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Rythmol

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Rythmol

Rythmol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rythmol (propafenone hydrochloride) is a Class IC anti-arrhythmic used to prevent serious heart rhythm disorders. This medication is available in generic form. Common side effects include dizziness, headache, metallic/salty taste in the mouth, nausea/vomiting, constipation, anxiety, and tiredness.

The initial dose of Rythmol is 150 mg given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day). 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. Tell your doctor all medications and supplements you use. During pregnancy, Rythmol should be used only when prescribed. Rythmol passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

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.

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.

Rythmol 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:

  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • chest pain, rapid heart rate, pounding heartbeats or fluttering in your chest;
  • fever, chills, sore throat, flu symptoms, weakness;
  • confusion, unusual thoughts or behavior;
  • seizure; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, anxiety, loss of balance or coordination;
  • unusual or unpleasant taste in your mouth;
  • nausea, vomiting, constipation, loss of appetite;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • tired feeling;
  • ringing in your ears;
  • unusual dreams; or
  • blurred vision.

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.

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

What is Patient Information Overview?

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

Rythmol Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Dizziness, headache, metallic/salty taste in the mouth, nausea/vomiting, constipation, anxiety, and tiredness 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 rare but very serious side effects occur: signs of infection (such as high fever, severe chills, weakness, persistent sore throat), signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine), 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: fainting, faster/more irregular heartbeat, severe dizziness.

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 Rythmol (Propafenone)»

What is Prescribing information?

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

Rythmol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

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.

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

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.

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%

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.

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. Some less common reactions may also have been dose-related such as first degree AV block, congestive heart failure, dyspepsia, and weakness. Other adverse reactions included rash, syncope, chest pain, abdominal pain, ataxia, and hypotension.

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

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

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

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

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

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

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RYTHMOL. 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.

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. Some of these reports were simply discovered through clinical chemistries, others because of clinical symptoms including fulminant hepatitis and death. One case was rechallenged with a positive outcome.

Blood and Lymphatic System: Increased bleeding time

Immune System: lupus erythematosis

Nervous System: Apnea, coma

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

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

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Rythmol - User Reviews

Rythmol 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 Rythmol 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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