VYVANSE: 507 Adverse Event Reports & Safety Profile

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507

Total FAERS Reports

7 (1.4%)

Deaths Reported

Hospitalizations

507

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20040222 · Latest Report: 201408

What Are the Most Common VYVANSE Side Effects?

#1 Most Reported

Drug ineffective

65 reports (12.8%)

#2 Most Reported

Product quality issue

58 reports (11.4%)

#3 Most Reported

Drug effect decreased

46 reports (9.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	65	12.8%	0	1
Product quality issue	58	11.4%	0	0
Drug effect decreased	46	9.1%	0	0
Decreased appetite	33	6.5%	0	1
No adverse event	33	6.5%	0	0
Depression	28	5.5%	0	4
Off label use	28	5.5%	0	2
Anxiety	23	4.5%	0	2
Insomnia	23	4.5%	0	1
Aggression	22	4.3%	0	4
Disturbance in attention	20	3.9%	0	1
Feeling abnormal	20	3.9%	1	1
Hallucination	18	3.6%	0	3
Drug prescribing error	17	3.4%	0	1
Inappropriate schedule of drug administration	17	3.4%	0	0
Agitation	16	3.2%	0	6
Prescribed overdose	16	3.2%	0	1
Tic	16	3.2%	0	0
Headache	15	3.0%	0	1
Drug dose omission	13	2.6%	0	1

Average age: 22.7 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2004	1	0	0
2008	1	0	0
2009	1	0	0
2010	3	0	0
2011	10	0	2
2012	17	1	2
2013	80	3	6
2014	145	2	5

Indication	Reports
Product used for unknown indication	248
Attention deficit/hyperactivity disorder	234

Official prescribing information from the FDA-approved drug label.