Brevibloc Side Effects

Generic Name: esmolol

Please note - some side effects for Brevibloc may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Brevibloc - for the Consumer

Brevibloc

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Brevibloc:

Agitation; confusion; dizziness; drowsiness; headache; nausea; sleepiness.

Seek medical attention right away if any of these SEVERE side effects occur when using Brevibloc:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in skin color; chest pain; fainting; headache; mental/mood changes; pain, redness, or swelling at the injection site; seizures; sweating; unusually slow or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Brevibloc Side Effects - for the Professional

Brevibloc

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 adverse effect has been hypotension. Deaths have been reported in post-marketing experience occurring during complex clinical states where Brevibloc was presumably being used simply to control ventricular rate.

Cardiovascular

Symptomatic hypotension (diaphoresis, dizziness) occurred in 12% of patients, and therapy was discontinued in about 11%, about half of whom were symptomatic. Asymptomatic hypotension occurred in about 25% of patients. Hypotension resolved during Brevibloc (Esmolol Hydrochloride) infusion in 63% of these patients and within 30 minutes after discontinuation of infusion in 80% of the remaining patients. Diaphoresis accompanied hypotension in 10% of patients. Peripheral ischemia occurred in approximately 1% of patients. Pallor, flushing, bradycardia (heart rate less than 50 beats per minute), chest pain, syncope, pulmonary edema and heart block have each been reported in less than 1% of patients. In two patients without supraventricular tachycardia but with serious coronary artery disease (post inferior myocardial infarction or unstable angina), severe bradycardia/sinus pause/asystole has developed, reversible in both cases with discontinuation of treatment.

Central Nervous System

Dizziness has occurred in 3% of patients; somnolence in 3%; confusion, headache, and agitation in about 2%; and fatigue in about 1% of patients. Paresthesia, asthenia, depression, abnormal thinking, anxiety, anorexia, and lightheadedness were reported in less than 1% of patients. Seizures were also reported in less than 1% of patients, with one death.

Respiratory

Bronchospasm, wheezing, dyspnea, nasal congestion, rhonchi, and rales have each been reported in less than 1% of patients.

Gastrointestinal

Nausea was reported in 7% of patients. Vomiting has occurred in about 1% of patients. Dyspepsia, constipation, dry mouth, and abdominal discomfort have each occurred in less than 1% of patients. Taste perversion has also been reported.

Skin (Infusion Site)

Infusion site reactions including inflammation and induration were reported in about 8% of patients. Edema, erythema, skin discoloration, burning at the infusion site, thrombophlebitis, and local skin necrosis from extravasation have each occurred in less than 1% of patients.

Miscellaneous

Each of the following has been reported in less than 1% of patients: Urinary retention, speech disorder, abnormal vision, midscapular pain, rigors, and fever.

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Side Effects by Body System - for Healthcare Professionals

General

Effects and side effects of esmolol are usually brief and transient because of the relatively short half-life of esmolol (approximately 9 minutes).

Cardiovascular

Significant reductions of left and right ventricular ejection fractions, increases in pulmonary capillary wedge pressure, and decreases in cardiac output have been reported in patients with a mean left ventricular (LV) ejection fraction of 0.27. None of these changes were clinically significant, but the investigators advise cautious monitoring of the hemodynamic status in patients with LV dysfunction, especially at dosages greater than 200 mcg per kg per min.

Cardiovascular side effects are the most common. Symptomatic (diaphoresis or dizziness) and asymptomatic hypotension occur in up to 14% and 50% of patients, respectively. Hypotension is more likely with dosages greater than 200 mcg per kg per min. Peripheral ischemia, pallor, flushing, chest pain, syncope, bradycardia, pulmonary edema, and heart block have been reported in less than 1% of patients. Hemodynamic changes are reported in patients with left ventricular dysfunction.

Nervous system

Nervous system side effects include dizziness, weakness, somnolence or headache in 3% to 7% of patients. Paresthesias, anorexia, asthenia, lightheadedness, agitation and general irritability occur in less than 1% of patients. One fatal seizure associated with esmolol is reported.

Gastrointestinal

Gastrointestinal complaints are mainly limited to nausea in 6% of patients. Dyspepsia, general abdominal discomfort, dry mouth, and vomiting are reported in less than 1% of patients.

Respiratory

Respiratory system side effects including bronchospasm, dyspnea, wheezing nasal congestion, rhonchi, and rales have been reported in less than 1% of patients. As with other beta-adrenergic receptor antagonists, esmolol should be given cautiously, if at all, to patients with a reactive airways disease.

Local

Local intravenous site reactions including inflammation and induration have been reported (approximately 8%). Edema, erythema, skin discoloration, burning, thrombophlebitis, and local skin necrosis have been reported in less than 1% of patients.

Psychiatric

Psychiatric side effects including depression and abnormal thinking have been rarely reported (<1%).

Genitourinary

Genitourinary effects including urinary retention have been rarely reported (<1%).

Other

Other side effects including speech disorder, abnormal vision, midscapular pain, rigors, and fever have been reported rarely (<1%).

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