HEPSERA: 55 Adverse Event Reports & Safety Profile

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Total FAERS Reports

2 (3.6%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Disabilities

First Report: 200505 · Latest Report: 201404

What Are the Most Common HEPSERA Side Effects?

#1 Most Reported

Osteomalacia

15 reports (27.3%)

#2 Most Reported

Hypophosphataemia

14 reports (25.5%)

#3 Most Reported

Fanconi syndrome acquired

11 reports (20.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Osteomalacia	15	27.3%	1	10
Hypophosphataemia	14	25.5%	1	8
Fanconi syndrome acquired	11	20.0%	1	4
Drug resistance	10	18.2%	1	2
Hepatitis b dna increased	10	18.2%	0	1
Arthralgia	9	16.4%	1	5
Blood phosphorus decreased	9	16.4%	0	4
Back pain	8	14.6%	0	5
Drug ineffective	8	14.6%	0	0
Bone pain	7	12.7%	0	4
Renal impairment	7	12.7%	0	2
Pain	6	10.9%	0	4
Pain in extremity	6	10.9%	0	2
Condition aggravated	5	9.1%	0	3
Muscular weakness	5	9.1%	0	4
Nephrolithiasis	5	9.1%	0	1
Osteoporosis	5	9.1%	0	4
Proteinuria	5	9.1%	0	0
Renal tubular disorder	5	9.1%	0	2

Average age: 49.9 years. Most reports from: CN. View detailed demographics →

Year	Reports	Deaths	Hosp.
2005	1	0	0
2006	1	0	1
2007	1	1	1
2008	1	0	1
2009	3	0	0
2010	2	0	2
2011	4	1	1
2012	6	0	3
2013	17	0	9
2014	3	0	0

Indication	Reports
Hepatitis b	26
Chronic hepatitis b	19

Official prescribing information from the FDA-approved drug label.