DIANEAL PD2: 858 Adverse Event Reports & Safety Profile

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858

Total FAERS Reports

91 (10.6%)

Deaths Reported

529

Hospitalizations

858

As Primary/Secondary Suspect

Disabilities

First Report: 2003 · Latest Report: 20140613

What Are the Most Common DIANEAL PD2 Side Effects?

#1 Most Reported

Fluid overload

68 reports (7.9%)

#2 Most Reported

Hypotension

52 reports (6.1%)

#3 Most Reported

Peritonitis bacterial

50 reports (5.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Fluid overload	68	7.9%	4	23
Hypotension	52	6.1%	5	33
Peritoneal dialysis complication	50	5.8%	1	39
Peritonitis	50	5.8%	5	45
Peritonitis bacterial	50	5.8%	3	41
Pneumonia	49	5.7%	9	44
Dehydration	48	5.6%	1	18
Hypertension	41	4.8%	1	17
Vomiting	25	2.9%	1	20
Fall	24	2.8%	4	19
Myocardial infarction	24	2.8%	17	16
Constipation	21	2.5%	1	16
Cerebrovascular accident	20	2.3%	4	19
Death	20	2.3%	20	11
Fluid retention	20	2.3%	0	7
Abdominal pain	18	2.1%	0	15
Cardiac disorder	18	2.1%	8	14
Dyspnoea	17	2.0%	1	13
Cardiac arrest	16	1.9%	13	11
Abdominal distension	15	1.8%	0	3

Average age: 50.8 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2003	1	0	1
2008	1	0	1
2009	1	0	0
2010	2	0	1
2011	2	0	2
2012	32	3	28
2013	128	13	95
2014	412	37	247

Indication	Reports
Peritoneal dialysis	760
Renal failure chronic	126

Official prescribing information from the FDA-approved drug label.