TIKOSYN: 285 Adverse Event Reports & Safety Profile

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285

Total FAERS Reports

13 (4.6%)

Deaths Reported

Hospitalizations

285

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 200901 · Latest Report: 20140616

What Are the Most Common TIKOSYN Side Effects?

#1 Most Reported

Drug ineffective

29 reports (10.2%)

#2 Most Reported

Atrial fibrillation

23 reports (8.1%)

#3 Most Reported

Cardiac disorder

18 reports (6.3%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	29	10.2%	0	3
Atrial fibrillation	23	8.1%	0	10
Cardiac disorder	18	6.3%	0	6
Malaise	17	6.0%	0	1
Drug interaction	15	5.3%	0	1
Fatigue	11	3.9%	0	0
Headache	11	3.9%	0	0
Death	10	3.5%	10	0
Diarrhoea	10	3.5%	0	0
Dyspnoea	9	3.2%	0	5
Heart rate increased	9	3.2%	0	1
Dizziness	8	2.8%	0	0
Electrocardiogram qt prolonged	8	2.8%	0	2
Muscle spasms	8	2.8%	0	0
Arrhythmia	7	2.5%	0	1
Palpitations	7	2.5%	0	1
Constipation	6	2.1%	0	0
Nausea	6	2.1%	0	1
Pain	6	2.1%	0	2
Pain in extremity	6	2.1%	0	1

Average age: 69.3 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2009	1	0	0
2010	1	0	0
2012	1	0	1
2013	36	5	5
2014	84	1	16

Indication	Reports
Atrial fibrillation	124
Atrial flutter	26
Arrhythmia	13
Product used for unknown indication	5

Official prescribing information from the FDA-approved drug label.