VELETRI: 333 Adverse Event Reports & Safety Profile

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333

Total FAERS Reports

90 (27.0%)

Deaths Reported

252

Hospitalizations

333

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 201103 · Latest Report: 20140616

What Are the Most Common VELETRI Side Effects?

#1 Most Reported

Dyspnoea

59 reports (17.7%)

#2 Most Reported

Death

48 reports (14.4%)

#3 Most Reported

Nausea

36 reports (10.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Dyspnoea	59	17.7%	25	52
Death	48	14.4%	48	24
Nausea	36	10.8%	12	26
Pulmonary arterial hypertension	34	10.2%	17	30
Pneumonia	33	9.9%	7	33
Headache	30	9.0%	8	20
Vomiting	27	8.1%	9	21
Diarrhoea	26	7.8%	10	22
Pain in jaw	23	6.9%	6	15
Right ventricular failure	23	6.9%	20	18
Fluid retention	21	6.3%	12	19
Condition aggravated	18	5.4%	8	14
Dizziness	18	5.4%	7	16
Flushing	18	5.4%	4	12
Malaise	17	5.1%	9	13
Dehydration	15	4.5%	4	15
Fatigue	15	4.5%	4	12
Fluid overload	15	4.5%	8	15
Oedema	14	4.2%	10	13
Pyrexia	14	4.2%	3	12

Average age: 53.4 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2011	3	0	3
2012	9	5	8
2013	55	26	47
2014	111	37	87

Indication	Reports
Pulmonary arterial hypertension	235
Cor pulmonale chronic	43
Product used for unknown indication	17
Pulmonary hypertension	14
Portopulmonary hypertension	8

Official prescribing information from the FDA-approved drug label.