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Rythmol SR (Propafenone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rythmol SR (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 (40)
Death (3)
Disability (2)

Reports by Reaction Type

Drug Ineffective (8)Asthenia (6)Fall (5)Product Quality Issue (5)Headache (4)Balance Disorder (4)Cerebrovascular Accident (4)Sensory Loss (3)Fatigue (3)Dizziness (3)Hypoaesthesia (3)Arrhythmia (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Rythmol SR (Propafenone). For a complete list or a specific selection of reports, please use the links above.

Possible Rythmol SR side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 69 year old female

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Lisinopril and Hydrochlorothiazide; Diltiazem



Possible Rythmol SR side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 78 year old male

Reactions: Heart Rate Decreased, Drug Administration Error, Conduction Disorder

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Aspirin; Fish OIL; Flax Seed; Simvastatin; Vitamin D; Cyproheptadine HCL; Glucosamine; Miralax; Levothyroxine Sodium; Lisinopril; Acidophilus; Multivitamin



Possible Rythmol SR side effects in 29 year old male

Reported by a physician from United States on 2012-06-22

Patient: 29 year old male, weighing 71.3 kg (156.8 pounds)

Reactions: Electrocardiogram PR Prolongation, Heart Rate Irregular, Atrioventricular Block Second Degree

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 78 year old male

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: 78 year old male

Reactions: Heart Rate Decreased, Wrong Technique in Drug Usage Process, Conduction Disorder, Intentional Drug Misuse

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Simvastatin; Vitamin D; Miralax; Multivitamin; Lisinopril; Flax Seed; Levothyroxine Sodium; Aspirin; Cyproheptadine HCL; Fish OIL; Glucosamine; Acidophilus



Possible Rythmol SR side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: 81 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Rythmol SR
    Dosage: 225mg unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Ventolin HFA
    Indication: Product Used FOR Unknown Indication



Possible Rythmol SR side effects in

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: , weighing 79.5 kg (174.9 pounds)

Reactions: Weight Decreased, Pruritus, Eye Irritation, Upper-Airway Cough Syndrome, Somnolence, Photophobia, Product Quality Issue, Blood Urine Present, Dysphagia, Stomatitis, Nausea, Underdose, Poor Quality Drug Administered, Eye Pain, Dysgeusia, Blood Glucose Decreased, Bladder Spasm, Vaginal Inflammation, Alopecia, DRY Eye, Asthenia

Drug(s) suspected as cause:
Rythmol SR
    Indication: Product Used FOR Unknown Indication

Zofran
    Indication: Product Used FOR Unknown Indication



Possible Rythmol SR side effects in 80 year old female

Reported by a physician from United States on 2012-04-26

Patient: 80 year old female

Reactions: Lymphadenopathy, Pneumonitis

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Ramipril; Metoprolol Tartrate; Synthroid



Possible Rythmol SR side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-03-23

Patient: 47 year old male

Reactions: Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-03-19

Patient: 70 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Spinal Compression Fracture, Balance Disorder, Fall

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-03-14

Patient: 69 year old male

Reactions: Therapeutic Response Decreased, Fatigue, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Prilosec; Potassium; Lisinopril



Possible Rythmol SR side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-13

Patient: male

Reactions: Fatigue, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Potassium; Lisinopril; Prilosec



Possible Rythmol SR side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: 69 year old female

Reactions: Cardiac Flutter, Atrial Fibrillation

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Propafenone HCL



Possible Rythmol SR side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-28

Patient: male

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Lisinopril; Prilosec; Potassium Chloride



Possible Rythmol SR side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-02-20

Patient: 77 year old male

Reactions: Renal Failure, General Physical Health Deterioration, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Vitamin D; Lisinopril; Amaryl; Amitriptyline HCL; Fish OIL; Sodium Bicarbonate; M.v.i.; Insulin; Aspirin; Toprol-XL



Possible Rythmol SR side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-02-03

Patient: 69 year old female

Reactions: Balance Disorder, Sensory Loss, Hypoaesthesia, Headache, Cerebrovascular Accident, Asthenia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Vitamin TAB; Hydrocodone Bitartrate; Premarin; Xanax; Levothyroxine Sodium; Citalopram Hydrobromide



Possible Rythmol SR side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-01-31

Patient: 77 year old male

Reactions: Renal Failure, General Physical Health Deterioration, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Amaryl; Vitamin D; Amitriptyline HCL; Lisinopril; Fish OIL; Sodium Bicarbonate; Aspirin; Toprol-XL; M.v.i.; Insulin



Possible Rythmol SR side effects in female

Reported by a pharmacist from United States on 2012-01-18

Patient: female

Reactions: Spinal Compression Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: 69 year old female

Reactions: Balance Disorder, Sensory Loss, Hypoaesthesia, Headache, Fall, Cerebrovascular Accident, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Citalopram; Premarin; Vitamin TAB; Xanax; Levothyroxine Sodium; Hydrocodone Bitartrate



Possible Rythmol SR side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-20

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2011-12-16

Patient: 69 year old female

Reactions: Balance Disorder, Sensory Loss, Hypoaesthesia, Headache, Asthenia, Cerebrovascular Accident, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Xanax; Vitamin TAB; Citalopram; Hydrocodone Bitartrate; Premarin; Levothyroxine Sodium



Possible Rythmol SR side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-11-17

Patient: 60 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-02

Patient: female

Reactions: Palpitations, Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 70 year old male

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Propafenone Hydrochloride
    Indication: Arrhythmia

Rythmol SR
    Dosage: 325mg twice per day
    Administration route: Oral
    Indication: Arrhythmia

Other drugs received by patient: Proscar



Possible Rythmol SR side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 72 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Propafenone Hydrochloride
    Administration route: Oral
    Indication: Atrial Fibrillation

Rythmol SR
    Dosage: 325mg twice per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-08-01



Possible Rythmol SR side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 67 year old male

Reactions: Cardioversion, Dyspnoea, Drug Ineffective, Hypotension, Abasia, Hyperhidrosis, Overdose, Heart Rate Decreased, Drug Administration Error, Dizziness, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Blood Pressure Medication
    Administration route: Oral
    Indication: Blood Pressure

Rhythmol
    Dosage: 1tab three times per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-03-29

Rythmol SR
    Dosage: 225mg three times per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-03-15
    End date: 2011-03-27

Other drugs received by patient: Zocor; Coumadin



Possible Rythmol SR side effects in 69 year old male

Reported by a physician from United States on 2011-11-02

Patient: 69 year old male, weighing 170.0 kg (374.0 pounds)

Reactions: Normochromic Normocytic Anaemia

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Digoxin; Crestor



Possible Rythmol SR side effects in 83 year old female

Reported by a pharmacist from United States on 2011-11-02

Patient: 83 year old female

Reactions: Ejection Fraction Decreased

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Amiodarone HCL



Possible Rythmol SR side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 68 year old female

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Propafenone Hydrochloride
    Administration route: Oral
    Indication: Supraventricular Tachycardia

Rythmol SR
    Administration route: Oral
    Indication: Supraventricular Tachycardia
    Start date: 2008-01-01

Other drugs received by patient: Synthroid



Possible Rythmol SR side effects in 62 year old female

Reported by a physician from United States on 2011-11-02

Patient: 62 year old female, weighing 100.5 kg (221.1 pounds)

Reactions: Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rythmol SR



Possible Rythmol SR side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2011-11-02

Patient: 64 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Rythmol SR

Other drugs received by patient: Actos; Vitamin B Complex CAP; Alpha Lipoic Acid; Lantus; L-Lysine; Mineral Supplement; Amlodipine Besylate; Levothyroxine Sodium; Coumadin; Citalopram Hydrobromide; Essential Fatty Acids; CO-Q10; Multi-Vitamin; Magnesium

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