Rythmol SR Side Effects

Generic Name: Propafenone

Please note - some side effects for Rythmol SR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rythmol SR - for the consumer

Rythmol SR Sustained-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rythmol SR Sustained-Release Capsules:

Change in taste; constipation; dizziness; drowsiness; gas; lightheadedness; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; chills; excessive thirst; fast, slow, or irregular heartbeat; fever; loss of appetite; muscle weakness; prolonged diarrhea; shortness of breath; sore throat; sweating; swelling of the hands or feet; tremor; unexplained weakness; unusual bruising or bleeding; vomiting.

For the professional

Rythmol SR

Of the total number of subjects in Phase III clinical studies of Rythmol SR (propafenone hydrochloride) 45.7 percent were 65 and over, while 15.7 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals at higher doses cannot be ruled out. The effect of age on the pharmacokinetics and pharmacodynamics of propafenone has not been studied.

No clinically important differences in incidence of adverse reactions were noted by age, or gender. Too few non-White 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 propafenone SR treatment groups and not listed in Table 2 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 in Table 3 include the following adverse events by body and preferred term.

BLOOD AND LYMPHATIC SYSTEM DISORDERS:  Anemia, lymphadenopathy, spleen disorder, thrombocytopenia.

CARDIAC DISORDERS: Angina unstable, arrhythmia, atrial hypertrophy, atrioventricular block, bundle branch block, bunch branch block left, bundle branch block right, cardiac arrest, cardiac disorder, conduction disorder, coronary artery disease, extrasystoles, myocardial infarction, nodal arrhythmia, palpitations, pericarditis, sinoatrial block, sinus arrest, sinus arrhythmia, sinus bradycardia, supraventricular extrasystoles, supraventricular tachycardia, ventricular arrhythmia, 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, dry throat, 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 electrocardiogram, abnormal heart sounds, abnormal liver function tests, 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, electrocardiogram QT prolonged, glycosuria present, heart rate irregular, 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, pruritis, 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 vasucal disease, thrombosis.

Laboratory

Propafenone prolongs the PR and QRS intervals in patients with atrial and ventricular arrythmias. Prolongation of the QRS interval makes it difficult to interpret the effect of propafenone on the QT interval.

In RAFT, the distribution of the maximum changes in QTc compared to baseline over the study in each patient was similar in the Rythmol SR 225 mg BID, 325 mg BID, and 425 mg BID and placebo dose groups. Similar results were seen in the ERAFT study.

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