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Brand Name: Tikosyn®
Active Ingredient:   dofetilide
Strength(s): 125mcg, 250mcg, & 500mcg
Dosage Form(s):   Capsules
Company Name:    Pfizer Inc.
Prescription only
*Date Approved by FDA:   October 4, 2022
*Approval by FDA does not mean that the drug is
available for consumers at this time.

Do Not Buy Tikosyn Over the Internet

  • You should not buy Tikosyn over the Internet because you will
    bypass important safeguards designed to protect your health (and the
    health of others).
  • Tikosyn has special safety restrictions on how it is distributed
    to the public. Also, drugs

    purchased from foreign Internet sources are not the FDA-approved
    versions of the drugs, and

    they are not subject to FDA-regulated manufacturing controls or FDA
    inspection of manufacturing facilities. 

To learn more about buying drugs safely, please see 

  • Buying
    Prescription Medicines Online: A Consumer Safety Guide.
  • FDA
    strengthens controls, issues consumer alert on importing certain
    prescription drugs
  • FDA
    Import Alert


What is Tikosyn used for?

Tikosyn is a medicine that is given to
patients with irregular heartbeats (atrial fibrillation). Tikosyn may help the heart beat
more regularly and stay beating regularly for a longer period of time.

Who should not take Tikosyn?

You should not take Tikosyn if you:

Are taking certain other medicines, including:

  • cimetidine (TAGAMET, TAGAMET HB)®, used to
    treat heartburn, upset stomach, and stomach ulcers, available both by prescription and
    without a prescription
  • verapamil (CALAN, CALAN SR, COVERA-HS, ISOPTIN, ISOPTIN SR, VERELAN, VERELAN PM)®, used to treat high blood pressure and certain heart problems
  • ketoconazole (NIZORAL)®, used to treat
    certain fungus infections
  • trimethoprim alone (PROLOPRIM, TRIMPEX)® or
    the combination of trimethoprim and sulfamethoxazole (BACTRIM, SEPTRA)®, used to treat certain bacterial infections
  • prochlorperazine (COMPAZINE)®, used to
    treat nausea and vomiting
  • megestrol (MEGACE)®, used to treat certain
    types of cancer or loss of appetite
  • and weight loss associated with AIDS

Have serious kidney problems or are on kidney dialysis.

Special Warning(s) with Tikosyn:

In some patients, Tikosyn can cause a different type of abnormal heartbeat that
can be dangerous and in rare cases even cause death. The different type of heartbeat may
be a fast beating of the heart with lightheadedness and fainting. The possibility of this
different type of abnormal heartbeat is the reason you and your doctor have discussed
whether your symptoms are troublesome enough for you to start taking Tikosyn.

General Precautions with Tikosyn:

Tell your doctor about any problems you have with your:

  • heart
  • kidneys
  • liver

 What should I tell my doctor or health care provider?

Be sure to tell your health care provider about all prescription and
non-prescription medicines you are taking, as well as vitamins, dietary supplements, and
any natural or herbal remedies.

Taking certain other medications with Tikosyn can increase the amount of Tikosyn
in your body and cause the different type of abnormal heartbeat, including medicines used
to treat:

Tell your health care provider if you are pregnant or breast-feeding a child.

What are some possible side effects of Tikosyn? (This is NOT
a complete list of side effects reported with Tikosyn. Your health care provider can
discuss with you a more complete list of side effects.

Tikosyn’s most serious side effect, the different type of dangerous
abnormal heartbeat is described in the "Special Warnings" section.

Other common side effects of Tikosyn are:

  • Headache
  • Chest pain
  • Dizziness

For more detailed information about Tikosyn, ask your health care

http://www.fda.gov/cder/foi/appletter/1999/20931ltr.pdf    Tikosyn’s
approved label and patient information 

Posted: 12/12/00

Updated: 6/18/01

Revised 7/11/01


Back to Drug Side Effects

source: FDA

last update: December 2004

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