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EPOPROSTENOL SODIUM

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Epoprostenol Sodium Adverse Events Reported to the FDA Over Time

How are Epoprostenol Sodium adverse event reports trending over time?

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

Most Common Epoprostenol Sodium Adverse Events Reported to the FDA

What are the most common Epoprostenol Sodium adverse events reported to the FDA?

Dyspnoea
411 (3.53%)
Death
363 (3.12%)
Nausea
230 (1.98%)
Diarrhoea
206 (1.77%)
Vomiting
187 (1.61%)
Pneumonia
186 (1.6%)
Right Ventricular Failure
155 (1.33%)
Pulmonary Arterial Hypertension
153 (1.31%)
Headache
149 (1.28%)
Pyrexia
142 (1.22%)
Cardiac Failure
135 (1.16%)
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Catheter Related Complication
129 (1.11%)
Pulmonary Hypertension
123 (1.06%)
Device Related Infection
118 (1.01%)
Malaise
114 (.98%)
Condition Aggravated
113 (.97%)
Hypotension
113 (.97%)
Pain In Jaw
105 (.9%)
Dizziness
104 (.89%)
Fluid Overload
103 (.89%)
Oedema Peripheral
103 (.89%)
Flushing
102 (.88%)
Fatigue
98 (.84%)
Ascites
89 (.76%)
Thrombocytopenia
86 (.74%)
Hypoxia
83 (.71%)
Pain In Extremity
82 (.7%)
Rash
79 (.68%)
Abdominal Pain
78 (.67%)
Disease Progression
78 (.67%)
Asthenia
73 (.63%)
Gastrointestinal Haemorrhage
73 (.63%)
Fluid Retention
71 (.61%)
Anaemia
70 (.6%)
Chest Pain
70 (.6%)
Decreased Appetite
70 (.6%)
Syncope
68 (.58%)
Platelet Count Decreased
66 (.57%)
Respiratory Failure
66 (.57%)
Weight Increased
66 (.57%)
Renal Failure
64 (.55%)
Fall
63 (.54%)
Haemoptysis
61 (.52%)
Pulmonary Oedema
61 (.52%)
Abdominal Distension
58 (.5%)
Back Pain
58 (.5%)
Medical Device Complication
57 (.49%)
Sepsis
55 (.47%)
Dehydration
53 (.46%)
Oedema
53 (.46%)
Pleural Effusion
52 (.45%)
Weight Decreased
52 (.45%)
Pain
51 (.44%)
Epistaxis
50 (.43%)
Renal Failure Acute
50 (.43%)
Oxygen Saturation Decreased
49 (.42%)
Haemoglobin Decreased
48 (.41%)
Pulmonary Alveolar Haemorrhage
47 (.4%)
Cough
46 (.4%)
Palpitations
45 (.39%)
Transfusion
45 (.39%)
Blood Pressure Decreased
44 (.38%)
Dyspnoea Exertional
44 (.38%)
Infection
44 (.38%)
Erythema
42 (.36%)
Hyperthyroidism
42 (.36%)
Pulmonary Haemorrhage
42 (.36%)
Tachycardia
42 (.36%)
Cardiac Failure Congestive
41 (.35%)
Catheter Site Erythema
41 (.35%)
Staphylococcal Infection
41 (.35%)
Haemorrhage
38 (.33%)
Pericardial Effusion
38 (.33%)
Cardiac Arrest
37 (.32%)
Cellulitis
35 (.3%)
Swelling
35 (.3%)
Urinary Tract Infection
34 (.29%)
Chills
32 (.28%)
General Physical Health Deteriorati...
32 (.28%)
Heart Rate Increased
32 (.28%)
Catheter Site Infection
31 (.27%)
Device Leakage
31 (.27%)
Lung Transplant
31 (.27%)
Catheter Related Infection
30 (.26%)
Loss Of Consciousness
29 (.25%)
Thrombosis
29 (.25%)
Paracentesis
28 (.24%)
Pallor
26 (.22%)
Vision Blurred
26 (.22%)
Anxiety
25 (.21%)
Cardio-respiratory Arrest
25 (.21%)
Drug Administration Error
25 (.21%)
Arthralgia
24 (.21%)
Bacteraemia
24 (.21%)
Upper Respiratory Tract Infection
23 (.2%)
Blood Creatinine Increased
22 (.19%)
Cardiogenic Shock
22 (.19%)
International Normalised Ratio Incr...
22 (.19%)
Nephrolithiasis
22 (.19%)
Pruritus
22 (.19%)
Pulmonary Congestion
22 (.19%)

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

What are the most common Epoprostenol Sodium adverse events reported to the FDA?

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

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

Pulmonary Arterial Hypertension
1449
Pulmonary Hypertension
560
Product Used For Unknown Indication
156
Drug Use For Unknown Indication
117
Cor Pulmonale Chronic
31
Ill-defined Disorder
14
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Connective Tissue Disorder
14
Collagen Disorder
9
Essential Hypertension
9
Portopulmonary Hypertension
8
Eisenmengers Syndrome
7
Heart Disease Congenital
7
Pulmonary Thrombosis
5
Systemic Sclerosis
5
Vasodilation Procedure
5
Portal Hypertension
4
Congenital Diaphragmatic Hernia
4
Lung Disorder
4
Mixed Connective Tissue Disease
4
Pulmonary Embolism
3
Congenital Pulmonary Hypertension
3
Multi-organ Failure
3
Hypertension
3
Ventricular Septal Defect
2
Cardiac Disorder
2
Maternal Exposure During Pregnancy
2
Pulmonary Arterial Pressure Increas...
2
Vasodilatation
2
Prophylaxis
2
Diagnostic Procedure
2
Sarcoidosis
2
Persistent Foetal Circulation
2
Crest Syndrome
2
Hypoxia
1
Necrosis
1
Scleroderma
1
Haemangioma
1
Anticoagulant Therapy
1
Pulmonary Vascular Disorder
1
Drug Exposure During Pregnancy
1
Cardiomyopathy
1
Systemic Lupus Erythematosus
1
Digital Ulcer
1
Blood Viscosity Increased
1
Arterial Disorder
1
Oxygen Saturation Decreased
1
Cardiac Fibrillation
1
Haemodialysis
1
Hepatic Cirrhosis
1
Postoperative Care
1
Pain In Extremity
1

Drug Labels

LabelLabelerEffective
FlolanGlaxoSmithKline LLC05-APR-11
DiluentGlaxoSmithKline LLC05-APR-11
Sterile DiluentTeva Parenteral Medicines, Inc.19-DEC-12
Epoprostenol SodiumTeva Parenteral Medicines, Inc.19-DEC-12

Epoprostenol Sodium Case Reports

What Epoprostenol Sodium 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 Epoprostenol Sodium. 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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