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Ventavis Adverse Events Reported to the FDA Over Time

How are Ventavis adverse event reports trending over time?

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

Most Common Ventavis Adverse Events Reported to the FDA

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

Death
595 (6.23%)
Dyspnoea
368 (3.85%)
Headache
253 (2.65%)
Dizziness
241 (2.52%)
Cough
222 (2.32%)
Nausea
197 (2.06%)
Fatigue
151 (1.58%)
Condition Aggravated
145 (1.52%)
Oedema Peripheral
126 (1.32%)
Pulmonary Hypertension
120 (1.26%)
Pneumonia
119 (1.25%)
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Hypotension
116 (1.21%)
Pulmonary Arterial Hypertension
114 (1.19%)
Chest Pain
111 (1.16%)
Syncope
109 (1.14%)
Asthenia
87 (.91%)
Flushing
85 (.89%)
Right Ventricular Failure
83 (.87%)
Fluid Retention
75 (.79%)
Cardiac Failure
73 (.76%)
Vomiting
71 (.74%)
Disease Progression
70 (.73%)
Fall
68 (.71%)
Respiratory Failure
68 (.71%)
Oedema
67 (.7%)
Chest Discomfort
65 (.68%)
Diarrhoea
65 (.68%)
Pain In Extremity
59 (.62%)
Loss Of Consciousness
56 (.59%)
Anaemia
54 (.57%)
Chronic Obstructive Pulmonary Disea...
53 (.55%)
Bronchitis
51 (.53%)
Cardiac Failure Congestive
51 (.53%)
Epistaxis
51 (.53%)
Malaise
51 (.53%)
Throat Irritation
51 (.53%)
Urinary Tract Infection
49 (.51%)
Cardiac Arrest
47 (.49%)
Hypoxia
47 (.49%)
Palpitations
45 (.47%)
Myocardial Infarction
43 (.45%)
Oxygen Saturation Decreased
43 (.45%)
Renal Failure
43 (.45%)
Blood Pressure Decreased
41 (.43%)
Abdominal Pain Upper
40 (.42%)
Cardiac Disorder
40 (.42%)
Pulmonary Oedema
40 (.42%)
Abdominal Pain
39 (.41%)
Haemoptysis
39 (.41%)
Transfusion
39 (.41%)
Dehydration
38 (.4%)
General Physical Health Deteriorati...
37 (.39%)
Nasal Congestion
36 (.38%)
Renal Failure Acute
36 (.38%)
Atrial Fibrillation
35 (.37%)
Pain In Jaw
35 (.37%)
Pyrexia
34 (.36%)
Dysphonia
30 (.31%)
Sepsis
30 (.31%)
Cyanosis
29 (.3%)
Heart Rate Increased
29 (.3%)
Confusional State
28 (.29%)
Drug Dose Omission
28 (.29%)
No Therapeutic Response
28 (.29%)
Weight Increased
28 (.29%)
Back Pain
27 (.28%)
Fluid Overload
27 (.28%)
Liver Function Test Abnormal
27 (.28%)
Lung Disorder
27 (.28%)
Pleural Effusion
27 (.28%)
Decreased Appetite
26 (.27%)
Drug Ineffective
26 (.27%)
Infection
26 (.27%)
Premature Baby
26 (.27%)
Haemoglobin Decreased
25 (.26%)
Pulmonary Embolism
25 (.26%)
Dialysis
24 (.25%)
Tachycardia
24 (.25%)
Blood Pressure Increased
23 (.24%)
Cellulitis
23 (.24%)
Cerebrovascular Accident
23 (.24%)
Hypoaesthesia
23 (.24%)
Scleroderma
23 (.24%)
Swelling Face
23 (.24%)
Ascites
22 (.23%)
Somnolence
22 (.23%)
Sudden Death
22 (.23%)
Caesarean Section
21 (.22%)
Gastrointestinal Haemorrhage
21 (.22%)
Glossodynia
21 (.22%)
Oral Discomfort
21 (.22%)
Pregnancy
21 (.22%)
Pruritus
21 (.22%)
Rash
21 (.22%)
Tremor
21 (.22%)
Blood Glucose Decreased
20 (.21%)
Bradycardia
20 (.21%)
Cardio-respiratory Arrest
20 (.21%)
Feeling Abnormal
20 (.21%)
International Normalised Ratio Incr...
20 (.21%)
Pulmonary Arterial Pressure Increas...
20 (.21%)

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

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

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

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

Pulmonary Arterial Hypertension
1991
Pulmonary Hypertension
715
Product Used For Unknown Indication
42
Drug Use For Unknown Indication
19
Drug Exposure During Pregnancy
13
Systemic Sclerosis
8
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Peripheral Ischaemia
4
Pulmonary Embolism
3
Raynauds Phenomenon
3
Maternal Exposure During Pregnancy
2
Vascular Test
2
Thromboangiitis Obliterans
2
Hypertension
2
Pulmonary Hypertensive Crisis
2
Cor Pulmonale Chronic
1
Accidental Exposure
1
Ischaemic Limb Pain
1
Multiple Sclerosis
1
Cardiac Disorder
1
Eisenmengers Syndrome
1
Idiopathic Pulmonary Fibrosis
1
Pulmonary Veno-occlusive Disease
1
Crest Syndrome
1
Chronic Obstructive Pulmonary Disea...
1
Scleroderma
1
Foetal Exposure During Pregnancy
1
Respiratory Failure
1

Drug Labels

LabelLabelerEffective
VentavisActelion Pharmaceuticals US, Inc.31-AUG-12

Ventavis Case Reports

What Ventavis 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 Ventavis. 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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