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TYVASO

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Tyvaso Adverse Events Reported to the FDA Over Time

How are Tyvaso adverse event reports trending over time?

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

Most Common Tyvaso Adverse Events Reported to the FDA

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

Death
329 (8.33%)
Dyspnoea
224 (5.67%)
Pneumonia
155 (3.92%)
Pulmonary Arterial Hypertension
94 (2.38%)
Syncope
85 (2.15%)
Fluid Retention
73 (1.85%)
Cardiac Failure Congestive
68 (1.72%)
Cough
66 (1.67%)
Hypotension
63 (1.59%)
Chest Pain
62 (1.57%)
Pulmonary Hypertension
59 (1.49%)
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Dizziness
58 (1.47%)
Headache
47 (1.19%)
Nausea
47 (1.19%)
Asthenia
43 (1.09%)
Fluid Overload
43 (1.09%)
Vomiting
39 (.99%)
Fatigue
38 (.96%)
Oxygen Saturation Decreased
38 (.96%)
Treatment Noncompliance
38 (.96%)
Oedema
36 (.91%)
Anaemia
35 (.89%)
Fall
35 (.89%)
Oedema Peripheral
35 (.89%)
Bronchitis
34 (.86%)
Condition Aggravated
33 (.84%)
Epistaxis
33 (.84%)
Respiratory Failure
31 (.78%)
Gastrointestinal Haemorrhage
30 (.76%)
Pulmonary Oedema
30 (.76%)
Diarrhoea
29 (.73%)
Chest Discomfort
28 (.71%)
Haemoglobin Decreased
28 (.71%)
Cardiac Arrest
26 (.66%)
Throat Irritation
26 (.66%)
Myocardial Infarction
25 (.63%)
Renal Failure
25 (.63%)
Urinary Tract Infection
24 (.61%)
Cardiac Failure
23 (.58%)
Dehydration
23 (.58%)
Right Ventricular Failure
23 (.58%)
Swelling
22 (.56%)
Hypoxia
21 (.53%)
Atrial Fibrillation
20 (.51%)
Cerebrovascular Accident
20 (.51%)
Drug Dose Omission
20 (.51%)
Drug Ineffective
19 (.48%)
Haemoptysis
19 (.48%)
Loss Of Consciousness
18 (.46%)
Cardiac Disorder
17 (.43%)
Disease Progression
17 (.43%)
Malaise
17 (.43%)
Lung Disorder
16 (.41%)
Chronic Obstructive Pulmonary Disea...
15 (.38%)
Interstitial Lung Disease
15 (.38%)
Decreased Appetite
14 (.35%)
Haemorrhage
14 (.35%)
Medication Error
14 (.35%)
Asthma
13 (.33%)
Pyrexia
13 (.33%)
Weight Decreased
13 (.33%)
Heart Rate Increased
12 (.3%)
Abdominal Pain
11 (.28%)
Confusional State
11 (.28%)
Pain
11 (.28%)
Respiratory Distress
11 (.28%)
Sepsis
11 (.28%)
Sickle Cell Anaemia With Crisis
11 (.28%)
Blood Potassium Decreased
10 (.25%)
Gastrointestinal Disorder
10 (.25%)
Surgery
10 (.25%)
Atrial Flutter
9 (.23%)
Blood Disorder
9 (.23%)
Convulsion
9 (.23%)
Feeling Abnormal
9 (.23%)
International Normalised Ratio Incr...
9 (.23%)
Pain In Extremity
9 (.23%)
Platelet Count Decreased
9 (.23%)
Abdominal Distension
8 (.2%)
Acute Respiratory Failure
8 (.2%)
Blood Pressure Decreased
8 (.2%)
Cardio-respiratory Arrest
8 (.2%)
Influenza
8 (.2%)
Lethargy
8 (.2%)
Liver Function Test Abnormal
8 (.2%)
Pain In Jaw
8 (.2%)
Renal Failure Acute
8 (.2%)
Systemic Lupus Erythematosus
8 (.2%)
Unresponsive To Stimuli
8 (.2%)
Abdominal Pain Upper
7 (.18%)
Dialysis
7 (.18%)
Dyspepsia
7 (.18%)
Haematoma
7 (.18%)
Multi-organ Failure
7 (.18%)
Palpitations
7 (.18%)
Post Procedural Complication
7 (.18%)
Pulmonary Embolism
7 (.18%)
Respiratory Tract Infection
7 (.18%)
Tachycardia
7 (.18%)
Chills
6 (.15%)
Disease Complication
6 (.15%)

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

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

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

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

Pulmonary Arterial Hypertension
968
Cor Pulmonale Chronic
393
Pulmonary Hypertension
227
Hypertension
21
Systemic Sclerosis
17
Product Used For Unknown Indication
7
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Cor Pulmonale
7
Portal Hypertension
6
Chronic Obstructive Pulmonary Disea...
4
Essential Hypertension
4
Scleroderma
4
Sarcoidosis
3
Pulmonary Embolism
3
Hepatic Cirrhosis
2
Fibrosis
2
Connective Tissue Disorder
2
Sickle Cell Anaemia
2
Ph Body Fluid
2
Rheumatoid Arthritis
2
Thrombosis
2
Systemic Lupus Erythematosus
2
Portopulmonary Hypertension
1
Heart Disease Congenital
1
Embolism Arterial
1
Lung Disorder
1
Idiopathic Pulmonary Fibrosis
1
Asthma
1
Hereditary Haemorrhagic Telangiecta...
1
Atrial Septal Defect
1

Drug Labels

LabelLabelerEffective
TyvasoUnited Therapeutics Corp.15-DEC-11

Tyvaso Case Reports

What Tyvaso 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 Tyvaso. 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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