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EVOLTRA

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Evoltra Adverse Events Reported to the FDA Over Time

How are Evoltra adverse event reports trending over time?

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

Most Common Evoltra Adverse Events Reported to the FDA

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

Sepsis
119 (2.86%)
Multi-organ Failure
110 (2.64%)
Pyrexia
108 (2.59%)
Neutropenia
96 (2.3%)
Thrombocytopenia
87 (2.09%)
Febrile Neutropenia
85 (2.04%)
Pancytopenia
80 (1.92%)
Respiratory Failure
75 (1.8%)
Septic Shock
64 (1.54%)
Acute Myeloid Leukaemia
62 (1.49%)
Neutropenic Sepsis
61 (1.46%)
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Renal Failure Acute
59 (1.42%)
Bone Marrow Failure
52 (1.25%)
Alanine Aminotransferase Increased
47 (1.13%)
Aspartate Aminotransferase Increase...
46 (1.1%)
Pneumonia
46 (1.1%)
Renal Failure
46 (1.1%)
Diarrhoea
44 (1.06%)
Death
42 (1.01%)
Infection
42 (1.01%)
Cardiac Arrest
35 (.84%)
Blood Bilirubin Increased
33 (.79%)
Atrial Fibrillation
32 (.77%)
Neutropenic Colitis
32 (.77%)
Palmar-plantar Erythrodysaesthesia ...
31 (.74%)
Acute Myeloid Leukaemia Recurrent
30 (.72%)
Cardiac Failure
30 (.72%)
Fungal Infection
28 (.67%)
Bronchopulmonary Aspergillosis
27 (.65%)
Hypotension
26 (.62%)
Rash
26 (.62%)
Caecitis
25 (.6%)
Renal Impairment
25 (.6%)
Cerebral Haemorrhage
24 (.58%)
Hypokalaemia
24 (.58%)
Tumour Lysis Syndrome
24 (.58%)
Dyspnoea
23 (.55%)
Haemoglobin Decreased
22 (.53%)
Capillary Leak Syndrome
21 (.5%)
Metabolic Acidosis
21 (.5%)
Pleural Effusion
21 (.5%)
Blood Creatinine Increased
20 (.48%)
Hyperbilirubinaemia
20 (.48%)
Mucosal Inflammation
20 (.48%)
Nausea
19 (.46%)
Oedema
19 (.46%)
Vomiting
19 (.46%)
Bacteraemia
18 (.43%)
Disease Progression
18 (.43%)
Platelet Count Decreased
18 (.43%)
Acute Respiratory Distress Syndrome
17 (.41%)
Fall
17 (.41%)
Adenovirus Infection
16 (.38%)
Pulmonary Embolism
16 (.38%)
Confusional State
15 (.36%)
Nephropathy Toxic
15 (.36%)
Staphylococcal Infection
15 (.36%)
Aplasia
14 (.34%)
Clostridium Difficile Colitis
14 (.34%)
Decreased Appetite
14 (.34%)
Disseminated Intravascular Coagulat...
14 (.34%)
Lung Infection
14 (.34%)
Malignant Neoplasm Progression
14 (.34%)
Chest Pain
13 (.31%)
Chills
13 (.31%)
Coma
13 (.31%)
Cytolytic Hepatitis
13 (.31%)
Encephalopathy
13 (.31%)
Haemoptysis
13 (.31%)
Ileus
13 (.31%)
Pericarditis
13 (.31%)
Gamma-glutamyltransferase Increased
12 (.29%)
General Physical Health Deteriorati...
12 (.29%)
Neurotoxicity
12 (.29%)
Oedema Peripheral
12 (.29%)
Anaemia
11 (.26%)
Blood Alkaline Phosphatase Increase...
11 (.26%)
Central Nervous System Lesion
11 (.26%)
Fasciitis
11 (.26%)
Gastrointestinal Necrosis
11 (.26%)
Leukaemia Recurrent
11 (.26%)
Pain In Extremity
11 (.26%)
Staphylococcal Sepsis
11 (.26%)
White Blood Cell Count Decreased
11 (.26%)
Abdominal Pain
10 (.24%)
Acute Leukaemia
10 (.24%)
Anuria
10 (.24%)
Blister
10 (.24%)
Cystitis Haemorrhagic
10 (.24%)
Delirium
10 (.24%)
Device Related Infection
10 (.24%)
Epilepsy
10 (.24%)
Haematocrit Decreased
10 (.24%)
Haemorrhage Intracranial
10 (.24%)
Hepatic Function Abnormal
10 (.24%)
Pneumonia Fungal
10 (.24%)
Pulmonary Haemorrhage
10 (.24%)
Pulmonary Oedema
10 (.24%)
Syncope
10 (.24%)
Acute Lymphocytic Leukaemia
9 (.22%)
Aspergillosis
9 (.22%)

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

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

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

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

Acute Myeloid Leukaemia
550
Acute Leukaemia
183
Acute Lymphocytic Leukaemia
132
Haematological Malignancy
26
Product Used For Unknown Indication
22
Myelodysplastic Syndrome
20
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Bone Marrow Conditioning Regimen
16
Acute Myeloid Leukaemia Recurrent
16
Non-hodgkins Lymphoma
7
Acute Lymphocytic Leukaemia Recurre...
7
Myeloid Leukaemia
5
Drug Use For Unknown Indication
4
Acute Myelomonocytic Leukaemia
2
Leukaemia Recurrent
2
Stem Cell Transplant
2
T-cell Lymphoma
1
Refractory Anaemia With An Excess O...
1
Acute Biphenotypic Leukaemia
1
Myeloproliferative Disorder
1
Leukaemia
1
Myelodysplastic Syndrome Transforma...
1

Evoltra Case Reports

What Evoltra 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 Evoltra. 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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