Adverse Reactions
Adverse reactions associated with propafenone HCI occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of patients treated with propafenone HCI 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
Pain/Cramps | - | - | 2% | 8% |
| 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
Fibrilation | 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 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.
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REPORTS OF SUSPECTED RYTHMOL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Rythmol. The information is not vetted and should not be considered as verified clinical evidence.
Possible Rythmol side effects / adverse reactions in 77 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-02
Patient: 77 year old male
Reactions: Dysgeusia, Constipation
Suspect drug(s):
Rythmol
Indication: Product Used FOR Unknown Indication
Rythmol SR
Dosage: 225mg twice per day
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-05-09
Other drugs received by patient: Lipitor; Antihypertensive; Aspirin
Possible Rythmol side effects / adverse reactions in 50 year old female
Reported by a physician from Canada on 2011-12-12
Patient: 50 year old female
Reactions: Bradyarrhythmia, Pulse Absent
Adverse event resulted in: hospitalization
Suspect drug(s):
Altace
Dosage: 5 mg
Administration route: Oral
Indication: Hypertension
Start date: 2010-11-02
End date: 2011-01-27
Blinded Therapy
Dosage: unk
Indication: non-Small Cell Lung Cancer
Start date: 2011-01-05
End date: 2011-01-05
Rythmol
Dosage: 300 mg, unk
Administration route: Oral
Indication: Palpitations
Start date: 2008-10-01
Tenormin
Dosage: 100 mg, unk
Administration route: Oral
Indication: Hypertension
Start date: 2009-11-15
Other drugs received by patient: Indapamide; Arepanrix H1n1
Possible Rythmol side effects / adverse reactions in 50 year old female
Reported by a consumer/non-health professional from Belgium on 2011-12-12
Patient: 50 year old female
Reactions: Heart Rate Decreased, Palpitations, Bradyarrhythmia
Adverse event resulted in: hospitalization
Suspect drug(s):
Altace
Dosage: 5 mg, 1x/day
Administration route: Oral
Indication: Hypertension
Start date: 2010-11-02
End date: 2011-01-27
Altace
Dosage: 1.25 mg, 2x/day
Start date: 2011-01-27
Blinded Therapy
Dosage: unk
Indication: non-Small Cell Lung Cancer
Start date: 2011-01-05
End date: 2011-01-05
Rythmol
Dosage: 300 mg, unk
Administration route: Oral
Indication: Palpitations
Start date: 2008-10-01
Tenormin
Dosage: 100 mg, unk
Administration route: Oral
Indication: Hypertension
Start date: 2009-11-15
Other drugs received by patient: Indapamide; Arepanrix H1n1
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