SIMPONI: 704 Adverse Event Reports & Safety Profile

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704

Total FAERS Reports

26 (3.7%)

Deaths Reported

288

Hospitalizations

704

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 2006 · Latest Report: 20140629

What Are the Most Common SIMPONI Side Effects?

#1 Most Reported

Pneumonia

50 reports (7.1%)

#2 Most Reported

Drug ineffective

36 reports (5.1%)

#3 Most Reported

Device malfunction

29 reports (4.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Pneumonia	50	7.1%	3	28
Drug ineffective	36	5.1%	0	5
Device malfunction	29	4.1%	0	8
Drug dose omission	26	3.7%	0	9
Pain	24	3.4%	1	10
Diarrhoea	21	3.0%	0	5
Rheumatoid arthritis	20	2.8%	2	3
Vomiting	20	2.8%	0	5
Fall	18	2.6%	0	11
Malaise	18	2.6%	0	6
Off label use	18	2.6%	0	9
Abdominal pain	17	2.4%	0	3
Arthralgia	16	2.3%	1	4
Dyspnoea	16	2.3%	0	8
Nausea	16	2.3%	0	4
Cellulitis	15	2.1%	0	8
Headache	15	2.1%	0	6
Sepsis	15	2.1%	2	15
Urinary tract infection	15	2.1%	0	10
Infection	14	2.0%	0	9

Average age: 59.2 years. Most reports from: JP. View detailed demographics →

Year	Reports	Deaths	Hosp.
2006	1	0	1
2009	2	0	1
2010	6	0	0
2011	16	1	6
2012	80	5	42
2013	221	4	102
2014	184	6	77

Indication	Reports
Rheumatoid arthritis	365
Product used for unknown indication	126
Ankylosing spondylitis	77
Psoriatic arthropathy	75
Colitis ulcerative	26
Crohn's disease	12
Spondylitis	7
Psoriasis	5

Official prescribing information from the FDA-approved drug label.