OpenClaim

Bosentan Side Effects

The most commonly reported side effects of bosentan include death, dyspnoea, and death, based on 53,804 FDA adverse event reports from 2004 to 2025.

Bosentan side effects

Percentages show how often each reaction appears relative to total reports for bosentan.

1
Death11.4%6,133
2
Dyspnoea9.2%4,924
3
Death9.1%4,906
4
Pneumonia3.9%2,123
5
Headache3.7%1,975
6
Fatigue3.6%1,934
7
Pulmonary Arterial Hypertension3.4%1,844
8
Diarrhoea3.3%1,790
9
Nausea3.2%1,737
10
Malaise2.9%1,559
11
Dizziness2.8%1,503
12
Dyspnoea2.6%1,390
13
Condition Aggravated2.6%1,381
14
Cough2.5%1,350
15
Fall2.4%1,315

These are voluntary reports and do not establish that bosentan caused these reactions.

Report severity

84.5%Serious45,479 reports
48.7%Hospitalizations26,225 reports
33.2%Fatal17,846 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bosentan drug interactions

Other drugs that appear in adverse event reports alongside bosentan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Treprostinil11.2%6,025
2
Iloprost3.8%2,029
3
Epoprostenol-sodium3.4%1,831
4
Sildenafil-citrate3.4%1,806
5
Selexipag2.1%1,146
6
Tadalafil1.5%833
7
Macitentan1.1%585
8
Riociguat0.9%506
9
Ambrisentan0.9%504
10
Warfarin0.7%378
11
Furosemide0.5%292
12
Mycophenolate0.3%158
13
Aspirin0.3%137
14
Spironolactone0.2%130
15
Rituximab0.2%128

Taken alongside

1
Sildenafil-citrate21.9%11,771
2
Warfarin17.7%9,526
3
Tadalafil9.9%5,314
4
Furosemide9.1%4,903
5
Treprostinil6.6%3,554
6
Spironolactone4.6%2,469
7
Oxygen4.3%2,323
8
Aspirin4.1%2,224
9
Calcium2.9%1,576
10
Levothyroxine-sodium2.7%1,476
11
Digoxin2.7%1,452
12
Amlodipine2.5%1,350
13
Albuterol2.4%1,315
14
Omeprazole2.4%1,312
15
Prednisone2.4%1,280

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bosentan side effects

54.0% of bosentan adverse event reports involve female patients and 19.5% involve male patients. The largest age group is adult at 45%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.0%
Male19.5%
Unknown26.5%

Age group

< 24.2%
2–114.8%
12–172.1%
18–6445.0%
65+43.8%

What is bosentan used for

Conditions and purposes for which patients were taking bosentan when the adverse event was reported.

Accidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAinhumAlveolar Capillary DysplasiaAnaemiaAngina PectorisAngiopathyAntiphospholipid SyndromeAntiretroviral TherapyAortic Valve DiseaseArterial DisorderArterial Occlusive DiseaseArteriosclerosis Coronary ArteryArteriospasm Coronary

Showing 15 of 315 indications

Bosentan brand names and reporting trend

Bosentan is sold under the brand name Tracleer.

Brand names

Tracleer14,870

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bosentan with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.