This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Betapace (Sotalol) 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 (23)
Reports by Reaction Type
Atrial Fibrillation (9),
Headache (3),
Cardiac Pacemaker Insertion (3),
Nasopharyngitis (2),
Oedema Peripheral (2),
Blood Pressure Increased (2),
Hypotension (2),
Heart Rate Decreased (2),
Insomnia (2),
Bradycardia (2),
Extrasystoles (1),
Drug Interaction (1)
Possible Betapace side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 71 year old female
Reactions: Fatigue, Vomiting, Extrasystoles, Heart Rate Increased, Feeling Hot, Suicidal Ideation
Drug(s) suspected as cause:
Betapace
Dosage: 80 mg, qd
Indication: Hypertension
Betapace
Dosage: 40 mg, qd
Other drugs received by patient: Spironolactone; Aspirin; Dronedarone HCL
Possible Betapace side effects in
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient:
Reactions: Drug Interaction
Drug(s) suspected as cause:
Betapace
Other drugs received by patient possibly interacting with the suspect drug:
Celebrex
Possible Betapace side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: 67 year old female, weighing 67.1 kg (147.7 pounds)
Reactions: Headache
Drug(s) suspected as cause:
Betapace
Dosage: 80 mg, bid
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Xarelto
Indication: Cerebrovascular Accident Prophylaxis
Xarelto
Dosage: 20 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-01
End date: 2012-05-15
Other drugs received by patient: Verapamil; Propranolol Hydrochloride; Crestor
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female, weighing 67.1 kg (147.7 pounds)
Reactions: Headache
Drug(s) suspected as cause:
Betapace
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-01
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-01
End date: 2012-05-15
Other drugs received by patient: Propranolol HCL Retard; Verapamil; Crestor
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: female
Reactions: Oedema Peripheral, Insomnia, Atrial Fibrillation, Dizziness, Hyperthyroidism
Drug(s) suspected as cause:
Betapace
Other drugs received by patient: Carvedilol
Possible Betapace side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: 68 year old female
Reactions: Oedema Peripheral, Atrial Fibrillation, Viral Myocarditis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betapace
Dosage: 160 mg daily
Indication: Atrial Fibrillation
Start date: 2001-04-01
Sotalol HCL
Dosage: 80 mg
Indication: Atrial Fibrillation
Start date: 2001-03-01
End date: 2001-04-01
Other drugs received by patient: Accupril; Pravachol; Paxil; Valium; Coumadin; Multi-Vitamins; MAG-OX
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: female
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: male
Reactions: Nasopharyngitis, Heart Rate Decreased, Cardiac Pacemaker Insertion, Hypotension, Bradycardia
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: 56 year old female
Reactions: Arrhythmia, Muscle Spasms
Drug(s) suspected as cause:
Betapace AF
Dosage: 80 mg, daily
Administration route: Oral
Indication: Ventricular Arrhythmia
Betapace
Indication: Ventricular Arrhythmia
Possible Betapace side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-03-20
Patient: 65 year old female
Reactions: Abdominal Discomfort
Drug(s) suspected as cause:
Dabigatran
Betapace
Dosage: 80 mg, unk
Administration route: Oral
Start date: 2011-10-03
Possible Betapace side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: male
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Betapace
Other drugs received by patient: Tikosyn
Possible Betapace side effects in 73 year old male
Reported by a individual with unspecified qualification from United States on 2012-03-16
Patient: 73 year old male, weighing 118.0 kg (259.6 pounds)
Reactions: Pneumonia, Sudden Cardiac Death, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-15
Patient: female
Reactions: Palpitations, Atrial Fibrillation
Drug(s) suspected as cause:
Betapace
Other drugs received by patient: Sotalol HCL
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-15
Patient: female
Reactions: Blood Pressure Increased, Blood Pressure Systolic Increased, Chest Pain, Headache, Blood Pressure Diastolic Decreased
Drug(s) suspected as cause:
Betapace
Dosage: 80 mg, bid
Indication: Hypertension
Start date: 2010-01-01
End date: 2011-12-01
Betapace
Dosage: unk
Betapace
Dosage: 80 mg, bid
Start date: 2011-12-01
Betapace
Dosage: 120 mg, tid
End date: 2012-01-09
Possible Betapace side effects in 55 year old female
Reported by a physician from United States on 2012-02-15
Patient: 55 year old female, weighing 145.0 kg (319.0 pounds)
Reactions: Angioedema
Drug(s) suspected as cause:
Xarelto
Dosage: 20 mg, qd
Administration route: Oral
Start date: 2011-11-21
End date: 2011-11-25
Flecainide
Dosage: 150 mg, bid
Indication: Atrial Fibrillation
Start date: 2011-11-25
End date: 2011-11-30
Betapace
Indication: Atrial Fibrillation
Start date: 2011-11-11
End date: 2011-11-25
Other drugs received by patient: Metoprolol Tartrate; Torsemide; Potassium Chloride; Ibuprofen; Acetylsalicylic Acid SRT; Pepcid AC
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-25
Patient: female
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Betapace
Other drugs received by patient: Toprol-XL; Cardizem
Possible Betapace side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-10
Patient: male
Reactions: Cardiac Pacemaker Insertion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betapace
Dosage: unk
Start date: 2011-07-01
Betapace
Dosage: unk
Possible Betapace side effects in 71 year old female
Reported by a consumer/non-health professional from United States on 2011-12-20
Patient: 71 year old female
Reactions: Blood Pressure Increased, Insomnia, Nervousness
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: female
Reactions: Atrial Fibrillation
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: male
Reactions: Heart Rate Decreased, Nasopharyngitis, Cardiac Pacemaker Insertion, Hypotension, Bradycardia
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: female
Reactions: Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betapace
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: female
Reactions: Cardiac Pacemaker Replacement, Atrial Fibrillation
Drug(s) suspected as cause:
Betapace AF
Dosage: unk
End date: 2011-07-01
Betapace
Dosage: unk
Start date: 2011-06-01
Possible Betapace side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-21
Patient: female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Betapace AF
Betapace
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