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Betapace (Sotalol) - Side Effect Reports to FDA

 
 



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

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 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 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: 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 2012-02-15

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 2012-01-25

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 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 2011-12-08

Patient: female

Reactions: Atrial Fibrillation

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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