IMPORTANT SAFETY INFORMATION AND INDICATION
Do not take TIKOSYN if you have congenital or acquired long QT syndrome (a disorder of the heartbeat which may be present from birth, or it may be acquired as a result of certain medical conditions or from taking certain medications. People with long QT syndrome may have symptoms including an unusually rapid heartbeat, fainting, and seizures. Sudden cardiac death may also result from long QT syndrome); have serious kidney problems or are on kidney dialysis; are taking certain other medicines, including cimetidine (Tagamet®, Tagamet HB®), verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin®, Isoptin SR®, Verelan®, Verelan PM®), ketoconazole (Nizoral®), trimethoprim alone (Proloprim®, Trimpex®), the combination of trimethoprim and sulfamethoxazole (Bactrim®, Septra®), prochlorperazine (Compazine®), megestrol (Megace®), dolutegravir (Tivicay®) or hydrochlorothiazide alone or in combination with other medicines (such as Esidrix®, Ezide®, Hydrodiuril®, Hydro-Par®, Microzide®, or Oretic®); or are allergic to dofetilide or other ingredients in TIKOSYN.
The most common side effects of TIKOSYN are headache, chest pain, and dizziness. TIKOSYN can also cause other side effects. If you are concerned about these or any other side effects, ask your doctor.
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TIKOSYN® (dofetilide) is a medicine for highly symptomatic atrial fibrillation or atrial flutter (irregular heartbeats). TIKOSYN may help by converting the irregular heartbeats to normal rhythm. It may also help by keeping the normal rhythm for a longer period of time. It has not been shown to work on certain types of irregular heartbeats that may come and go on their own.
Please see Full Prescribing Information, including BOXED WARNING, and Medication Guide.
Patients should always ask their doctors for medical advice about adverse events.
You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call