Brevibloc Side Effects Center

Last updated on RxList: 1/26/2021
Brevibloc Side Effects Center

What Is Brevibloc?

Brevibloc Premixed (esmolol hydrochloride) Injection is a beta-blocker indicated for the rapid control of ventricular rate in patients with atrial fibrillation, or atrial flutter in perioperative, postoperative, or other emergent circumstances. Brevibloc is also indicated in noncompensatory sinus tachycardia where the rapid heart rate requires specific intervention. Brevibloc is available in generic form.

What Are Side Effects of Brevibloc?

Common side effects of Brevibloc include:

Infrequent side effects of Brevibloc include:

  • anxiety,
  • drowsiness,
  • nausea,
  • vomiting,
  • headache,
  • nervousness, and
  • redness of the face and neck.

Dosage for Brevibloc?

Dosage needs to be titrated, using ventricular rate as the guide. An initial loading dose of .5 milligrams/kg (500 micrograms/kg) infused over a minute duration followed by a maintenance infusion of .05 milligrams/kg/min (50 micrograms/kg/min) for the next 4 minutes is recommended.

What Drugs, Substances, or Supplements Interact with Brevibloc?

Brevibloc Premixed may interact with other drugs. Tell your doctor all medications and supplements you use.

Brevibloc During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Brevibloc; it is unknown if it will harm a fetus. Consult your doctor before breastfeeding.

Additional Information

Our Brevibloc Premixed (esmolol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Brevibloc Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

  • a light-headed feeling, like you might pass out;
  • very slow heartbeats;
  • swelling in your hands or feet;
  • wheezing, chest tightness, feeling short of breath;
  • weak or shallow breathing;
  • pain, swelling, irritation, bruising, or skin changes around the IV needle;
  • cold feeling in your hands and feet;
  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or
  • low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky.

Common side effects may include:

  • increased sweating;
  • nausea;
  • dizziness, drowsiness; or
  • low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Brevibloc Professional Information


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) injection 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 injection was presumably being used simply to control ventricular rate [see WARNINGS AND PRECAUTIONS].

Table 3 : Clinical Trial Adverse Reactions (Frequency ≥3%)

System Organ Class (SOC)Preferred MedDRA TermFrequency
VASCULAR DISORDERSHypotension* Asymptomatic hypotension25%
Symptomatic hypotension (hyperhidrosis, dizziness)12%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONSInfusion site reactions (inflammation and induration)8%
* Hypotension resolved during BREVIBLOC (Esmolol Hydrochloride) infusion in 63% of patients. In 80% of the remaining patients, hypotension resolved within 30 minutes following discontinuation of infusion.

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

Read the entire FDA prescribing information for Brevibloc (Esmolol)

© Brevibloc Patient Information is supplied by Cerner Multum, Inc. and Brevibloc Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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