
22 (.3%)
Carotid Artery Thrombosis
22 (.3%)
Disease Progression
22 (.3%)
Encephalopathy
22 (.3%)
Fatigue
22 (.3%)
Renal Failure
22 (.3%)
Pulmonary Haemorrhage
21 (.28%)
Thrombosis
21 (.28%)
Abdominal Pain
20 (.27%)
Cerebrovascular Accident
20 (.27%)
General Physical Health Deteriorati...
20 (.27%)
Haemorrhage
20 (.27%)
Oedema Peripheral
20 (.27%)
Pneumothorax
20 (.27%)
Polyneuropathy
20 (.27%)
Dehydration
19 (.26%)
Respiratory Distress
19 (.26%)
Treatment Related Secondary Maligna...
19 (.26%)
Cardiac Arrest
18 (.24%)
Haematotoxicity
18 (.24%)
Hepatotoxicity
18 (.24%)
Neuropathy Peripheral
18 (.24%)
Off Label Use
18 (.24%)
Pneumomediastinum
18 (.24%)
Acute Promyelocytic Leukaemia
17 (.23%)
Agranulocytosis
17 (.23%)
Arthralgia
17 (.23%)
Cytomegalovirus Infection
17 (.23%)
Platelet Count Decreased
17 (.23%)
Pregnancy
17 (.23%)
Arterial Thrombosis
16 (.22%)
Blood Creatinine Increased
16 (.22%)
Dysphagia
16 (.22%)
Gastrointestinal Haemorrhage
16 (.22%)
Groin Pain
16 (.22%)
Lung Infection
16 (.22%)
Subcutaneous Emphysema
16 (.22%)
Confusional State
15 (.2%)
Disseminated Intravascular Coagulat...
15 (.2%)
Hepatitis B
15 (.2%)
Loss Of Consciousness
15 (.2%)
Neoplasm Malignant
15 (.2%)
Neutrophil Count Decreased
15 (.2%)

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

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

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

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

Hodgkins Disease
915
Testis Cancer
254
Germ Cell Cancer
122
Non-hodgkins Lymphoma
102
T-cell Lymphoma
94
Diffuse Large B-cell Lymphoma
83
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Testicular Germ Cell Cancer
67
Lymphoma
58
Product Used For Unknown Indication
34
Seminoma
34
B-cell Lymphoma
31
Chemotherapy
28
Ovarian Cancer
28
Peripheral T-cell Lymphoma Unspecif...
27
Ovarian Germ Cell Cancer
22
Drug Use For Unknown Indication
21
Testicular Seminoma (pure)
20
Cervix Carcinoma
18
Testicular Neoplasm
15
Craniopharyngioma
14
Kaposis Sarcoma
14
Penis Carcinoma
14
Testicular Cancer Metastatic
13
Yolk Sac Tumour Site Unspecified
12
Hodgkins Disease Stage Ii
11
Choriocarcinoma
11
Hodgkins Disease Stage Iv
11
Sarcoma
11
Ewings Sarcoma
11
Ovarian Neoplasm
10
Pseudolymphoma
10
Malignant Lymphoid Neoplasm
10
Teratoma Of Testis
9
Non-hodgkins Lymphoma Stage Iv
9
Hodgkins Disease Nodular Sclerosis ...
9
Bone Sarcoma
9
Hodgkins Disease Stage Iii
8
Teratoma
8
Anaplastic Large Cell Lymphoma T- A...
7
Testicular Embryonal Carcinoma
7
Burkitts Lymphoma
7
Squamous Cell Carcinoma Of The Cerv...
6
Pituitary Tumour
6
Kaposis Sarcoma Aids Related
6
Neoplasm
6
Multiple Myeloma
5
Mantle Cell Lymphoma
5
Malignant Mediastinal Neoplasm
5
Ovarian Germ Cell Endodermal Sinus ...
5
Testicular Germ Cell Tumour Mixed S...
5
Mycosis Fungoides
5

Drug Labels

LabelLabelerEffective
BleomycinBedford Laboratories22-OCT-09
BleomycinAPP Pharmaceuticals, LLC06-JUL-11
BleomycinHospira Worldwide, Inc.07-AUG-12
BleomycinTeva Parenteral Medicines, Inc.04-APR-13

Bleomycin Case Reports

What Bleomycin 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 Bleomycin. 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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