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Brevibloc (Esmolol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reaction rates are based on use of BREVIBLOC (Esmolol Hydrochloride) in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials. Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important and common adverse effect has been hypotension [see Warnings and Precautions]. Deaths have been reported in post-marketing experience occurring during complex clinical states where BREVIBLOC was presumably being used to control ventricular rate [see Warnings and Precautions].

Clinical Trial Adverse Reactions (Frequency <3%)

Psychiatric Disorders

Confusional state and agitation (~2%)

Anxiety, depression and abnormal thinking (<1%)

Nervous System Disorders

Headache (~ 2%)

Paresthesia, syncope, speech disorder, and lightheadedness (<1%)

Convulsions (<1%), with one death

Vascular Disorders

Peripheral ischemia (~1%)

Pallor and flushing (<1%)

Gastrointestinal Disorders

Vomiting (~1%)

Dyspepsia, constipation, dry mouth, and abdominal discomfort (<1%)

Renal and Urinary Disorders

Urinary retention (<1%)

Post-Marketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been reported in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.

Cardiac Disorders

Cardiac arrest, Coronary arteriospasm

Skin and Subcutaneous Tissue Disorders

Angioedema, Urticaria, Psoriasis



REPORTS OF SUSPECTED BREVIBLOC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Brevibloc. The information is not vetted and should not be considered as verified clinical evidence.

Possible Brevibloc side effects / adverse reactions in 16 year old male

Reported by a pharmacist from United States on 2011-10-11

Patient: 16 year old male weighing 123.0 kg (270.6 pounds)

Reactions: Heart Rate Decreased, Drug Intolerance, Cerebrovascular Accident, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-27

Brevibloc
    Start date: 2011-09-29
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-03

Brevibloc
    Start date: 2011-10-03

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-28

Brevibloc
    Start date: 2011-09-29
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-26

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-03

Atenolol
    Administration route: Oral
    Indication: Tachycardia
    Start date: 2011-09-30

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-27

Brevibloc
    Start date: 2011-09-27
    End date: 2011-09-28

Brevibloc
    Start date: 2011-09-27
    End date: 2011-09-28

Brevibloc
    Start date: 2011-09-29
    End date: 2011-09-29

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-28

Brevibloc
    Start date: 2011-10-03

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-29

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-29

Brevibloc
    Indication: Ventricular Arrhythmia
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Indication: OFF Label USE
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-29
    End date: 2011-09-29

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02



Possible Brevibloc side effects / adverse reactions in 16 year old male

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

Patient: 16 year old male weighing 123.0 kg (270.6 pounds)

Reactions: Heart Rate Decreased, Drug Intolerance, Cerebrovascular Accident, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-29

Brevibloc
    Start date: 2011-09-29
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-27
    End date: 2011-09-28

Brevibloc
    Start date: 2011-09-29
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-03

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-26

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-27

Brevibloc
    Start date: 2011-09-29
    End date: 2011-09-29

Brevibloc
    Start date: 2011-09-29
    End date: 2011-09-29

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-03

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-29

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-03

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-26
    End date: 2011-09-27

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-28

Brevibloc
    Start date: 2011-09-28
    End date: 2011-09-28

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-02

Brevibloc
    Start date: 2011-10-02
    End date: 2011-10-03

Brevibloc
    Indication: OFF Label USE
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Indication: Ventricular Arrhythmia
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-23
    End date: 2011-09-23

Brevibloc
    Start date: 2011-09-27
    End date: 2011-09-28

Atenolol
    Administration route: Oral
    Indication: Tachycardia
    Start date: 2011-09-30



Possible Brevibloc side effects / adverse reactions in 82 year old female

Reported by a pharmacist from United States on 2012-02-28

Patient: 82 year old female weighing 67.6 kg (148.7 pounds)

Reactions: Extravasation, Soft Tissue Injury

Adverse event resulted in: hospitalization

Suspect drug(s):
Brevibloc

Other drugs received by patient: Zosyn; Lovenox; Pepcid; Insulin



See index of all Brevibloc side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-18

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