Rythmol
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Rythmol
Rythmol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Medical Editor: John P. Cunha, DO, FACOEP
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
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
Adverse reactions associated with propafenone HCl occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of patients treated with propafenone HCl have discontinued treatment because of adverse reactions.
Adverse reactions reported for > 1.5% of 474 SVT patients who received propafenone in U.S. clinical trials are presented in the following table by incidence and percent discontinuation, reported to the nearest percent.
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% |
Results of controlled trials in ventricular arrhythmia patients comparing adverse reaction rates on propafenone and placebo, and on propafenone and quinidine are shown in the following table. Adverse reactions reported for ≥ 1% of the patients receiving propafenone as shown, unless they were more frequent on placebo than propafenone. The most common events 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.
Adverse Reactions Reported for ≥ 1% of Ventricular Arrhythmia
Patients
| Prop./Placebo Trials | Prop./Quinidine Trials | |||
| Prop. | Placebo | Prop. | Quinidine | |
| (N=247) | (N=111) | (N=53) | (N=52) | |
| Unusual Taste | 7% | 1% | 23% | 0% |
| Dizziness | 7% | 5% | 15% | 10% |
| First Degree AV Block | 5% | 1% | 2% | 0% |
| Headache(s) | 5% | 5% | 2% | 8% |
| Constipation | 4% | 0% | 6% | 2% |
| Intraventricular Conduction Delay | 4% | 0% | - | - |
| Nausea and/or Vomiting | 3% | 1% | 6% | 15% |
| Fatigue | - | - | 4% | 2% |
| Palpitations | 2% | 1% | - | - |
| Blurred Vision | 2% | 1% | 6% | 2% |
| Dry Mouth | 2% | 1% | 6% | 6% |
| Dyspnea | 2% | 3% | 4% | 0% |
| Abdominal | - | - | 2% | 8% |
| Pain/Cramps | ||||
| Dyspepsia | - | - | 2% | 8% |
| CHF | - | - | 2% | 0% |
| Fever | - | - | 2% | 10% |
| Tinnitus | - | - | 2% | 2% |
| Vision, Abnormal | - | - | 2% | 2% |
| Esophagitis | - | - | 2% | 0% |
| Gastroenteritis | - | - | 2% | 0% |
| Anxiety | 2% | 2% | - | - |
| Anorexia | 2% | 1% | 0% | 2% |
| Proarrhythmia | 1% | 0% | 2% | 0% |
| Flatulence | 1% | 0% | 2% | 0% |
| Angina | 1% | 0% | 2% | 4% |
| Second Degree AV Block | 1% | 0% | - | - |
| Bundle Branch Block | 1% | 0% | 2% | 2% |
| Loss of Balance | 1% | 0% | - | - |
| Diarrhea | 1% | 1% | 6% | 39% |
Adverse reactions reported for ≥ 1% of 2,127 ventricular arrhythmia patients who received propafenone in U.S. clinical trials are presented in the following table by propafenone daily dose. The most common adverse reactions in controlled clinical trials 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. The principal causes of discontinuation were the most common events and are shown in the table.
Adverse Reactions Reported for ≥ 1% of Ventricular Arrhythmia
Patients
N=2127
| Incidence by Total Daily Dose |
Total Incidence |
% of Pts. Who Discont. |
|||
| 450 mg | 600 mg | ≥ 900 mg | |||
| (N=1430) | (N=1337) | (N=1333) | (N=2127) | ||
| Dizziness | 4% | 7% | 11% | 13% | 2.4% |
| Nausea and/or Vomiting | 2% | 6% | 9% | 11% | 3.4% |
| Unusual Taste | 3% | 5% | 6% | 9% | 0.7% |
| Constipation | 2% | 4% | 5% | 7% | 0.5% |
| Fatigue | 2% | 3% | 4% | 6% | 1.0% |
| Dyspnea | 2% | 2% | 4% | 5% | 1.6% |
| Proarrhythmia | 2% | 2% | 3% | 5% | 4.7% |
| Angina | 2% | 2% | 3% | 5% | 0.5% |
| Headache(s) | 2% | 3% | 3% | 5% | 1.0% |
| Blurred Vision | 1% | 2% | 3% | 4% | 0.8% |
| CHF | 1% | 2% | 3% | 4% | 1.4% |
| Ventricular Tachycardia | 1% | 2% | 3% | 3% | 1.2% |
| Dyspepsia | 1% | 2% | 3% | 3% | 0.9% |
| Palpitations | 1% | 2% | 3% | 3% | 0.5% |
| Rash | 1% | 1% | 2% | 3% | 0.8% |
| AV Block, First Degree | 1% | 1% | 2% | 3% | 0.3% |
| Diarrhea | 1% | 2% | 2% | 3% | 0.6% |
| Weakness | 1% | 2% | 2% | 2% | 0.7% |
| Dry Mouth | 1% | 1% | 1% | 2% | 0.2% |
| Syncope/Near Syncope | 1% | 1% | 1% | 2% | 0.7% |
| QRS Duration, Increased | 1% | 1% | 2% | 2% | 0.5% |
| Chest Pain | 1% | 1% | 1% | 2% | 0.2% |
| Anorexia | 1% | 1% | 2% | 2% | 0.4% |
| Abdominal | |||||
| Pain, Cramps | 1% | 1% | 1% | 2% | 0.4% |
| Ataxia | 0% | 1% | 2% | 2% | 0.2% |
| Insomnia | 0% | 1% | 1% | 2% | 0.3% |
| Premature Ventricular Contraction(s) | 1% | 1% | 1% | 2% | 0.1% |
| Bradycardia | 1% | 1% | 1% | 2% | 0.5% |
| Anxiety | 1% | 1% | 1% | 2% | 0.6% |
| Edema | 1% | 0% | 1% | 1% | 0.2% |
| Tremor(s) | 0% | 1% | 1% | 1% | 0.3% |
| Diaphoresis | 1% | 0% | 1% | 1% | 0.3% |
| Bundle Branch Block | 0% | 1% | 1% | 1% | 0.5% |
| Drowsiness | 1% | 1% | 1% | 1% | 0.2% |
| Atrial Fibrillation | 1% | 1% | 1% | 1% | 0.4% |
| Flatulence | 0% | 1% | 1% | 1% | 0.1% |
| Hypotension | 0% | 1% | 1% | 1% | 0.4% |
| Intraventricular Conduction Delay | 0% | 1% | 1% | 1% | 0.1% |
| Pain, Joints | 0% | 0% | 1% | 1% | 0.1% |
In addition, the following adverse reactions were reported less frequently than 1% either in clinical trials or in marketing experience (adverse events for marketing experience are given in italics). 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, apnea, coma, confusion, depression, memory loss, numbness, paresthesias, psychosis/mania, seizures (0.3%), tinnitus, unusual smell sensation, vertigo.
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. Cholestasis (0.1%), elevated liver enzymes (alkaline phosphatase, serum transaminases) (0.2%), gastroenteritis, hepatitis (0.03%).
Hematologic: Agranulocytosis, anemia, bruising, granulocytopenia, increased bleeding time, leukopenia, purpura, thrombocytopenia.
Other: Alopecia, eye irritation, hyponatremia/inappropriate ADH secretion, impotence, increased glucose, kidney failure, positive ANA (0.7%), lupus erythematosis, muscle cramps, muscle weakness, nephrotic syndrome, pain, pruritus.
Read the entire FDA prescribing information for Rythmol (Propafenone) »
Additional Rythmol Information
Rythmol - User Reviews
Rythmol User Reviews
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Here is a collection of user reviews for the medication Rythmol sorted by most helpful.
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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