OPSUMIT: 339 Adverse Event Reports & Safety Profile

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339

Total FAERS Reports

64 (18.9%)

Deaths Reported

117

Hospitalizations

339

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20120910 · Latest Report: 20140609

What Are the Most Common OPSUMIT Side Effects?

#1 Most Reported

Dyspnoea

52 reports (15.3%)

#2 Most Reported

Headache

33 reports (9.7%)

#3 Most Reported

Death

27 reports (8.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Dyspnoea	52	15.3%	5	24
Headache	33	9.7%	1	2
Death	27	8.0%	27	6
Nausea	21	6.2%	2	4
Cough	19	5.6%	1	5
Fluid retention	19	5.6%	2	9
Malaise	19	5.6%	0	6
Nasal congestion	19	5.6%	0	2
Pneumonia	19	5.6%	9	15
Oedema peripheral	17	5.0%	0	7
Pulmonary arterial hypertension	16	4.7%	10	10
Disease progression	14	4.1%	13	8
Fatigue	13	3.8%	0	5
Fluid overload	13	3.8%	4	12
Oedema	13	3.8%	1	6
Diarrhoea	12	3.5%	0	4
Pulmonary oedema	12	3.5%	4	12
Weight increased	11	3.2%	0	2
Anaemia	10	3.0%	1	7
Condition aggravated	10	3.0%	1	5

Average age: 65.1 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2012	1	0	1
2013	26	5	9
2014	107	35	55

Indication	Reports
Pulmonary arterial hypertension	176
Product used for unknown indication	73
Pulmonary hypertension	41
Cor pulmonale chronic	21
Connective tissue disorder	7
Cardiac disorder	6
Portopulmonary hypertension	6

Official prescribing information from the FDA-approved drug label.