Tikosyn Side Effects

Generic name: dofetilide

Note: This document contains side effect information about dofetilide. Some of the dosage forms listed on this page may not apply to the brand name Tikosyn.

Some side effects of Tikosyn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dofetilide: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking dofetilide (the active ingredient contained in Tikosyn) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• headache with chest pain and severe dizziness;

• fast or pounding heartbeats, feeling like you might pass out;

• low magnesium (confusion, uneven heart rate, jerking muscle movements, muscle weakness or limp feeling); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects of dofetilide may include:

• mild headache;

• mild dizziness;

• sleep problems (insomnia);

• back pain;

• nausea, diarrhea, stomach pain;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dofetilide: oral capsule

Cardiovascular

Torsade de pointes is the only arrhythmia reported by the manufacturer that showed a dose-response relationship.

Cardiovascular effects have included ventricular arrhythmias, AV block, bundle branch block, heart block, chest pain, angioedema, bradycardia, cerebral ischemia, cerebrovascular accident, edema, heart arrest and myocardial infarct.

General

General side effects including headache (11%), dizziness (8%), flu syndrome ( 4%), insomnia (4%), accidental injury (3%), back pain (3%) and rash (3%) and sudden death have been reported.

Gastrointestinal

Gastrointestinal effects have included nausea (5%), diarrhea (3%) and abdominal pain (3%).

Respiratory

Respiratory effects have included respiratory tract infection (7%), dyspnea (6%) and cough.

Nervous system

Nervous system effects have included paresthesias, facial paralysis, paralysis, flaccid paralysis, migraine and syncope.

Hepatic

Hepatic side effects including liver damage has been reported with a frequency of less than 2%.

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