SOVALDI: 825 Adverse Event Reports & Safety Profile

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825

Total FAERS Reports

37 (4.5%)

Deaths Reported

110

Hospitalizations

825

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 2005 · Latest Report: 20140625

What Are the Most Common SOVALDI Side Effects?

#1 Most Reported

Fatigue

100 reports (12.1%)

#2 Most Reported

Off label use

84 reports (10.2%)

#3 Most Reported

Headache

77 reports (9.3%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Fatigue	100	12.1%	1	9
Off label use	84	10.2%	4	12
Headache	77	9.3%	0	2
Nausea	59	7.2%	2	7
Dyspnoea	47	5.7%	0	10
Overdose	45	5.5%	0	1
Rash	43	5.2%	0	2
Anaemia	40	4.9%	3	9
Insomnia	40	4.9%	0	3
Vomiting	29	3.5%	4	6
Haemoglobin decreased	28	3.4%	0	8
Accidental overdose	27	3.3%	0	0
Dizziness	26	3.2%	0	2
Drug ineffective	23	2.8%	1	2
Influenza like illness	21	2.6%	0	0
Pyrexia	19	2.3%	0	5
Death	18	2.2%	18	3
Depression	18	2.2%	0	2
Malaise	18	2.2%	0	4
Pain	17	2.1%	0	2

Average age: 56.1 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2005	1	0	0
2012	1	0	1
2013	5	0	0
2014	394	18	59

Indication	Reports
Hepatitis c	391
Product used for unknown indication	274
Chronic hepatitis c	105

Official prescribing information from the FDA-approved drug label.