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Bortezomib Adverse Events Reported to the FDA Over Time

How are Bortezomib adverse event reports trending over time?

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

Most Common Bortezomib Adverse Events Reported to the FDA

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

Thrombocytopenia
183 (2.6%)
Neuropathy Peripheral
157 (2.23%)
Diarrhoea
153 (2.17%)
Pneumonia
146 (2.07%)
Pyrexia
133 (1.89%)
Neutropenia
131 (1.86%)
Nausea
112 (1.59%)
Anaemia
109 (1.55%)
Febrile Neutropenia
108 (1.53%)
Fatigue
103 (1.46%)
Infection
88 (1.25%)
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Dyspnoea
86 (1.22%)
Multiple Myeloma
81 (1.15%)
Dehydration
76 (1.08%)
Asthenia
73 (1.04%)
Disease Progression
73 (1.04%)
Sepsis
73 (1.04%)
Vomiting
72 (1.02%)
Hypotension
71 (1.01%)
Pleural Effusion
68 (.97%)
Constipation
67 (.95%)
Platelet Count Decreased
62 (.88%)
Herpes Zoster
58 (.82%)
Dizziness
57 (.81%)
Haemoglobin Decreased
55 (.78%)
Gastrointestinal Inflammation
51 (.72%)
Death
49 (.7%)
Confusional State
48 (.68%)
Hypoxia
47 (.67%)
Renal Failure
45 (.64%)
Leukopenia
43 (.61%)
Syncope
43 (.61%)
Decreased Appetite
40 (.57%)
Atrial Fibrillation
39 (.55%)
Renal Failure Acute
39 (.55%)
Lymphopenia
36 (.51%)
Pancytopenia
36 (.51%)
Hypokalaemia
35 (.5%)
Hyponatraemia
35 (.5%)
Pulmonary Embolism
35 (.5%)
Septic Shock
35 (.5%)
Deep Vein Thrombosis
34 (.48%)
Oedema Peripheral
34 (.48%)
Rash
32 (.45%)
Abdominal Pain
31 (.44%)
Neurotoxicity
30 (.43%)
Peripheral Sensory Neuropathy
30 (.43%)
Blood Creatinine Increased
29 (.41%)
Aspartate Aminotransferase Increase...
28 (.4%)
Interstitial Lung Disease
28 (.4%)
Alanine Aminotransferase Increased
27 (.38%)
Hypertension
27 (.38%)
Staphylococcal Infection
27 (.38%)
White Blood Cell Count Decreased
27 (.38%)
Myocardial Infarction
26 (.37%)
Pain
26 (.37%)
Chest Pain
25 (.35%)
Chills
25 (.35%)
Fall
25 (.35%)
Blood Lactate Dehydrogenase Increas...
24 (.34%)
Cough
23 (.33%)
Malignant Neoplasm Progression
23 (.33%)
Tumour Lysis Syndrome
23 (.33%)
Hypercalcaemia
21 (.3%)
Lung Disorder
21 (.3%)
Mucosal Inflammation
21 (.3%)
Muscular Weakness
21 (.3%)
Off Label Use
21 (.3%)
Respiratory Failure
21 (.3%)
Atelectasis
20 (.28%)
Bacteraemia
20 (.28%)
Back Pain
19 (.27%)
Cardiac Failure Congestive
19 (.27%)
Mental Status Changes
19 (.27%)
Orthostatic Hypotension
19 (.27%)
Tachycardia
19 (.27%)
Upper Respiratory Tract Infection
19 (.27%)
Blood Culture Positive
18 (.26%)
Cardiac Failure
18 (.26%)
Somnolence
18 (.26%)
Hyperglycaemia
17 (.24%)
Lung Infection
17 (.24%)
Diverticulitis
16 (.23%)
Failure To Thrive
16 (.23%)
Thrombosis
16 (.23%)
Cerebral Ischaemia
15 (.21%)
Electrolyte Imbalance
15 (.21%)
Gastrointestinal Haemorrhage
15 (.21%)
Haematotoxicity
15 (.21%)
Haemorrhage
15 (.21%)
Headache
15 (.21%)
Insomnia
15 (.21%)
Neuralgia
15 (.21%)
Cellulitis
14 (.2%)
Drug Ineffective
14 (.2%)
Gastrointestinal Toxicity
14 (.2%)
Haematocrit Decreased
14 (.2%)
Hypophosphataemia
14 (.2%)
International Normalised Ratio Incr...
14 (.2%)
Multi-organ Failure
14 (.2%)
Oedema
14 (.2%)

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

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

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

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

Multiple Myeloma
1070
Mantle Cell Lymphoma
65
Acute Lymphocytic Leukaemia
41
Non-hodgkins Lymphoma
37
Drug Use For Unknown Indication
36
B-cell Lymphoma
30
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Non-small Cell Lung Cancer
23
Acute Myeloid Leukaemia
19
Neoplasm Malignant
19
Waldenstroms Macroglobulinaemia
18
Amyloidosis
17
Leukaemia Plasmacytic
16
Plasmacytoma
16
Renal Cell Carcinoma
15
Product Used For Unknown Indication
15
Lung Neoplasm Malignant
13
Myeloma Recurrence
13
Prophylaxis Against Transplant Reje...
11
Diffuse Large B-cell Lymphoma
10
Lymphoma
8
Adenoid Cystic Carcinoma
6
Breast Cancer Metastatic
6
Neuroblastoma
6
Chemotherapy
5
Stem Cell Transplant
4
T-cell Lymphoma
4
Post Transplant Lymphoproliferative...
4
Mantle Cell Lymphoma Stage Iv
4
Gastric Cancer
4
Glioblastoma
4
Follicle Centre Lymphoma, Follicula...
4
Bone Lesion
3
Pancytopenia
3
T-cell Type Acute Leukaemia
3
Metastatic Malignant Melanoma
3
Breast Cancer
3
Transitional Cell Carcinoma
3
Small Cell Lung Cancer Metastatic
3
Acute Lymphocytic Leukaemia Recurre...
3
Haematological Malignancy
3
Colon Cancer
2
Colon Cancer Metastatic
2
Blood Immunoglobulin M Increased
2
Renal Impairment
2
Neoplasm
2
Renal Cell Carcinoma Stage Unspecif...
2
Ovarian Epithelial Cancer
2
Squamous Cell Carcinoma
2
Glioblastoma Multiforme
2
Renal Cancer
2
T-cell Lymphoma Refractory
2

Drug Labels

LabelLabelerEffective
VelcadeMillennium Pharmaceuticals, Inc.31-OCT-12

Bortezomib Case Reports

What Bortezomib 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 Bortezomib. 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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