BETASERON: 591 Adverse Event Reports & Safety Profile

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591

Total FAERS Reports

21 (3.6%)

Deaths Reported

Hospitalizations

591

As Primary/Secondary Suspect

Disabilities

First Report: 1993 · Latest Report: 20140619

What Are the Most Common BETASERON Side Effects?

#1 Most Reported

Influenza like illness

65 reports (11.0%)

#2 Most Reported

Injection site pain

43 reports (7.3%)

#3 Most Reported

Multiple sclerosis relapse

41 reports (6.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Influenza like illness	65	11.0%	0	2
Injection site pain	43	7.3%	0	3
Drug ineffective	41	6.9%	0	0
Multiple sclerosis relapse	41	6.9%	1	8
Multiple sclerosis	38	6.4%	1	5
Injection site erythema	35	5.9%	0	1
Depression	33	5.6%	0	2
Fatigue	29	4.9%	0	2
Drug dose omission	22	3.7%	0	5
Injection site bruising	22	3.7%	0	2
Injection site mass	22	3.7%	0	1
Injection site reaction	22	3.7%	0	0
Hypoaesthesia	21	3.6%	0	4
Gait disturbance	20	3.4%	0	0
Chills	19	3.2%	0	1
Headache	19	3.2%	0	1
Pain	19	3.2%	0	2
Pain in extremity	19	3.2%	0	4
Death	17	2.9%	17	3
Nausea	17	2.9%	0	1

Average age: 50.3 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2000	3	0	0
2001	3	0	0
2002	2	0	0
2003	3	0	3
2004	8	0	2
2006	2	0	2
2007	3	0	0
2008	2	0	1
2009	3	0	1
2010	9	0	1
2011	15	0	1
2012	19	0	5
2013	78	6	13
2014	155	8	28

Indication	Reports
Multiple sclerosis	367
Relapsing-remitting multiple sclerosis	71
Product used for unknown indication	19
Secondary progressive multiple sclerosis	7

Official prescribing information from the FDA-approved drug label.