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Tambocor

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Tambocor

Tambocor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tambocor (flecainide acetate) is prescribed in certain situations to prevent serious heart rhythm disorders such as serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). It is also used to prevent certain types of irregular heartbeat from returning (such as atrial fibrillation). Tambocor is in a group of drugs called anti-arrhythmics. This medication is available in generic form. Common side effects include dizziness, vision problems, shortness of breath, headache, nausea, shaking, tiredness, or weakness.

The first few doses of Tambocor are administered in a hospital setting in case the medication causes serious side effects. Tell your doctor all medications you are taking. Tambocor may have adverse interactions with many other medications. Interactions may occur with cimetidine, digoxin, diuretics, seizure medications, beta blockers, other heart rhythm medications, and other drugs. During pregnancy, this medication should be used only when needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk. However, this drug is considered unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Our Tambocor 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tambocor in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • dizziness, fainting, fast or pounding heartbeat;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • pale skin, easy bruising or bleeding, unusual weakness; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness;
  • tremor or shaking;
  • headache;
  • anxiety or depression;
  • vision problems;
  • nausea, vomiting, stomach pain;
  • diarrhea, constipation; or
  • numbness or tingling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tambocor (Flecainide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tambocor Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Dizziness, vision problems (such as blurred vision, problems focusing, seeing spots), shortness of breath, headache, nausea, shaking, tiredness, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).

Seek immediate medical attention if any of these rare but serious side effects occur: faster/more irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tambocor (Flecainide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tambocor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, TAMBOCOR (flecainide) therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group. (See WARNINGS.)

Adverse effects reported for TAMBOCOR (flecainide) , described in detail in the Warnings section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF; and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, TAMBOCOR (flecainide) treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest). (See WARNINGS.) New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias. There have also been instances of second- (0.5%) or third-degree (0.4%) AV block. Patients have developed sinus bradycardia, sinus pause, or sinus arrest, about 1.2% altogether (see WARNINGS). The frequency of most of these serious adverse events probably increases with higher trough plasma levels, especially when these trough levels exceed 1.0μg/mL.

There have been rare reports of isolated elevations of serum alkaline phosphatase and isolated elevations of serum transaminase levels. These elevations have been asymptomatic and no cause and effect relationship with TAMBOCOR (flecainide) has been established. In foreign postmarketing surveillance studies, there have been rare reports of hepatic dysfunction including reports of cholestasis and hepatic failure, and extremely rare reports of blood dyscrasias. Although no cause and effect relationship has been established, it is advisable to discontinue TAMBOCOR (flecainide) in patients who develop unexplained jaundice or signs of hepatic dysfunction or blood dyscrasias in order to eliminate TAMBOCOR (flecainide) as the possible causative agent.

Incidence figures for other adverse effects in patients with ventricular arrhythmias are based on a multicenter efficacy study, utilizing starting doses of 200 mg/day with gradual upward titration to 400 mg/day. Patients were treated for an average of 4.7 months, with some receiving up to 22 months of therapy. In this trial, 5.4% of patients discontinued due to non-cardiac adverse effects.

Table 1 Most Common Non-Cardiac Adverse Effects in Ventricular Arrhythmia Patients Treated with TAMBOCOR (flecainide) in the Multicenter Study

Adverse Effect Incidence
All 429 Patients at Any Dose
Incidence by Dose During Upward Titration
200
mg/Day
(N=426)
300
mg/Day
(N=293)
400
mg/Day
(N=100)
Dizziness* 18.9% 11.0% 10.6% 13.0%
Visual Disturbances† 15.9% 5.4% 12.3% 18.0%
Dyspnea 10.3% 5.2% 7.5% 4.0%
Headache 9.6% 4.5% 6.1% 9.0%
Nausea 8.9% 4.9% 4.8% 6.0%
Fatigue 7.7% 4.5% 4.4% 3.0%
Palpitation 6.1% 3.5% 2.4% 7.0%
Chest Pain 5.4% 3.1% 3.8% 1.0%
Asthenia 4.9% 2.6% 2.0% 4.0%
Tremor 4.7% 2.4% 3.4% 2.0%
Constipation 4.4% 2.8% 2.1% 1.0%
Edema 3.5% 1.9% 1.4% 2.0%
Abdominal Pain 3.3% 1.9% 2.4% 1.0%
* Dizziness includes reports of dizziness, lightheadedness, faintness, unsteadiness, near syncope, etc.
†Visual disturbance includes reports of blurred vision, difficulty in focusing, spots before eyes, etc.

The following additional adverse experiences, possibly related to TAMBOCOR (flecainide) therapy and occurring in 1% to less than 3% of patients, have been reported in acute and chronic studies: Body as a Whole- malaise, fever; Cardiovascular- tachycardia, sinus pause or arrest; Gastrointestinal- vomiting, diarrhea, dyspepsia, anorexia; Skin- rash; Visual- diplopia; Nervous System- hypoesthesia, paresthesia, paresis, ataxia, flushing, increased sweating, vertigo, syncope, somnolence, tinnitus; Psychiatric- anxiety, insomnia, depression.

The following additional adverse experiences, possibly related to TAMBOCOR (flecainide) , have been reported in less than 1% of patients: Body as a Whole- swollen lips, tongue and mouth; arthralgia, bronchospasm, myalgia; Cardiovascular- angina pectoris, seconddegree and third-degree AV block, bradycardia, hypertension, hypotension; Gastrointestinal- flatulence; Urinary System- polyuria, urinary retention; Hematologic- leukopenia, granulocytopenia, thrombocytopenia; Skin- urticaria, exfoliative dermatitis, pruritis, alopecia; Visual- eye pain or irritation, photophobia, nystagmus; Nervous System- twitching, weakness, change in taste, dry mouth, convulsions, impotence, speech disorder, stupor, neuropathy; Respiratory- pneumonitis/pulmonary infiltration possibly due to chronic flecainide treatment; Psychiatric- amnesia, confusion, decreased libido, depersonalization, euphoria, morbid dreams, apathy. For patients with supraventricular arrhythmias, the most commonly reported noncardiac adverse experiences remain consistent with those known for patients treated with TAMBOCOR (flecainide) for ventricular arrhythmias. Dizziness is possibly more frequent in PAF patients.

Read the entire FDA prescribing information for Tambocor (Flecainide) »

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Tambocor - User Reviews

Tambocor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tambocor sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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