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Common Side Effects of Rythmol (Propafenone) Drug Center


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8.14.2017 | Logan Miers
Rythmol
Common Side Effects of Rythmol (Propafenone) Drug Center

Adverse reactions reported for > 1.5% of 474 SVT patients who received RYTHMOL in U.S. clinical trials are presented in Table 1 by incidence and percent discontinuation, reported to the nearest percent.

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Nervous System: Abnormal dreams, abnormal speech, abnormal vision, confusion, depression, memory loss, numbness, paresthesias, psychosis / mania, seizures (0.3%), tinnitus, unusual smell sensation, vertigo.

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Rythmol passes into breast milk and may have undesirable effects on a nursing infant. During pregnancy, Rythmol should be used only when prescribed. Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day). l your doctor all medications and supplements you use. The initial dose of Rythmol is 150 mg given every eight hours (450 mg/day). Consult your doctor before breastfeeding. Rythmol may interact with cimetidine, digoxin, ketoconazole, orlistat, quinidine, rifampin, blood thinners, antidepressant, HIV or AIDS medication, other heart rhythm medications, medicines to treat psychiatric disorders, or beta-blockers.

Table 1: Adverse Reactions Reported for > 1.5% of SVT Patients Incidence (N = 480) % of Pts. Who Discontinued Unusual Taste 14% 1.3% Nausea and/or Vomiting 11% 2.9% Dizziness 9% 1.7% Constipation 8% 0.2% Headache 6% 0.8% Fatigue 6% 1.5% Blurred Vision 3% 0.6% Weakness 3% 1.3% Dyspnea 2% 1.0% Wide Complex Tachycardia 2% 1.9% CHF 2% 0.6% Bradycardia 2% 0.2% Palpitations 2% 0.2% Tremor 2% 0.4% Anorexia 2% 0.2% Diarrhea 2% 0.4% Ataxia 2% 0.0%.

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.

Causality and relationship to propafenone therapy cannot necessarily be judged from these events. In addition, the following adverse reactions were reported less frequently than 1% either in clinical trials or in marketing experience.

In controlled trials in patients with ventricular arrhythmia, the most common reactions reported for RYTHMOL and more frequent than on placebo were unusual taste, dizziness, first degree AV block, intraventricular conduction delay, nausea and/or vomiting, and constipation. Headache was relatively common also, but was not increased compared to placebo. Other reactions reported more frequently than on placebo or comparator and not already reported elsewhere included anxiety, angina, second degree AV block, bundle branch block, loss of balance, congestive heart failure, and dyspepsia.

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Gastrointestinal: A number of patients with liver abnormalities associated with propafenone therapy have been reported in post-marketing experience. Some appeared due to hepatocellular injury, some were cholestatic and some showed a mixed picture. One case was rechallenged with a positive outcome. Some of these reports were simply discovered through clinical chemistries, others because of clinical symptoms including fulminant hepatitis and death.

Less serious side effects may include:

Other: Alopecia, eye irritation, impotence, increased glucose, positive ANA (0.7%), muscle cramps, muscle weakness, nephrotic syndrome, pain, pruritus.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of RYTHMOL.

Our Rythmol (propafenone hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Read the entire detailed patient monograph for Rythmol (Propafenone).

Blood and Lymphatic System: Increased bleeding time.

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Read the Rythmol User Reviews »

Immune System: lupus erythematosis.

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.

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Nervous System: Apnea, coma.

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Renal and Urinary: Hyponatremia /inappropriate ADH secretion, kidney failure.

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.

Hematologic: Agranulocytosis, anemia, bruising, granulocytopenia, leukopenia, purpura, thrombocytopenia.

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Some less common reactions may also have been dose-related such as first degree AV block, congestive heart failure, dyspepsia, and weakness. Adverse reactions reported for ≥ 1% of 2,127 ventricular arrhythmia patients who received propafenone in U.S. clinical trials were evaluated by daily dose. The most common adverse reactions appeared dose-related (but note that most patients spent more time at the larger doses), especially dizziness, nausea and/or vomiting, unusual taste, constipation, and blurred vision. Other adverse reactions included rash, syncope, chest pain, abdominal pain, ataxia, and hypotension.

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About 20% of patients treated with RYTHMOL have discontinued treatment because of adverse reactions. Adverse reactions associated with RYTHMOL occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems.

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Gastrointestinal: Cholestasis, elevated liver enzymes (alkaline phosphatase, serum transaminases), gastroenteritis, hepatitis.

Cardiovascular System: Atrial flutter, AV dissociation, cardiac arrest, flushing, hot flashes, sick sinus syndrome, sinus pause or arrest, supraventricular tachycardia.

Read the entire FDA prescribing information for Rythmol (Propafenone).

Rythmol (propafenone hydrochloride) is a Class IC anti-arrhythmic used to prevent serious heart rhythm disorders. Rythmol is available in generic form. Common side effects of Rythmol include:.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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

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