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Betapace AF (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 AF (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 (9)
Death (1)

Reports by Reaction Type

Hospitalisation (2)NO Adverse Event (2)Blood Creatinine Increased (2)Dyspnoea (1)Atrial Flutter (1)Drug Ineffective (1)Atrial Fibrillation (1)Muscular Weakness (1)Arrhythmia (1)Death (1)Cardiac Pacemaker Replacement (1)Muscle Spasms (1)

Possible Betapace AF side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: 73 year old female

Reactions: Dyspnoea, Atrial Flutter, Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betapace AF
    Dosage: 120 mg, bid
    Administration route: Oral
    Start date: 2012-04-01

Betapace AF
    Dosage: 80 mg, bid
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2002-01-01
    End date: 2012-04-01



Possible Betapace AF side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: male

Reactions: Hospitalisation, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betapace AF
    Dosage: daily dose 320 mg
    Administration route: Oral

Betapace AF
    Dosage: daily dose 320 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-01-01

Betapace AF
    Dosage: daily dose 160 mg
    Administration route: Oral



Possible Betapace AF side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: male

Reactions: Hospitalisation, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betapace AF
    Dosage: daily dose 160 mg
    Administration route: Oral

Betapace AF
    Dosage: daily dose 320 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2006-01-01

Betapace AF
    Dosage: daily dose 320 mg
    Administration route: Oral



Possible Betapace AF 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 AF side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-23

Patient: 49 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Betapace AF



Possible Betapace AF side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Betapace AF



Possible Betapace AF side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Betapace AF



Possible Betapace AF 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 AF 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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