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Tonocard Side Effects Center
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.
Tonocard in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop taking tocainide and seek emergency medical attention:
- an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
- a new or a worsening irregular heartbeat pattern;
- wheezing, coughing, chest pain, or chest discomfort;
- unusual bruising or bleeding; or
- fever, sore throat, a sore mouth, mouth ulcers, or an infection.
Other, less serious side effects may be more likely to occur. Continue to take tocainide and talk to your doctor if you experience
- dizziness or tiredness;
- upset stomach, vomiting, decreased appetite, or diarrhea;
- headache or blurred vision;
- confusion; or
- numbness, tingling, or tremor (shaking).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Tonocard (Tocainide HCl) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tonocard FDA Prescribing Information: Side Effects
TONOCARD (tocainide hcl) commonly produces minor, transient, nervous system and gastrointestinal adverse reactions, but is otherwise generally well tolerated. TONOCARD (tocainide hcl) has been evaluated in both short-term (n = 1,358) and long-term (n = 262) controlled studies as well as a compassionate use program. Dosages were lower in most of the controlled studies (1200 mg/day) and higher in the compassionate use program (1800 mg and more). In long-term (2-6 months) controlled studies, the most frequent adverse reactions were dizziness/vertigo (15.3 percent), nausea, (14.5 percent), paresthesia (9.2 percent), and tremor (8.4 percent). These reactions were generally mild, transient, dose-related and reversible with a reduction in dosage, by taking the drug with food, or by therapy discontinuation. Tremor, when present, may be useful as a clinical indicator that the maximum dose is being approached. Adverse reactions leading to therapy discontinuation occurred in 21 percent of patients in long-term controlled trials and were usually related to the nervous system or digestive system.
Adverse reactions occurring in greater than one percent of patients from the short-term and long-term controlled studies appear in the following table:
|Body System / |
| Percent of Patients |
|Short-term (n=1,358)||Long-term (n=262)|
|BODY AS A WHOLE|
|Left ventricular failure||1.4||0.0|
|Diarrhea/ loose stools||0.0||3.8|
|Blurred vision/visual disturbances||1.3||1.5|
An additional group of about 2,000 patients has been treated in a program allowing for the use of TONOCARD (tocainide hcl) under compassionate use circumstances. These patients were seriously ill with the large majority on multiple drug therapy, and comparatively high doses of TONOCARD (tocainide hcl) were used. Fifty-four percent of the patients continued in the program for one year or longer, and 12 percent were treated for longer than three years, with the longest duration of therapy being nine years. Adverse reactions leading to therapy discontinuation occurred in 12 percent of patients (usually central nervous system effects or rash). A tabulation of adverse reactions occurring in one percent or more of patients follows:
|Body System / |
|Percent of Patients Compassionate Use (n=1,927)|
|Increased ventricular arrhythmias/PVCs|| |
|CHF/progression of CHF|| |
|Conduction disorders|| |
|Rash/Skin lesion|| |
|Blurred vision/vision disturbances||10.0|
Adverse reactions occurring in less than one percent of patients, in either the controlled studies on the compassionate use program or since the drug was marketed, are as follows:
Cardiovascular: Ventricular fibrillation; extension of acute myocardial infarction; cardiogenic shock; pulmonary embolism; angina; AV block; hypertension; claudication; increased QRS duration; pleurisy/pericarditis; prolonged QT interval; right bundle branch block; cardiomegaly; sinus arrest; vasculitis; orthostatic hypotension; cold extremities.
Digestive: Hepatitis, jaundice (see PRECAUTlONS), abnormal liver function tests, pancreatitis, abdominal pain and discomfort; constipation; dysphagia; gastrointestinal symptoms (including dyspepsia); stomatitis; dry mouth; thirst.
Nervous System/Psychiatric: Coma; convulsions/seizures; myasthenia gravis; depression; psychosis; psychic disturbances; agitation; decreased mental acuity; dysarthria; impaired memory; increased stuttering/slurred speech; insomnia/sleeping disturbances; local anesthesia; dream abnormalities.
Agranulocytosis, bone marrow depression, leukopenia, neutropenia, aplastic/hypoplastic anemia, and thrombocytopenia have been reported (0.18 percent) in patients receiving TONOCARD (tocainide hcl) in controlled trials and the compassionate use program. Most of these events have been noted during the first 12 weeks of therapy. (See Boxed WARNINGS.)
Pulmonary fibrosis, interstitial pneumonitis, fibrosing alveolitis, pulmonary edema, and pneumonia, have been reported in patients receiving TONOCARD. (tocainide hcl) The incidence of pulmonary fibrosis (including interstitial pneumonitis and fibrosing alveolitis) was 0.11 percent in controlled trials and the compassionate use program. These events usually occurred in seriously ill patients. Symptoms of these pulmonary disorders and/or x-ray changes usually occurred following 3-18 weeks of therapy. Fatalities have been reported. (See Boxed WARNINGS.)
A number of disorders, in which a causal relationship with TONOCARD (tocainide hcl) has not been established, have been reported in seriously ill patients. These include: renal failure; renal dysfunction; myocardial infarction; cerebrovascular accidents and transient ischemic attacks. These disorders may be related to the patient†s underlying condition.
DRUG ABUSE AND DEPENDENCE
Read the entire FDA prescribing information for Tonocard (Tocainide HCl) »
Additional Tonocard Information
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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