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FLOLAN

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Flolan Adverse Events Reported to the FDA Over Time

How are Flolan adverse event reports trending over time?

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

Most Common Flolan Adverse Events Reported to the FDA

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

Dyspnoea
396 (3.49%)
Death
348 (3.07%)
Nausea
218 (1.92%)
Diarrhoea
197 (1.74%)
Pneumonia
186 (1.64%)
Vomiting
181 (1.59%)
Right Ventricular Failure
150 (1.32%)
Headache
144 (1.27%)
Pulmonary Arterial Hypertension
143 (1.26%)
Pyrexia
140 (1.23%)
Cardiac Failure
132 (1.16%)
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Catheter Related Complication
129 (1.14%)
Pulmonary Hypertension
120 (1.06%)
Device Related Infection
114 (1%)
Hypotension
108 (.95%)
Malaise
108 (.95%)
Condition Aggravated
105 (.93%)
Dizziness
102 (.9%)
Fluid Overload
101 (.89%)
Oedema Peripheral
101 (.89%)
Pain In Jaw
98 (.86%)
Fatigue
96 (.85%)
Flushing
96 (.85%)
Ascites
88 (.78%)
Thrombocytopenia
86 (.76%)
Hypoxia
80 (.7%)
Pain In Extremity
79 (.7%)
Abdominal Pain
78 (.69%)
Disease Progression
77 (.68%)
Rash
76 (.67%)
Gastrointestinal Haemorrhage
73 (.64%)
Fluid Retention
71 (.63%)
Anaemia
70 (.62%)
Chest Pain
70 (.62%)
Asthenia
69 (.61%)
Decreased Appetite
69 (.61%)
Syncope
66 (.58%)
Platelet Count Decreased
65 (.57%)
Weight Increased
65 (.57%)
Renal Failure
63 (.56%)
Respiratory Failure
62 (.55%)
Fall
61 (.54%)
Haemoptysis
61 (.54%)
Pulmonary Oedema
61 (.54%)
Abdominal Distension
58 (.51%)
Back Pain
58 (.51%)
Medical Device Complication
56 (.49%)
Sepsis
53 (.47%)
Pleural Effusion
52 (.46%)
Weight Decreased
52 (.46%)
Oedema
51 (.45%)
Pain
50 (.44%)
Renal Failure Acute
50 (.44%)
Dehydration
49 (.43%)
Epistaxis
49 (.43%)
Haemoglobin Decreased
47 (.41%)
Oxygen Saturation Decreased
47 (.41%)
Pulmonary Alveolar Haemorrhage
47 (.41%)
Transfusion
45 (.4%)
Blood Pressure Decreased
44 (.39%)
Infection
44 (.39%)
Dyspnoea Exertional
43 (.38%)
Cough
42 (.37%)
Hyperthyroidism
42 (.37%)
Palpitations
42 (.37%)
Pulmonary Haemorrhage
42 (.37%)
Cardiac Failure Congestive
41 (.36%)
Catheter Site Erythema
41 (.36%)
Erythema
41 (.36%)
Staphylococcal Infection
41 (.36%)
Haemorrhage
38 (.33%)
Tachycardia
38 (.33%)
Pericardial Effusion
35 (.31%)
Swelling
35 (.31%)
Cellulitis
34 (.3%)
Urinary Tract Infection
34 (.3%)
Cardiac Arrest
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%)
Chills
28 (.25%)
Loss Of Consciousness
28 (.25%)
Thrombosis
28 (.25%)
Paracentesis
27 (.24%)
Pallor
26 (.23%)
Vision Blurred
26 (.23%)
Anxiety
25 (.22%)
Drug Administration Error
25 (.22%)
Arthralgia
24 (.21%)
Bacteraemia
24 (.21%)
Upper Respiratory Tract Infection
23 (.2%)
Nephrolithiasis
22 (.19%)
Pruritus
22 (.19%)
Pulmonary Congestion
22 (.19%)
Stent Placement
22 (.19%)
Alanine Aminotransferase Increased
21 (.19%)
Blood Creatinine Increased
21 (.19%)
Cardio-respiratory Arrest
21 (.19%)

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

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

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

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

Pulmonary Arterial Hypertension
1392
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
DiluentGlaxoSmithKline LLC05-APR-11
FlolanGlaxoSmithKline LLC05-APR-11

Flolan Case Reports

What Flolan 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 Flolan. 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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