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Tracleer Adverse Events Reported to the FDA Over Time

How are Tracleer adverse event reports trending over time?

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

Most Common Tracleer Adverse Events Reported to the FDA

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

Death
5349 (7.97%)
Dyspnoea
2281 (3.4%)
Aspartate Aminotransferase Increase...
1419 (2.11%)
Alanine Aminotransferase Increased
1401 (2.09%)
Pneumonia
1050 (1.56%)
Liver Function Test Abnormal
957 (1.43%)
Pulmonary Arterial Hypertension
875 (1.3%)
Condition Aggravated
824 (1.23%)
Oedema Peripheral
811 (1.21%)
Blood Alkaline Phosphatase Increase...
766 (1.14%)
Fatigue
605 (.9%)
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Blood Bilirubin Increased
600 (.89%)
Anaemia
578 (.86%)
Dizziness
570 (.85%)
Right Ventricular Failure
570 (.85%)
Fall
566 (.84%)
Nausea
565 (.84%)
Pulmonary Hypertension
562 (.84%)
Respiratory Failure
538 (.8%)
Cardiac Failure Congestive
534 (.8%)
Fluid Retention
516 (.77%)
Pyrexia
512 (.76%)
Cardiac Failure
476 (.71%)
Disease Progression
474 (.71%)
Syncope
473 (.7%)
Chest Pain
446 (.66%)
Vomiting
441 (.66%)
Pulmonary Oedema
404 (.6%)
Oedema
396 (.59%)
Hypotension
395 (.59%)
Renal Failure
389 (.58%)
Cough
376 (.56%)
Headache
375 (.56%)
Malaise
374 (.56%)
Diarrhoea
371 (.55%)
Asthenia
368 (.55%)
Chronic Obstructive Pulmonary Disea...
362 (.54%)
Gamma-glutamyltransferase Increased
350 (.52%)
Sepsis
335 (.5%)
Pregnancy
304 (.45%)
Transfusion
295 (.44%)
Abdominal Pain
275 (.41%)
Atrial Fibrillation
274 (.41%)
Gastrointestinal Haemorrhage
271 (.4%)
Myocardial Infarction
266 (.4%)
Haemoglobin Decreased
265 (.39%)
Dehydration
257 (.38%)
Cardiac Arrest
251 (.37%)
Pleural Effusion
251 (.37%)
Off Label Use
244 (.36%)
Cerebrovascular Accident
238 (.35%)
Weight Increased
235 (.35%)
Oxygen Saturation Decreased
232 (.35%)
Drug Exposure During Pregnancy
225 (.34%)
Fluid Overload
225 (.34%)
Hypoxia
225 (.34%)
Infection
214 (.32%)
Cardiac Disorder
209 (.31%)
Haemorrhage
205 (.31%)
Urinary Tract Infection
203 (.3%)
Renal Failure Acute
201 (.3%)
Loss Of Consciousness
198 (.3%)
Pain
197 (.29%)
Device Related Infection
189 (.28%)
Ascites
184 (.27%)
Hepatic Function Abnormal
180 (.27%)
Pericardial Effusion
178 (.27%)
General Physical Health Deteriorati...
169 (.25%)
Platelet Count Decreased
169 (.25%)
International Normalised Ratio Incr...
166 (.25%)
Back Pain
165 (.25%)
Weight Decreased
164 (.24%)
Bronchitis
161 (.24%)
Drug Interaction
159 (.24%)
Abdominal Pain Upper
157 (.23%)
Cellulitis
157 (.23%)
Lung Disorder
156 (.23%)
Decreased Appetite
152 (.23%)
Epistaxis
151 (.23%)
Swelling
151 (.23%)
Pain In Extremity
150 (.22%)
Multi-organ Failure
148 (.22%)
Hepatic Cirrhosis
147 (.22%)
Liver Disorder
144 (.21%)
Pulmonary Embolism
144 (.21%)
Cardiac Pacemaker Insertion
143 (.21%)
Hepatic Enzyme Increased
141 (.21%)
Pulmonary Fibrosis
141 (.21%)
Arthralgia
138 (.21%)
Renal Disorder
135 (.2%)
Pruritus
132 (.2%)
Lung Transplant
130 (.19%)
Dialysis
129 (.19%)
Abdominal Distension
128 (.19%)
Nasopharyngitis
128 (.19%)
Palpitations
126 (.19%)
Concomitant Disease Aggravated
125 (.19%)
Heart Rate Increased
125 (.19%)
Hepatic Failure
125 (.19%)
Haemoptysis
124 (.18%)
Chest Discomfort
121 (.18%)

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

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

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

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

Pulmonary Arterial Hypertension
14957
Pulmonary Hypertension
3561
Skin Ulcer
327
Product Used For Unknown Indication
226
Drug Use For Unknown Indication
199
Digital Ulcer
39
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Scleroderma
38
Drug Exposure During Pregnancy
31
Systemic Sclerosis
29
Raynauds Phenomenon
21
Portopulmonary Hypertension
18
Accidental Exposure
13
Scleroderma Renal Crisis
13
Maternal Exposure During Pregnancy
12
Hypertension
11
Pulmonary Fibrosis
10
Extremity Necrosis
10
Pulmonary Embolism
9
Interstitial Lung Disease
8
Eisenmengers Syndrome
7
Idiopathic Pulmonary Fibrosis
6
Prinzmetal Angina
6
Sarcoidosis
5
Cor Pulmonale Chronic
5
Pulmonary Veno-occlusive Disease
4
Dyspnoea
4
Lung Disorder
4
Foetal Exposure During Pregnancy
3
Portal Hypertension
3
Emphysema
3
Mixed Connective Tissue Disease
3
Cardiac Disorder
3
Connective Tissue Disorder
3
Cardiac Operation
2
Cor Pulmonale
2
Thromboangiitis Obliterans
2
Chronic Obstructive Pulmonary Disea...
2
Vasculitis
2
Prophylaxis
2
Heart Transplant
2
Heart Disease Congenital
2
Systemic Sclerosis Pulmonary
2
Ventricular Dysfunction
2
Autoimmune Disorder
2
Cardiac Valve Disease
2
Hepatic Function Abnormal
2
Pulmonary Arterial Pressure Decreas...
2
Peripheral Ischaemia
1
Left Ventricular Dysfunction
1
Vasospasm
1
Chronic Obstructive Airways Disease
1

Drug Labels

LabelLabelerEffective
TracleerActelion Pharmaceuticals US, Inc.31-OCT-12

Tracleer Case Reports

What Tracleer 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 Tracleer. 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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