VIAGRA: 1,138 Adverse Event Reports & Safety Profile

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1,138

Total FAERS Reports

11 (1.0%)

Deaths Reported

Hospitalizations

1,138

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 1998 · Latest Report: 20140624

What Are the Most Common VIAGRA Side Effects?

#1 Most Reported

Drug ineffective

413 reports (36.3%)

#2 Most Reported

Erection increased

124 reports (10.9%)

#3 Most Reported

Headache

74 reports (6.5%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	413	36.3%	0	0
Erection increased	124	10.9%	0	0
Headache	74	6.5%	0	0
Drug effect incomplete	58	5.1%	0	0
Flushing	31	2.7%	0	0
Suspected counterfeit product	29	2.6%	0	0
Dizziness	20	1.8%	0	1
Nasal congestion	20	1.8%	0	0
Nasopharyngitis	19	1.7%	0	0
Penis disorder	17	1.5%	0	0
Product quality issue	17	1.5%	0	0
Drug effect decreased	15	1.3%	0	0
Malaise	15	1.3%	0	0
Premature ejaculation	15	1.3%	0	0
Cerebrovascular accident	14	1.2%	0	0
Pre-existing condition improved	13	1.1%	0	0
Diabetes mellitus	12	1.1%	0	0
Drug effect delayed	12	1.1%	0	0
Ejaculation failure	12	1.1%	0	0
Off label use	12	1.1%	2	0

Average age: 58.9 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2000	1	0	0
2001	1	0	0
2002	1	0	0
2003	3	0	0
2004	1	0	0
2007	2	0	1
2008	4	0	0
2009	3	0	0
2010	6	0	2
2011	7	0	3
2012	11	0	1
2013	83	1	7
2014	193	2	10

Indication	Reports
Erectile dysfunction	347
Sexual dysfunction	17
Product used for unknown indication	8
Pulmonary hypertension	5

Official prescribing information from the FDA-approved drug label.