Tikosyn

Last updated on RxList: 2/25/2021
Tikosyn Side Effects Center

What Is Tikosyn?

Tikosyn (dofetilide) is an antiarrhythmic drug used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart). Tikosyn is used in people with atrial fibrillation or atrial flutter.

What Are Side Effects of Tikosyn?

Common side effects of Tikosyn include:

Seek immediate medical attention if you have rare but serious side effects of Tikosyn including:

  • chest pain,
  • fainting,
  • faster or more irregular heartbeat, or
  • severe dizziness.

Dosage for Tikosyn

The usual recommended dose of Tikosyn is 500 mcg twice daily. When starting, restarting, or increasing the dose, you will need to stay in the hospital for at least 3 days for monitoring.

What Drugs, Substances, or Supplements Interact with Tikosyn?

Tikosyn may interact with diuretics (water pills), HIV/AIDS medicine, drugs that can affect heart rhythm, narcotics, antibiotics, antidepressants, medicines to treat psychiatric disorders, or heart rhythm medicine. Tell your doctor all medications you are taking.

Tikosyn During Pregnancy and Breastfeeding

During pregnancy, Tikosyn should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tikosyn (dofetilide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tikosyn Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • loss of appetite, vomiting or severe diarrhea; or
  • low magnesium or potassium--confusion, uneven heart rate, increased thirst or urination, sweating, jerking muscle movements, leg discomfort, muscle weakness or limp feeling.

Common side effects may include:

  • mild headache;
  • mild dizziness; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tikosyn (Dofetilide)

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Heart Disease: Symptoms, Signs, and Causes See Slideshow
Tikosyn Professional Information

SIDE EFFECTS

The TIKOSYN clinical program involved approximately 8,600 patients in 130 clinical studies of normal volunteers and patients with supraventricular and ventricular arrhythmias. TIKOSYN was administered to 5,194 patients, including two large, placebo-controlled mortality trials (DIAMOND CHF and DIAMOND MI) in which 1,511 patients received TIKOSYN for up to three years.

In the following section, adverse reaction data for cardiac arrhythmias and non-cardiac adverse reactions are presented separately for patients included in the supraventricular arrhythmia development program and for patients included in the DIAMOND CHF and MI mortality trials (see Clinical Studies, Safety in Patients with Structural Heart Disease, DIAMOND Studies, for a description of these trials).

In studies of patients with supraventricular arrhythmias, a total of 1,346 and 677 patients were exposed to TIKOSYN and placebo for 551 and 207 patient years, respectively. A total of 8.7% of patients in the dofetilide groups were discontinued from clinical trials due to adverse events compared to 8.0% in the placebo groups. The most frequent reason for discontinuation (>1%) was ventricular tachycardia (2.0% on dofetilide vs. 1.3% on placebo). The most frequent adverse events were headache, chest pain, and dizziness.

Serious Arrhythmias And Conduction Disturbances

Torsade de Pointes is the only arrhythmia that showed a dose-response relationship to TIKOSYN treatment. It did not occur in placebo treated patients. The incidence of Torsade de Pointes in patients with supraventricular arrhythmias was 0.8% (11/1346) (see WARNINGS). The incidence of Torsade de Pointes in patients who were dosed according to the recommended dosing regimen (see DOSAGE AND ADMINISTRATION) was 0.8% (4/525). Table 6 shows the frequency by randomized dose of serious arrhythmias and conduction disturbances reported as adverse events in patients with supraventricular arrhythmias.

Table 6: Incidence of Serious Arrhythmias and Conduction Disturbances in Patients with Supraventricular Arrhythmias

Arrhythmia event:TIKOSYN DosePlacebo
N=677
<250 mcg BID
N=217
250 mcg BID
N=388
>250-500 mcg BID
N=703
>500 mcg BID
N=38
Ventricular arrhythmias* †3.7%2.6%3.4%15.8%2.7%
Ventricular fibrillation00.3%0.4%2.6%0.1%
Ventricular tachycardia†3.7%2.6%3.3%13.2%2.5%
Torsade de Pointes00.3%0.9%10.5%0
Various forms of block
AV block0.9%1.5%0.4%00.3%
Bundle branch block00.5%0.1%00.1%
Heart block00.5%0.1%00.1%
*Patients with more than one arrhythmia are counted only once in this category.
†Ventricular arrhythmias and ventricular tachycardia include all cases of Torsade de Pointes.

In the DIAMOND trials, a total of 1,511 patients were exposed to TIKOSYN for 1757 patient years. The incidence of Torsade de Pointes was 3.3% in CHF patients and 0.9% in patients with a recent MI.

Table 7 shows the incidence of serious arrhythmias and conduction disturbances reported as adverse events in the DIAMOND subpopulation that had AF at entry to these trials.

Table 7: Incidence of Serious Arrhythmias and Conduction Disturbances in Patients with AF at Entry to the DIAMOND Studies

TIKOSYN
N=249
Placebo
N=257
Ventricular arrhythmias*,†14.5%13.6%
Ventricular fibrillation4.8%3.1%
Ventricular tachycardia†12.4%11.3%
Torsade de Pointes1.6%0
Various forms of block
AV block0.8%2.7%
(Left) bundle branch block00.4%
Heart block1.2%0.8%
*Patients with more than one arrhythmia are counted only once in this category.
†Ventricular arrhythmias and ventricular tachycardia include all cases of Torsade de Pointes.

Other Adverse Reactions

Table 8 presents other adverse events reported with a frequency of >2% on TIKOSYN and reported numerically more frequently on TIKOSYN than on placebo in the studies of patients with supraventricular arrhythmias.

Table 8: Frequency of Adverse Events Occurring at >2% on TIKOSYN, and Numerically More Frequently on TIKOSYN than Placebo in Patients with Supraventricular Arrhythmias

Adverse EventTIKOSYN %Placebo %
headache119
chest pain107
dizziness86
respiratory tract infection75
dyspnea65
nausea54
flu syndrome42
insomnia43
accidental injury31
back pain32
procedure (medical/surgical/health service)32
diarrhea32
rash32
abdominal pain32

Adverse events reported at a rate >2% but no more frequently on TIKOSYN than on placebo were: angina pectoris, anxiety, arthralgia, asthenia, atrial fibrillation, complications (application, injection, incision, insertion, or device), hypertension, pain, palpitation, peripheral edema, supraventricular tachycardia, sweating, urinary tract infection, ventricular tachycardia.

The following adverse events have been reported with a frequency of ≤2% and numerically more frequently with TIKOSYN than placebo in patients with supraventricular arrhythmias: angioedema, bradycardia, cerebral ischemia, cerebrovascular accident, edema, facial paralysis, flaccid paralysis, heart arrest, increased cough, liver damage, migraine, myocardial infarct, paralysis, paresthesia, sudden death, and syncope.

The incidences of clinically significant laboratory test abnormalities in patients with supraventricular arrhythmias were similar for patients on TIKOSYN and those on placebo. No clinically relevant effects were noted in serum alkaline phosphatase, serum GGT, LDH, AST, ALT, total bilirubin, total protein, blood urea nitrogen, creatinine, serum electrolytes (calcium, chloride, glucose, magnesium, potassium, sodium), or creatine kinase. Similarly, no clinically relevant effects were observed in hematologic parameters.

In the DIAMOND population, adverse events other than those related to the post-infarction and heart failure patient population were generally similar to those seen in the supraventricular arrhythmia groups.

Read the entire FDA prescribing information for Tikosyn (Dofetilide)

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© Tikosyn Patient Information is supplied by Cerner Multum, Inc. and Tikosyn Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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