Drug Safety Information for TIKOSYN (Dofetilide)

Adverse Drug Reactions for TIKOSYN* (Dofetilide)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TIKOSYN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Atrial fibrillation	524
2	Drug ineffective	366
3	Dizziness*	262
4	Electrocardiogram qt prolonged	232
5	Dyspnoea*	226
6	Fatigue*	202
7	Headache	183
8	Drug interaction	171
9	Heart rate increased	159
10	Arrhythmia	147
11	Death	145
12	Nausea*	125
13	Malaise	124
14	Diarrhoea	123
15	Asthenia	120
16	Cardiac disorder	119
17	Chest pain*	116
18	Condition aggravated	105
19	Feeling abnormal	98
20	Pain	97

* This side effect also appears in "Top 10 Side Effects of TIKOSYN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TIKOSYN
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Atrial fibrillation*	6192
2	Arrhythmia	558
3	Atrial flutter	317
4	Ill-defined disorder	292
5	Product used for unknown indication	268
6	Heart rate irregular	266
7	Cardiac disorder	183
8	Ventricular tachycardia	129
9	Heart rate increased	125
10	Cardiac failure congestive	54

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for TIKOSYN

Total Reports Filed with FDA: 13468

Number of FDA Adverse Event Reports by Patient Age for TIKOSYN

Total Reports Filed with FDA: 13468*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dofetilide (Tikosyn)

Charts are based on 13468 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.