Dofetilide Side Effects

Brand Names: Tikosyn

Please note - some side effects for Dofetilide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dofetilide - for the Consumer

Dofetilide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dofetilide:

Dizziness; headache; nausea; respiratory tract infection.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; difficulty breathing; fast, slow, or irregular heartbeat; fainting; heart attack; pale stool; paralysis; pounding in the chest; stopping of the heart; sudden death; yellowing of the skin or eyes.

Side Effects by Body System

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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