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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TRACLEER: 1,864 Adverse Event Reports & Safety Profile

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1,864
Total FAERS Reports
738 (39.6%)
Deaths Reported
1,160
Hospitalizations
1,864
As Primary/Secondary Suspect
85
Life-Threatening
48
Disabilities

First Report: 2003 · Latest Report: 20140617

What Are the Most Common TRACLEER Side Effects?

#1 Most Reported
Death
382 reports (20.5%)
#2 Most Reported
Dyspnoea
229 reports (12.3%)
#3 Most Reported
Pulmonary arterial hypertension
127 reports (6.8%)

All TRACLEER Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 382 20.5% 382 85
Dyspnoea 229 12.3% 64 201
Pulmonary arterial hypertension 127 6.8% 85 70
Pneumonia 121 6.5% 41 109
Condition aggravated 86 4.6% 46 55
Fall 79 4.2% 16 65
Fluid retention 65 3.5% 20 60
Dizziness 63 3.4% 10 57
Cardiac failure congestive 60 3.2% 23 48
Aspartate aminotransferase increased 59 3.2% 8 35
Fatigue 59 3.2% 10 50
Alanine aminotransferase increased 57 3.1% 8 33
Malaise 57 3.1% 16 49
Disease progression 54 2.9% 47 21
Syncope 54 2.9% 11 48
Anaemia 52 2.8% 12 45
Asthenia 50 2.7% 10 45
Cough 50 2.7% 7 43
Liver function test abnormal 50 2.7% 7 28
Right ventricular failure 50 2.7% 39 35

Who Reports TRACLEER Side Effects? Age & Gender Data

Average age: 60.1 years. Most reports from: US. View detailed demographics →

Is TRACLEER Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2005 3 0 2
2006 4 2 2
2007 6 2 4
2008 5 0 4
2009 8 0 7
2010 19 4 15
2011 49 9 41
2012 81 14 68
2013 374 149 256
2014 673 328 403

View full timeline →

What Is TRACLEER Used For?

IndicationReports
Pulmonary arterial hypertension 1,472
Pulmonary hypertension 116
Cor pulmonale chronic 101
Product used for unknown indication 86
Skin ulcer 14
Scleroderma associated digital ulcer 8
Systemic lupus erythematosus 6
Connective tissue disorder 5
Scleroderma 5
Systemic sclerosis 5

TRACLEER vs Alternatives: Which Is Safer?

TRACLEER vs TRADJENTA TRACLEER vs TRALOKINUMAB-LDRM TRACLEER vs TRAMADOL TRACLEER vs TRAMADOL\TRAMADOL TRACLEER vs TRAMETINIB TRACLEER vs TRAMETINIB DIMETHYL SULFOXIDE TRACLEER vs TRANDOLAPRIL TRACLEER vs TRANDOLAPRIL\VERAPAMIL TRACLEER vs TRANEXAMIC ACID TRACLEER vs TRANYLCYPROMINE

Official FDA Label for TRACLEER

Official prescribing information from the FDA-approved drug label.