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Remimazolam Side Effects

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. "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.