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Remimazolam Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 15, 2022.

For the Consumer

Applies to remimazolam: intravenous powder for solution

Warning

Intravenous route (Powder for Solution)

Warning: Personnel and Equipment for Monitoring and Resuscitation, and Risks from Concomitant Use with Opioid Analgesics and Other Sedative-HypnoticsOnly personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer remimazolam.Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation.Remimazolam has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and through the recovery period.Resuscitative drugs, and age-and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of remimazolam.Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous remimazolam can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.

Side effects requiring immediate medical attention

Along with its needed effects, remimazolam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking remimazolam:

More common

  • Blurred vision
  • chest pain or discomfort
  • confusion
  • dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • nausea
  • nervousness
  • pounding in the ears
  • sweating
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting

Less common

  • Body aches or pain
  • chills
  • cough
  • ear congestion
  • fever
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat

Get emergency help immediately if any of the following symptoms of overdose occur while taking remimazolam:

Symptoms of overdose

  • Difficulty sleeping
  • disorientation
  • drowsiness to profound loss of consciousness
  • irregular, fast or slow, or shallow breathing
  • mood or other mental changes
  • pale or blue lips, fingernails, or skin
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual drowsiness, dullness, or feeling of sluggishness

For Healthcare Professionals

Applies to remimazolam: intravenous powder for injection

General

The most commonly reported side effects included hypotension, hypertension, bradycardia, and tachycardia.[Ref]

Cardiovascular

Bradycardia occurred in up to 50% of patients undergoing colonoscopy given over 150 mcg fentanyl concomitantly.

Diastolic hypertension occurred in up to 30% of patients undergoing bronchoscopy given up to 100 mcg fentanyl concomitantly.

Diastolic hypotension occurred in up to 21% of patients undergoing bronchoscopy given between 100 to 150 mcg fentanyl concomitantly.

Hypertension occurred in up to 72% of patients undergoing bronchoscopy given over 150 mcg fentanyl concomitantly. Hypertension was defined by an increase in diastolic blood pressure (BP) of at least 100 mmHg, systolic BP of at least 180 mmHg, at least a 20% diastolic or systolic increase over baseline OR patients requiring medical intervention.

Hypertension occurred in up to 100% of patients undergoing colonoscopy given over 150 mcg fentanyl concomitantly. Hypotension was defined by a decrease in diastolic BP of 40 mmHg or lower, systolic BP of 80 mmHg or lower, at least a 20% diastolic or systolic decrease below baseline, OR patients requiring medical intervention.

Systolic hypotension occurred in up to 26% of patients undergoing bronchoscopy given up to 100 mcg fentanyl concomitantly.

Tachycardia occurred in up to 50% of patients undergoing colonoscopy given over 150 mcg fentanyl concomitantly.[Ref]

Very common (10% or more): Hypotension (up to 100%), hypertension (up to 72%), bradycardia (up to 50%), tachycardia (up to 50%), diastolic hypertension (up to 30%), systolic hypertension (up to 26%), diastolic hypotension (up to 21%)

Common (1% to 10%): Blood pressure increased, diastolic blood pressure increased, systolic blood pressure increased[Ref]

Respiratory

Hypoxia occurred in up to 36% of patients undergoing colonoscopy given over 150 mcg fentanyl concomitantly.

Increased respiratory rate occurred in up to 36% of patients undergoing colonoscopy given over 150 mcg fentanyl concomitantly.

Respiratory acidosis occurred in up to 19% of patients with American Society of Anesthesiologists Physical Status (ASA-PS) III and IV undergoing colonoscopy.[Ref]

Very common (10% or more): Hypoxia (up to 36%), respiratory rate increased (up to 36%), respiratory acidosis (up to 19%)

Common (1% to 10%): Respiratory rate decreased, upper respiratory tract infection[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Other

Common (1% to 10%): Pyrexia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Byfavo (remimazolam)." Acacia Pharma, Inc, Indianapolis, IN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.