This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rythmol (Propafenone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (39)
Death (5)
Life Threatening Events (4)
Reports by Reaction Type
Asthenia (8),
Nausea (7),
Dysgeusia (7),
Somnolence (6),
Feeling Abnormal (6),
Blood Bilirubin Increased (5),
Weight Decreased (5),
Eye Irritation (5),
Haemorrhoidal Haemorrhage (5),
Photophobia (5),
Sinusitis (5),
Blood Urine Present (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Rythmol (Propafenone). For a complete list or a specific selection of reports, please use the links above.
Possible Rythmol side effects in female
Reported by a physician from France on 2012-08-16
Patient: female
Reactions: Hepatic Function Abnormal, Cardiac Tamponade, Somnolence, Haemodynamic Instability, Death, Meningococcal Infection, Enterococcal Sepsis, Sedation, Acute Respiratory Distress Syndrome, Acute Coronary Syndrome, Renal Failure Acute, Medical Device Complication, Neurological Decompensation, Atrial Fibrillation, General Physical Health Deterioration, Staphylococcal Sepsis, Pulmonary Function Test Abnormal, Arrhythmia, Renal Impairment, Lung Disorder, Bradycardia, Electrocardiogram ST Segment Elevation, Septic Shock, Cardiac Arrest, Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Cordarone
Dosage: 600mg per day
Indication: Arrhythmia
Start date: 2012-07-07
End date: 2012-07-12
Digoxin
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-08
End date: 2012-07-08
Isoptin
Dosage: 120mg per day
Administration route: Oral
Indication: Hypertension
Start date: 2012-07-12
End date: 2012-07-12
Rythmol
Dosage: 150mg per day
Administration route: Oral
Indication: Hypertension
Start date: 2012-07-12
End date: 2012-07-12
Other drugs received by patient: Mianserine; Plavix; Lorazepam; Zocor; Aldactazine
Possible Rythmol side effects in 60 year old female
Reported by a physician from United States on 2012-08-13
Patient: 60 year old female, weighing 69.0 kg (151.8 pounds)
Reactions: Fatigue, Abasia, Dizziness, Atrial Fibrillation, Asthenia
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: NO Concurrent Medication
Possible Rythmol side effects in 85 year old female
Reported by a pharmacist from United States on 2012-07-27
Patient: 85 year old female, weighing 71.5 kg (157.2 pounds)
Reactions: Hypotension, Cardiogenic Shock, Electrocardiogram QRS Complex Prolonged, Urinary Tract Infection Bacterial, Hypoxia, Acute Respiratory Failure, Proteus Infection, Renal Failure Acute
Adverse event resulted in: death
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: Lasix; Aspirin; Amitriptyline HCL; Atenolol; Ceftriaxone; Oxycodone HCL; Centrum; Warfarin Sodium; Pacerone
Possible Rythmol side effects in female
Reported by a physician from France on 2012-07-19
Patient: female
Reactions: Intestinal Polyp, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Abnormal, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: 20mg per day
Indication: Product Used FOR Unknown Indication
Clopidogrel
Dosage: 75meq per day
Administration route: Oral
Indication: Mitral Valve Replacement
Coumadin
Dosage: .5ud per day
Administration route: Oral
Indication: Mitral Valve Replacement
End date: 2012-04-19
Rythmol
Dosage: 300mg per day
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: Lantus; Fluticasone Propionate / Salmeterol; Nicorandil; Valsartan; Furosemide; Pantoprazole; Lexomil; Ventolin
Possible Rythmol side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 61 year old female
Reactions: Gastrointestinal Haemorrhage, Polyp, RED Blood Cell Count Decreased, Rectal Haemorrhage, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: 20 mg, 1x/day
Administration route: Oral
Coumadin
Dosage: 0.5 df, 1x/day
Administration route: Oral
Indication: Mitral Valve Replacement
End date: 2012-04-01
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Mitral Valve Replacement
Rythmol
Dosage: 300 mg, 1x/day
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: Lexomil; Valsartan; Lantus; Pantoprazole; Fluticasone Propionate / Salmeterol; Adancor; Lasix; Ventolin
Possible Rythmol side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17
Patient: female
Reactions: Intestinal Polyp, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Increased, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: 20mg per day
Indication: Product Used FOR Unknown Indication
Clopidogrel
Dosage: 75mg per day
Administration route: Oral
Indication: Mitral Valve Replacement
Coumadin
Dosage: .5ud per day
Administration route: Oral
Indication: Mitral Valve Replacement
End date: 2012-04-19
Rythmol
Dosage: 300mg per day
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: Bromazepam; Nicorandil; Valsartan; Pantoprazole; Insulin Glargine; Albuterol Sulfate Autohaler; Fluticasone Propionate / Salmeterol; Furosemide
Possible Rythmol side effects in female
Reported by a physician from France on 2012-07-12
Patient: female
Reactions: Cardio-Respiratory Arrest, Suicide Attempt, Intentional Drug Misuse, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Propranolol
Dosage: 1g per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-06
Rythmol
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-06
Possible Rythmol side effects in female
Reported by a pharmacist from France on 2012-07-06
Patient: female
Reactions: Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Propranolol
Dosage: 1g per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-06
Rythmol
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-06
Possible Rythmol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22
Patient: male
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Rythmol
Possible Rythmol side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19
Patient: 65 year old female
Reactions: Weight Decreased, Blood Bilirubin Increased, Pruritus, Wrong Technique in Drug Usage Process, Treatment Noncompliance, Transaminases Increased, Blood Urine Present, Dysphagia, Stomatitis, Tablet Physical Issue, Anaemia, Poor Quality Drug Administered, Vulvovaginal Pain, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Haemorrhoidal Haemorrhage, Photophobia, Sinusitis, Nausea, Haemorrhoids, Underdose, Eye Pain, Blood Glucose Decreased, Dysgeusia, Product Packaging Issue, Disease Recurrence, Hypophagia, Alopecia, Dysuria, Feeling Abnormal, Asthenia, DRY Eye, Leukopenia
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Aspirin
Dosage: 81 mg; qd; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cozaar
Dosage: 50 mg; qd; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Nuvigil
Dosage: 50 mg; qd; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Peginterferon Alfa-2A
Dosage: qw; sc
Indication: Product Used FOR Unknown Indication
Pradaxa
Dosage: 150 mg; bid; po, 75 mg; qd; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ribavirin
Dosage: 600 mg; bid; po
Administration route: Oral
Rythmol
Dosage: 325 mg; bid; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Toprol-XL
Dosage: 50 mg; qd; po, 25 mg; qd; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Victrelis
Dosage: 800 mg; tid; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zofran
Dosage: 8 mcg; prn; po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Hydrochloride; Reglan; Metoclopramide
Possible Rythmol side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19
Patient: 65 year old female
Reactions: Blood Bilirubin Increased, Weight Decreased, Pruritus, Wrong Technique in Drug Usage Process, Treatment Noncompliance, Transaminases Increased, Dysphagia, Blood Urine Present, Stomatitis, Tablet Physical Issue, Anaemia, Poor Quality Drug Administered, Vulvovaginal Pain, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Haemorrhoidal Haemorrhage, Photophobia, Sinusitis, Nausea, Haemorrhoids, Underdose, Eye Pain, Blood Glucose Decreased, Dysgeusia, Product Packaging Issue, Disease Recurrence, Alopecia, Dysuria, Hypophagia, Feeling Abnormal, DRY Eye, Asthenia, Leukopenia
Drug(s) suspected as cause:
Aspirin
Dosage: 81 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cozaar
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Nuvigil
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Peginterferon Alfa-2A
Dosage: qw;sc
Indication: Product Used FOR Unknown Indication
Pradaxa
Dosage: 150 mg;bid;po 75 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ribavirin
Dosage: 600 mg;bid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Rythmol
Dosage: 325 mg;bid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Toprol-XL
Dosage: 50 mg;qd;po 25 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Victrelis
Dosage: 800 mg;tid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zofran
Dosage: 8 mg;prn;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Metoclopramide Hydrochloride; Reglan
Possible Rythmol side effects in female
Reported by a physician from United States on 2012-05-24
Patient: female
Reactions: Atrial Fibrillation, Asthenia
Drug(s) suspected as cause:
Levaquin
Dosage: initiated around 06-jan-2012, for 28 days
Indication: Sinusitis
Start date: 2012-01-01
Rythmol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Antacids
Possible Rythmol side effects in male
Reported by a pharmacist from France on 2012-05-11
Patient: male
Reactions: Ventricular Extrasystoles, Pneumonia, Aphasia, Pyrexia, Cerebral Ventricle Dilatation, Electroencephalogram Abnormal, Cerebellar Haematoma, Hemiplegia, Hypertension, Septic Shock, Sputum Purulent
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fluindione
Indication: Product Used FOR Unknown Indication
End date: 2012-02-09
Rythmol
Dosage: 300mg per day
Administration route: Oral
Indication: Extrasystoles
End date: 2012-02-13
Possible Rythmol side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-01
Patient: male
Reactions: Ventricular Extrasystoles, Pneumonia, Aphasia, Pyrexia, Cerebral Ventricle Dilatation, Electroencephalogram Abnormal, Cerebellar Haematoma, Hemiplegia, Hypertension, Septic Shock, Sputum Purulent
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fluindione
Indication: Product Used FOR Unknown Indication
End date: 2012-02-09
Rythmol
Dosage: 300mg per day
Administration route: Oral
Indication: Extrasystoles
End date: 2012-02-13
Possible Rythmol side effects in female
Reported by a physician from United States on 2012-04-11
Patient: female
Reactions: Atrial Fibrillation, Asthenia
Drug(s) suspected as cause:
Levaquin
Dosage: for 28 days
Indication: Sinusitis
Start date: 2012-01-23
Rythmol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Antacids
Possible Rythmol side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03
Patient: 65 year old female
Reactions: Blood Bilirubin Increased, Weight Decreased, Pruritus, Wrong Technique in Drug Usage Process, Treatment Noncompliance, Transaminases Increased, Blood Urine Present, Dysphagia, Stomatitis, Tablet Physical Issue, Anaemia, Poor Quality Drug Administered, Vulvovaginal Pain, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Haemorrhoidal Haemorrhage, Photophobia, Sinusitis, Nausea, Haemorrhoids, Underdose, Eye Pain, Blood Glucose Decreased, Dysgeusia, Product Packaging Issue, Disease Recurrence, Alopecia, Dysuria, Hypophagia, Asthenia, DRY Eye, Feeling Abnormal, Leukopenia
Drug(s) suspected as cause:
Aspirin
Dosage: 81 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cozaar
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Nuvigil
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Peginterferon Alfa-2A
Dosage: ;qw;sc
Pradaxa
Dosage: 150 mg;bid;po 75 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ribavirin
Dosage: 600 mg;bid;po
Administration route: Oral
Rythmol
Dosage: 325 mg;bid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Toprol-XL
Dosage: 50 mg;qd;po 25 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tylenol (Caplet)
Indication: Product Used FOR Unknown Indication
Victrelis
Dosage: 800 mg;tid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zofran
Dosage: 8 mg;prn;po
Administration route: Oral
Other drugs received by patient: Hydrochloride; Metoclopramide; Reglan
Possible Rythmol side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03
Patient: 65 year old female
Reactions: Blood Bilirubin Increased, Weight Decreased, Wrong Technique in Drug Usage Process, Pruritus, Treatment Noncompliance, Transaminases Increased, Blood Urine Present, Stomatitis, Dysphagia, Tablet Physical Issue, Anaemia, Poor Quality Drug Administered, Vulvovaginal Pain, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Haemorrhoidal Haemorrhage, Photophobia, Sinusitis, Nausea, Haemorrhoids, Underdose, Eye Pain, Blood Glucose Decreased, Dysgeusia, Product Packaging Issue, Disease Recurrence, Alopecia, Hypophagia, Dysuria, DRY Eye, Feeling Abnormal, Asthenia, Leukopenia
Drug(s) suspected as cause:
Aspirin
Dosage: 81 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cozaar
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Nuvigil
Dosage: 50 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Peginterferon Alfa-2A
Dosage: ;qw;sc
Indication: Product Used FOR Unknown Indication
Pradaxa
Dosage: 150 mg;bid;po 75 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Ribavirin
Dosage: 600 mg;bid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Rythmol
Dosage: 325 mg;bid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Toprol-XL
Dosage: 50 mg;qd;po 25 mg;qd;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tylenol (Caplet)
Indication: Product Used FOR Unknown Indication
Victrelis
Dosage: 800 mg;tid;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zofran
Dosage: 8 mg;prn;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Metoclopramide; Hydrochloride; Reglan
Possible Rythmol side effects in female
Reported by a consumer/non-health professional from France on 2012-03-01
Patient: female, weighing 63.0 kg (138.6 pounds)
Reactions: Grand MAL Convulsion, Abdominal Pain, Vomiting, Malaise, Hyperhidrosis, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rythmol
Possible Rythmol side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-16
Patient: 69 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Mixed Liver Injury
Drug(s) suspected as cause:
Multaq
Administration route: Oral
Start date: 2010-12-05
End date: 2010-12-15
Previscan
Administration route: Oral
Start date: 2010-12-01
End date: 2011-02-09
Rythmol
Administration route: Oral
Start date: 2010-12-16
End date: 2011-02-09
Possible Rythmol side effects in 77 year old female
Reported by a consumer/non-health professional from France on 2012-02-07
Patient: 77 year old female
Reactions: Grand MAL Convulsion, Abdominal Pain, Malaise, Vomiting, Hyperhidrosis, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rythmol
Possible Rythmol side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-25
Patient: 69 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Mixed Liver Injury
Drug(s) suspected as cause:
Multaq
Administration route: Oral
Start date: 2010-12-05
End date: 2010-12-15
Previscan
Administration route: Oral
Start date: 2010-12-01
End date: 2011-02-09
Rythmol
Administration route: Oral
Start date: 2010-12-16
End date: 2011-02-09
Possible Rythmol side effects in 50 year old female
Reported by a physician from Canada on 2011-12-29
Patient: 50 year old female
Reactions: Bradyarrhythmia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
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: Arepanrix H1n1; Indapamide
Possible Rythmol side effects in female
Reported by a physician from United States on 2011-12-28
Patient: female, weighing 103.4 kg (227.5 pounds)
Reactions: Product Substitution Issue, Dyspnoea
Drug(s) suspected as cause:
Rythmol
Possible Rythmol side effects in 50 year old female
Reported by a physician from Canada on 2011-12-27
Patient: 50 year old female
Reactions: Bradyarrhythmia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
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: Arepanrix H1n1; Indapamide
Possible Rythmol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20
Patient: female
Reactions: Heart Rate Increased
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: Metoprolol; Aspirin; Coumadin; Quinapril; Lorazepam; Crestor
Possible Rythmol side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-20
Patient: female
Reactions: Feeling Abnormal
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: NO Concurrent Medication
Possible Rythmol side effects in 81 year old female
Reported by a consumer/non-health professional from United States on 2011-12-20
Patient: 81 year old female
Reactions: Nausea
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: Enalapril Maleate; Coumadin; Lipitor; Atenolol; Omeprazole
Possible Rythmol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20
Patient: female
Reactions: Ill-Defined Disorder
Drug(s) suspected as cause:
Rythmol
Possible Rythmol side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-20
Patient: female
Reactions: Dysgeusia
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: NO Concurrent Medication
Possible Rythmol side effects in 59 year old female
Reported by a pharmacist from United States on 2011-12-20
Patient: 59 year old female
Reactions: Product Quality Issue, Dyspnoea Exertional, Dyspnoea, Drug Ineffective, Wheezing, Tachycardia, Blood Glucose Increased
Drug(s) suspected as cause:
Rythmol
Other drugs received by patient: Metformin HCL; Hydrochlorothiazide; Atenolol
|
