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Rythmol SR

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Rythmol SR

Rythmol SR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rythmol SR (propafenone hydrochloride) is used in certain situations to prevent serious heart rhythm disorders. It is a Class IC anti-arrhythmic. 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 starting dose of Rythmol SR is 225 mg every 12 hours. Dosage may be increased by your doctor at a minimum of 5-day intervals to 325 mg every 12 hours, or if prescribed up to 425 mg every 12 hours. Rythmol SR may interact with cimetidine, digoxin, ketoconazole, orlistat, quinidine, rifampin, blood thinners, antidepressants, HIV or AIDS medications, other heart rhythm medications, medicine to treat psychiatric disorders, or beta-blockers. Tell your doctor all medications and supplements you use. During pregnancy, Rythmol SR should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Rythmol SR (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 SR 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 SR (Propafenose Hydrochloride Extended Release Capsules) »

What is Patient Information Overview?

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

Rythmol SR 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 SR (Propafenose Hydrochloride Extended Release Capsules)»

What is Prescribing information?

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

Rythmol SR 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.

The data described below reflect exposure to RYTHMOL SR 225 mg BID in 126 patients, to RYTHMOL SR 325 mg BID in 135 patients, to RYTHMOL SR 425 mg BID in 136 patients, and to placebo in 126 patients for up to 39 weeks (mean 20 weeks) in a placebo-controlled trial (RAFT) conducted in the US. The most commonly reported adverse events with propafenone ( > 5% and greater than placebo), excluding those not reasonably associated with the use of the drug or because they were associated with the condition being treated, were dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. The frequency of discontinuation due to adverse events was 17%, and the rate was highest during the first 14 days of treatment.

Cardiac-related adverse events occurring in ≥ 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: angina pectoris, atrial flutter, AV block first degree, bradycardia, congestive cardiac failure, cardiac murmur, edema, dyspnea, rales, wheezing, and cardioactive drug level above therapeutic.

Propafenone prolongs the PR and QRS intervals in patients with atrial and ventricular arrhythmias. Prolongation of the QRS interval makes it difficult to interpret the effect of propafenone on the QT interval [see CLINICAL PHARMACOLOGY].

Non-cardiac related adverse events occurring in ≥ 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: blurred vision, constipation, diarrhea, dry mouth, flatulence, nausea, vomiting, fatigue, weakness, upper respiratory tract infection, blood alkaline phosphatase increased, hematuria, muscle weakness, dizziness (excluding vertigo), headache, taste disturbance, tremor, somnolence, anxiety, depression, ecchymosis.

No clinically important differences in incidence of adverse reactions were noted by age or gender. Too few non-Caucasian patients were enrolled to assess adverse events according to race.

Adverse events occurring in 2% or more of the patients in any of the ERAFT [see Clinical Studies] propafenone SR treatment groups and not listed above include the following: bundle branch block left, bundle branch block right, conduction disorders, sinus bradycardia, and hypotension.

Other adverse events reported with propafenone clinical trials not already listed elsewhere in the prescribing information include the following adverse events by body and preferred term.

Blood and lymphatic system disorders: Anemia, lymphadenopathy, spleen disorder, thrombocytopenia.

Cardiac disorders: Unstable angina, atrial hypertrophy, cardiac arrest, coronary artery disease, extrasystoles, myocardial infarction, nodal arrhythmia, palpitations, pericarditis, sinoatrial block, sinus arrest, sinus arrhythmia, supraventricular extrasystoles, ventricular extrasystoles, ventricular hypertrophy.

Ear and labyrinth disorders: Hearing impaired, tinnitus, vertigo.

Eye disorders: Eye hemorrhage, eye inflammation, eyelid ptosis, miosis, retinal disorder, visual acuity reduced.

Gastrointestinal disorders: Abdominal distension, abdominal pain, duodenitis, dyspepsia, dysphagia, eructation, gastritis, gastroesophageal reflux disease, gingival bleeding, glossitis, glossodynia, gum pain, halitosis, intestinal obstruction, melena, mouth ulceration, pancreatitis, peptic ulcer, rectal bleeding, sore throat.

General disorders and administration site conditions: Chest pain, feeling hot, hemorrhage, malaise, pain, pyrexia.

Hepato-biliary disorders: Hepatomegaly.

Investigations: Abnormal heart sounds, abnormal pulse, carotid bruit, decreased blood chloride, decreased blood pressure, decreased blood sodium, decreased hemoglobin, decreased neutrophil count, decreased platelet count, decreased prothrombin level, decreased red blood cell count, decreased weight, glycosuria present, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, increased blood cholesterol, increased blood creatinine, increased blood glucose, increased blood lactate dehydrogenase, increased blood pressure, increased blood prolactin, increased blood triglycerides, increased blood urea, increased blood uric acid, increased eosinophil count, increased gamma-glutamyltransferase, increased monocyte count, increased prostatic specific antigen, increased prothrombin level, increased weight, increased white blood cell count, ketonuria present, proteinuria present.

Metabolism and nutrition disorders: Anorexia, dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypokalemia.

Musculoskeletal, connective tissue and bone disorders: Arthritis, bursitis, collagen-vascular disease, costochondritis, joint disorder, muscle cramps, muscle spasms, myalgia, neck pain, pain in jaw, sciatica, tendonitis.

Nervous system disorders: Amnesia, ataxia, balance impaired, brain damage, cerebrovascular accident, dementia, gait abnormal, hypertonia, hypothesia, insomnia, paralysis, paresthesia, peripheral neuropathy, speech disorder, syncope, tongue hypoesthesia.

Psychiatric disorders: Decreased libido, emotional disturbance, mental disorder, neurosis, nightmare, sleep disorder.

Renal and urinary disorders: Dysuria, nocturia, oliguria, pyuria, renal failure, urinary casts, urinary frequency, urinary incontinence, urinary retention, urine abnormal.

Reproductive system and breast disorders: Breast pain, impotence, prostatism.

Respiratory, thoracic and mediastinal disorders: Atelectasis, breath sounds decreased, chronic obstructive airways disease, cough, epistaxis, hemoptysis, lung disorder, pleural effusion, pulmonary congestion, rales, respiratory failure, rhinitis, throat tightness.

Skin and subcutaneous tissue disorders: Alopecia, dermatitis, dry skin, erythema, nail abnormality, petechiae, pruritus, sweating increased, urticaria.

Vascular disorders: Arterial embolism limb, deep limb venous thrombosis, flushing, hematoma, hypertension, hypertensive crisis, hypotension, labile blood pressure, pallor, peripheral coldness, peripheral vascular disease, thrombosis.

Read the entire FDA prescribing information for Rythmol SR (Propafenose Hydrochloride Extended Release Capsules) »

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Rythmol SR - User Reviews

Rythmol SR 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 SR 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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