Remimazolam Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.

Applies to remimazolam: intravenous powder for solution.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure this medicine is working properly and to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with you doctor right away if you have bluish lips or skin, blurred vision, choking, confusion, dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, pale skin, sweating, trouble breathing or speaking, or unusual tiredness or weakness after receiving this medicine. These could be symptoms of a serious heart or lung problem and may worsen when used with certain medicines (eg, benzodiazepine, opioid analgesic medicine).

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

Symptoms of an overdose include: change in consciousness, confusion, dizziness, faintness, or lightheadedness, hallucinations, loss of consciousness, loss of strength or energy, muscle pain or weakness, nightmares, shakiness and unsteady walk, slow or irregular heartbeat, sweating, trouble in speaking, unsteadiness, trembling, or other problems with muscle control or coordination, trouble sleeping, unusual excitement, nervousness, restlessness, or irritability, or unusual tiredness or weakness. Call your doctor right away if you notice these symptoms.

Check with your doctor before receiving this medicine with alcohol or other medicines that affect the central nervous system. The use of alcohol or other medicines that affect the CNS with remimazolam may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of remimazolam

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:

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

Symptoms of overdose

• agitation
• changes in patterns and rhythms of speech
• confusion
• difficulty sleeping
• disorientation
• drowsiness to profound loss of consciousness
• irregular, fast or slow, or shallow breathing
• loss of strength or energy
• mood or other mental changes
• nightmares
• pale or blue lips, fingernails, or skin
• seeing, hearing, or feeling things that are not there
• shakiness and unsteady walk
• slurred speech
• talkativeness
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, or feeling of sluggishness
• unusual weak feeling

For healthcare professionals

Applies to remimazolam: intravenous powder for injection.

General adverse events

The most commonly reported side effects included hypotension, hypertension, respiratory depression, diastolic hypertension, systolic hypertension, hypoxia, diastolic hypotension, and bradycardia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (included hypotension, diastolic hypotension, blood pressure decreased, systolic blood pressure decreased, diastolic blood pressure decreased; up to 100%), hypertension (up to 72%), bradycardia (included bradycardia, sinus bradycardia, heart rate decreased; 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]

In a colonoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:

Hypotension was reported in 33%, 44%, and 100% of patients, respectively.

Hypertension was reported in 16%, 24%, and 0% of patients, respectively.

Bradycardia was reported in 8%, 14%, and 50% of patients, respectively.

Diastolic hypertension was reported in 6%, 14%, and 0% of patients, respectively.

Tachycardia was reported in 7%, 8%, and 50% of patients, respectively.

Diastolic hypotension was reported in 7%, 9%, and 0% of patients, respectively.

Systolic hypertension was reported in 3%, 8%, and 0% of patients, respectively.

In a bronchoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:

Hypotension was reported in 24%, 51%, and 64% of patients, respectively.

Hypertension was reported in 20%, 40%, and 72% of patients, respectively.

Diastolic hypertension was reported in 30%, 19%, and 0% of patients, respectively.

Systolic hypertension was reported in 26%, 17%, and 4% of patients, respectively.

Diastolic hypotension was reported in 13%, 21%, and 0% of patients, respectively.

Bradycardia was reported in 1%, 6%, and 16% of patients, respectively.

Hypotension was reported as mild, moderate, and severe in 30.1%, 1.1%, and 0.1% of patients, respectively; diastolic hypotension was reported as mild in 8.7% of patients. Bradycardia was reported as mild, moderate, and severe in 6%, 0.1%, and 0.4% of patients, respectively.

In controlled trials in procedural sedation, patients 65 years and older had a higher frequency of events grouped under the term hypotension (47% vs 33.3%) than patients younger than 65 years; patients with American Society of Anesthesiologists Physical Status (ASA-PS) III to IV also showed a higher frequency for hypotension (43.6% vs 35.6%) than patients with ASA-PS I to II. Older age and higher ASA-PS were not associated with a higher frequency of bradycardia.

In a colonoscopy study, hypotension (58%), hypertension (42%), diastolic hypertension (10%), systolic hypertension (6%), bradycardia (3%), diastolic hypotension (3%), diastolic BP increased 3(%), BP increased (3%), and systolic BP increased (3%) were reported in patients with ASA-PS III and IV.^[Ref]

In clinical studies, hypotension was defined as a decrease in systolic blood pressure (BP) to 80 mmHg or lower or in diastolic BP of 40 mmHg or lower, or a decrease in systolic or diastolic BP of at least 20% below baseline or requiring medical intervention; hypertension was defined as an increase in systolic BP to at least 180 mmHg or in diastolic BP to at least 100 mmHg, or an increase of systolic or diastolic BP of at least 20% over baseline or requiring medical intervention.

Respiratory

• Very common (10% or more): Hypoxia (up to 36%), respiratory rate increased (up to 36%), respiratory acidosis (up to 19%), respiratory depression (included hypoxia, respiratory rate decreased, respiratory acidosis, bradypnea, dyspnea, oxygen saturation decreased, breath sounds abnormal, hypopnea, respiratory depression, respiratory distress; up to 13.1%)
• Common (1% to 10%): Respiratory rate decreased, upper respiratory tract infection
• Uncommon (0.1% to 1%): Hiccups^[Ref]

In a bronchoscopy study with cumulative fentanyl dose less than 100 mcg, 100 to 150 mcg, and over 150 mcg:

Hypoxia was reported in 16%, 35%, and 36% of patients, respectively.

Respiratory rate increased was reported in 10%, 19%, and 36% of patients, respectively.

Hypoxia was reported as mild, moderate, and severe in 8%, 0.9%, and 0.3% of patients, respectively. Respiratory rate decreased was reported as mild and moderate in 1.5% and 0.4% of patients, respectively.

In controlled trials in procedural sedation, patients 65 years and older had a higher frequency of events grouped under the term respiratory depression (22.8% vs 9%) than patients younger than 65 years; patients with ASA-PS III to IV also showed a higher frequency for respiratory depression (17.6% vs 11.8%) than patients with ASA-PS I to II.

In a colonoscopy study, respiratory acidosis, respiratory rate decreased, and upper respiratory tract infection were reported in 19%, 3%, and 3% of patients with ASA-PS III and IV, respectively.

Respiratory depression (hypoxia/oxygen saturation decreased) was reported in 2 of 8 subjects with moderate liver dysfunction, and 1 of 3 with severe liver dysfunction enrolled in a dedicated trial assessing this drug in liver dysfunction.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, vomiting^[Ref]

Other

• Common (1% to 10%): Pyrexia
• Uncommon (0.1% to 1%): Chills, feeling cold^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Uncommon (0.1% to 1%): Somnolence^[Ref]

See also:

Further information

Remimazolam side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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