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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.

BOSENTAN\BOSENTAN: 3,493 Adverse Event Reports & Safety Profile

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3,493
Total FAERS Reports
1,114 (31.9%)
Deaths Reported
2,331
Hospitalizations
3,493
As Primary/Secondary Suspect
126
Life-Threatening
65
Disabilities

Active Ingredient: BOSENTAN\BOSENTAN MONOHYDRATE ·

First Report: 19331127 · Latest Report: 20150616

What Are the Most Common BOSENTAN\BOSENTAN Side Effects?

#1 Most Reported
Death
543 reports (15.5%)
#2 Most Reported
Dyspnoea
443 reports (12.7%)
#3 Most Reported
Pulmonary arterial hypertension
245 reports (7.0%)

All BOSENTAN\BOSENTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 543 15.6% 542 118
Dyspnoea 443 12.7% 104 384
Pulmonary arterial hypertension 245 7.0% 149 143
Pneumonia 220 6.3% 62 202
Fall 182 5.2% 22 160
Condition aggravated 161 4.6% 84 95
Fluid retention 125 3.6% 30 117
Syncope 115 3.3% 17 97
Nausea 113 3.2% 20 95
Fatigue 111 3.2% 15 87
Dizziness 106 3.0% 11 90
Disease progression 99 2.8% 84 49
Malaise 98 2.8% 22 82
Cardiac failure congestive 97 2.8% 37 77
Cough 97 2.8% 10 74
Oedema peripheral 95 2.7% 24 83
Atrial fibrillation 94 2.7% 9 85
Cardiac failure 94 2.7% 64 55
Asthenia 92 2.6% 20 78
Anaemia 89 2.6% 20 78

Who Reports BOSENTAN\BOSENTAN Side Effects? Age & Gender Data

Gender: 73.8% female, 26.2% male. Average age: 58.9 years. Most reports from: US. View detailed demographics →

Is BOSENTAN\BOSENTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2004 3 1 2
2005 2 0 1
2006 1 0 1
2007 4 0 4
2008 6 0 6
2009 12 3 9
2010 16 1 13
2011 36 7 34
2012 66 14 59
2013 142 40 121
2014 1,349 428 974
2015 551 252 322

View full timeline →

What Is BOSENTAN\BOSENTAN Used For?

IndicationReports
Pulmonary arterial hypertension 2,673
Cor pulmonale chronic 238
Pulmonary hypertension 238
Product used for unknown indication 187
Scleroderma associated digital ulcer 38
Systemic sclerosis 16
Skin ulcer 15
Portopulmonary hypertension 10
Raynaud's phenomenon 8
Heart disease congenital 7

BOSENTAN\BOSENTAN vs Alternatives: Which Is Safer?

BOSENTAN\BOSENTAN vs BOSUTINIB BOSENTAN\BOSENTAN vs BOTOX BOSENTAN\BOSENTAN vs BOTOX COSMETIC BOSENTAN\BOSENTAN vs BOTULINUM TOXIN NOS BOSENTAN\BOSENTAN vs BOTULINUM TOXIN TYPE A BOSENTAN\BOSENTAN vs BREMELANOTIDE BOSENTAN\BOSENTAN vs BRENTUXIMAB BOSENTAN\BOSENTAN vs BRENTUXIMAB VEDOTIN BOSENTAN\BOSENTAN vs BREO ELLIPTA BOSENTAN\BOSENTAN vs BREXANOLONE

Official FDA Label for BOSENTAN\BOSENTAN

Official prescribing information from the FDA-approved drug label.