Tikosyn Side Effects
Generic Name: dofetilide
Please note - some side effects for Tikosyn 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 Tikosyn - for the Consumer
Tikosyn
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 Tikosyn:
Seek medical attention right away if any of these SEVERE side effects occur when using Tikosyn:Dizziness; headache; nausea; respiratory tract infection.
TopSevere 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.
Tikosyn Side Effects - for the Professional
Tikosyn
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.
In studies of patients with supraventricular arrhythmias a total of 1346 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). The incidence of torsade de pointes in patients who were dosed according to the recommended dosing regimen 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.
| Tikosyn Dose | Placebo | ||||
|---|---|---|---|---|---|
| Arrhythmia event: | <250 mcg BID N=217 |
250 mcg BID N=388 |
>250–500 mcg BID N=703 |
>500 mcg BID N=38 |
N=677 |
| Ventricular arrhythmias*† | 3.7% | 2.6% | 3.4% | 15.8% | 2.7% |
| Ventricular fibrillation | 0 | 0.3% | 0.4% | 2.6% | 0.1% |
| Ventricular tachycardia† | 3.7% | 2.6% | 3.3% | 13.2% | 2.5% |
| Torsade de pointes | 0 | 0.3% | 0.9% | 10.5% | 0 |
| Various forms of block | |||||
| AV block | 0.9% | 1.5% | 0.4% | 0 | 0.3% |
| Bundle branch block | 0 | 0.5% | 0.1% | 0 | 0.1% |
| Heart block | 0 | 0.5% | 0.1% | 0 | 0.1% |
In the DIAMOND trials a total of 1511 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.
| Tikosyn | Placebo | |
|---|---|---|
| N=249 | N=257 | |
| Ventricular arrhythmias*† | 14.5% | 13.6% |
| Ventricular fibrillation | 4.8% | 3.1% |
| Ventricular tachycardia† | 12.4% | 11.3% |
| Torsade de pointes | 1.6% | 0 |
| Various forms of block | ||
| AV block | 0.8% | 2.7% |
| (Left) bundle branch block | 0 | 0.4% |
| Heart block | 1.2% | 0.8% |
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.
| Tikosyn | Placebo | |
|---|---|---|
| Adverse Event | % | % |
| headache | 11 | 9 |
| chest pain | 10 | 7 |
| dizziness | 8 | 6 |
| respiratory tract infection | 7 | 5 |
| dyspnea | 6 | 5 |
| nausea | 5 | 4 |
| flu syndrome | 4 | 2 |
| insomnia | 4 | 3 |
| accidental injury | 3 | 1 |
| back pain | 3 | 2 |
| procedure (medical/surgical/health service) | 3 | 2 |
| diarrhea | 3 | 2 |
| rash | 3 | 2 |
| abdominal pain | 3 | 2 |
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.
TopSide 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%.
Top
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
