BOSENTAN for Systemic scleroderma: Side Effects & Safety Data

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There are 120 adverse event reports in the FDA FAERS database where BOSENTAN was used for Systemic scleroderma.

Most Reported Side Effects for BOSENTAN

Side Effect	Reports	%	Deaths	Hosp.
Dyspnoea	2,492	12.7%	501	1,640
Death	2,388	12.2%	2,384	689
Pneumonia	1,064	5.4%	264	946
Fatigue	1,025	5.2%	116	449
Headache	962	4.9%	94	467
Hospitalisation	915	4.7%	105	913
Malaise	894	4.6%	130	445
Diarrhoea	840	4.3%	132	484
Product dose omission issue	798	4.1%	18	174
Pulmonary arterial hypertension	778	4.0%	358	506
Nausea	765	3.9%	98	428
Condition aggravated	739	3.8%	239	464
Dizziness	721	3.7%	95	376
Cough	705	3.6%	100	400
Off label use	659	3.4%	100	272