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BLEOMYCIN SULFATE

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Bleomycin Sulfate Adverse Events Reported to the FDA Over Time

How are Bleomycin Sulfate adverse event reports trending over time?

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

Most Common Bleomycin Sulfate Adverse Events Reported to the FDA

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

Febrile Neutropenia
111 (2.57%)
Pulmonary Toxicity
110 (2.55%)
Neutropenia
89 (2.06%)
Pyrexia
86 (1.99%)
Sepsis
62 (1.44%)
Metastasis
60 (1.39%)
Thrombocytopenia
59 (1.37%)
Anaemia
58 (1.34%)
Mucosal Inflammation
50 (1.16%)
Interstitial Lung Disease
47 (1.09%)
Nausea
47 (1.09%)
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Dyspnoea
46 (1.07%)
Septic Shock
45 (1.04%)
Vomiting
45 (1.04%)
Pneumocystis Jiroveci Pneumonia
43 (1%)
Infection
41 (.95%)
Pancytopenia
39 (.9%)
Bone Marrow Failure
37 (.86%)
Pulmonary Embolism
36 (.83%)
Diarrhoea
35 (.81%)
Death
32 (.74%)
Myelodysplastic Syndrome
32 (.74%)
Deep Vein Thrombosis
31 (.72%)
Pulmonary Fibrosis
31 (.72%)
Hypothyroidism
29 (.67%)
Acute Myeloid Leukaemia
28 (.65%)
Chills
28 (.65%)
Myocardial Infarction
28 (.65%)
Leukopenia
27 (.63%)
Respiratory Disorder
27 (.63%)
Cerebral Infarction
26 (.6%)
Herpes Zoster
26 (.6%)
Asthenia
24 (.56%)
Hypotension
24 (.56%)
Lung Infiltration
24 (.56%)
Neurotoxicity
24 (.56%)
Respiratory Failure
23 (.53%)
White Blood Cell Count Decreased
23 (.53%)
Drug Toxicity
22 (.51%)
Pneumonia
22 (.51%)
Dermatitis
21 (.49%)
Acute Respiratory Distress Syndrome
20 (.46%)
Progressive Multifocal Leukoencepha...
20 (.46%)
Neutropenic Sepsis
18 (.42%)
Off Label Use
18 (.42%)
Polyneuropathy
18 (.42%)
Renal Failure Acute
18 (.42%)
Convulsion
17 (.39%)
Pneumonitis
17 (.39%)
Cardiac Failure
16 (.37%)
Febrile Bone Marrow Aplasia
16 (.37%)
Headache
16 (.37%)
Multi-organ Failure
16 (.37%)
Osteonecrosis
16 (.37%)
Thrombosis
16 (.37%)
Neuropathy Peripheral
15 (.35%)
Pneumothorax
15 (.35%)
Renal Failure
15 (.35%)
Abdominal Pain
14 (.32%)
Acute Respiratory Failure
14 (.32%)
Cerebrovascular Accident
14 (.32%)
Haemorrhage
14 (.32%)
Hyponatraemia
14 (.32%)
Pericardial Effusion
14 (.32%)
Pneumomediastinum
14 (.32%)
Tachycardia
14 (.32%)
Arterial Thrombosis
13 (.3%)
Hepatitis B
13 (.3%)
Hypoxia
13 (.3%)
Lung Disorder
13 (.3%)
Neoplasm Malignant
13 (.3%)
Pregnancy
13 (.3%)
Agranulocytosis
12 (.28%)
Aphthous Stomatitis
12 (.28%)
Carotid Artery Thrombosis
12 (.28%)
Cough
12 (.28%)
Malignant Neoplasm Progression
12 (.28%)
Stem Cell Transplant
12 (.28%)
Subcutaneous Emphysema
12 (.28%)
Cardiac Arrest
11 (.25%)
Dehydration
11 (.25%)
Haematotoxicity
11 (.25%)
Haemoglobin Decreased
11 (.25%)
Lung Infection
11 (.25%)
Neutrophil Count Decreased
11 (.25%)
Presyncope
11 (.25%)
Scleroderma
11 (.25%)
Acute Myelomonocytic Leukaemia
10 (.23%)
Blood Creatinine Increased
10 (.23%)
Coronary Artery Thrombosis
10 (.23%)
Decreased Appetite
10 (.23%)
Hepatotoxicity
10 (.23%)
Peripheral Ischaemia
10 (.23%)
Premature Baby
10 (.23%)
Pulmonary Haemorrhage
10 (.23%)
Rash
10 (.23%)
Treatment Related Secondary Maligna...
10 (.23%)
Bacterial Sepsis
9 (.21%)
Disease Progression
9 (.21%)
Encephalopathy
9 (.21%)
Fatigue
9 (.21%)

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

What are the most common Bleomycin Sulfate 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 Sulfate, 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 Sulfate 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 Sulfate According to Those Reporting Adverse Events

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

Hodgkins Disease
591
Testis Cancer
136
Germ Cell Cancer
86
Diffuse Large B-cell Lymphoma
64
Non-hodgkins Lymphoma
46
T-cell Lymphoma
38
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Lymphoma
34
Testicular Germ Cell Cancer
33
Product Used For Unknown Indication
24
Seminoma
21
Peripheral T-cell Lymphoma Unspecif...
18
Chemotherapy
16
Ovarian Cancer
16
Drug Use For Unknown Indication
14
Testicular Seminoma (pure)
14
Ovarian Germ Cell Cancer
13
B-cell Lymphoma
13
Choriocarcinoma
10
Penis Carcinoma
10
Pseudolymphoma
9
Testicular Neoplasm
8
Hodgkins Disease Stage Ii
8
Ewings Sarcoma
7
Yolk Sac Tumour Site Unspecified
7
Non-hodgkins Lymphoma Stage Iv
7
Testicular Cancer Metastatic
6
Malignant Lymphoid Neoplasm
6
Teratoma
6
Kaposis Sarcoma Aids Related
6
Ovarian Neoplasm
6
Hodgkins Disease Nodular Sclerosis ...
5
Cervix Carcinoma
5
Craniopharyngioma
5
Pituitary Tumour
5
Bone Sarcoma
5
Hodgkins Disease Stage Iv
4
Kaposis Sarcoma
4
Ovarian Germ Cell Endodermal Sinus ...
4
Burkitts Lymphoma
4
Testicular Germ Cell Tumour Mixed S...
4
Epstein-barr Virus Associated Lymph...
4
Neoplasm
4
Mantle Cell Lymphoma
4
Testicular Embryonal Carcinoma
4
Hodgkins Disease Stage Iii
3
Post Transplant Lymphoproliferative...
3
Brain Neoplasm
3
Non-hodgkins Lymphoma Stage Ii
3
Mycosis Fungoides
3
Nongerminomatous Germ Cell Tumour O...
3
Teratoma Of Testis
3

Bleomycin Sulfate Case Reports

What Bleomycin Sulfate 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 Sulfate. 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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