Versed Side Effects
Generic name: midazolam
Medically reviewed by Drugs.com. Last updated on Mar 6, 2025.
Note: This document provides detailed information about Versed.
For healthcare professionals
Applies to midazolam: compounding powder, injectable solution, intramuscular solution, intravenous solution, nasal spray, oral syrup Side Effects associated with midazolam. Some dosage forms listed on this page may not apply specifically to the brand name Versed.
For healthcare professionals
Applies to midazolam: compounding powder, injectable solution, intramuscular solution, intravenous solution, nasal spray, oral syrup.
General adverse events
The most commonly reported side effects with oral formulations include emesis and nausea. Decreased tidal volume/respiratory rate and apnea were most commonly reported with parenteral formulations.[Ref]
Respiratory
Oral:
- Very common (10% or more): Respiratory adverse events (up to 11%)
- Common (1% to 10%): Respiratory depression, hypoxia, laryngospasm, upper airway obstruction, rhonchi, congestion
- Uncommon (0.1% to 1%): Sneezing/rhinorrhea
- Frequency not reported: Apnea, hypercarbia, desaturation, stridor, hiccough
Parenteral:
- Very common (10% or more): Decreased tidal volume/respiratory rate (up to 23.3%), apnea (up to 15.4%)
- Common (1% to 10%): Hiccoughs, coughing, desaturation
- Very rare (less than 0.01%): Dyspnea, hiccup, laryngospasm, respiratory arrest
- Frequency not reported: Respiratory depression
- Postmarketing reports: Bronchospasm, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea, dysphonia, yawning, continued phonation[Ref]
Respiratory adverse events included hypoxia, laryngospasm, rhonchi, coughing, respiratory depression, airway obstruction, upper airway congestion, and shallow respirations; these side effects occurred more frequently at higher doses.
Decreased tidal volume/respiratory rate occurred in 23.3% of patients given IV formulations and in 10.8% of patients given IM formulations.
Apnea occurred in 15.4% of patients given IV formulations.[Ref]
Gastrointestinal
Oral:
- Very common (10% or more): Emesis/vomiting (up to 11%)
- Common (1% to 10%): Nausea
- Frequency not reported: Gagging, salivation
Parenteral:
- Common (1% to 10%): Nausea, vomiting
- Very rare (less than 0.01%): Constipation, dry mouth
- Postmarketing reports: Acid taste, excessive salivation, retching, toothache[Ref]
Nervous system
Oral:
- Common (1% to 10%): Sedation/prolonged sedation, somnolence, depressed levels of consciousness
- Frequency not reported: Drooling, dizziness, ataxia, vertigo, dysarthria, loss of balance
Parenteral:
- Common (1% to 10%): Headache, oversedation, drowsiness, seizure-like activity
- Very rare (less than 0.01%): Movement disorder, ataxia, dizziness, seizure, anterograde amnesia
- Frequency not reported: Involuntary movements, hyperactivity, decreased alertness, somnolence, prolonged/postoperative sedation, convulsions/drug withdrawal convulsions, feeling faint, tonic/clonic movements and muscle tremor
- Postmarketing reports: Vasovagal episode, retrograde amnesia, grogginess, athetoid movements, lethargy, slurred speech, paresthesia, loss of balance, lightheadedness, feeling of burning, emergence delirium or agitation[Ref]
Cardiovascular
Oral:
- Common (1% to 10%): Bradycardia, bigeminy
- Frequency not reported: Increased heart rate, cardiac arrest, heart failure, decreased systolic and diastolic blood pressure
Parenteral:
- Common (1% to 10%): Hypotension
- Very rare (less than 0.01%): Bradycardia, cardiac arrest, vasodilation
- Frequency not reported: Thrombophlebitis, thrombosis, variations in blood pressure and pulse rate
- Postmarketing reports: Bigeminy, premature ventricular contractions, tachycardia, nodal rhythm, hematoma, cardiovascular collapse, cardiovascular reactions, severe cardiorespiratory adverse events[Ref]
Local
Parenteral:
- Common (1% to 10%): IM injection site pain, IV site tenderness/pain during injection/redness/induration
- Uncommon (0.1% to 1%): IM injection site induration/redness/muscle stiffness, IV site phlebitis
- Frequency not reported: Injection site erythema, injection site pain
- Postmarketing reports: Hive-like elevation at injection site, warmth or coldness at injection site[Ref]
Psychiatric
Oral:
- Common (1% to 10%): Agitation
- Frequency not reported: Dysphoria, disinhibition, excitation, aggression, mood swings, hallucinations, confusion, inappropriate/adverse behavior, behavioral/emotional disorders, euphonia, libido disorders, restlessness, irritability, delusions, anger eruptions, nightmares, psychosis, physical dependency, withdrawal symptoms, abuse, depression (existing, unobserved depression)
Parenteral:
- Very rare (less than 0.01%): Aggression/aggressiveness, agitation, anger, hallucination, hostility, confusion/confusional state, euphoric mood/euphoria
- Frequency not reported: Rage, excitement/paroxysmal excitement, abuse, physical drug dependence and withdrawal syndrome
- Postmarketing reports: Argumentativeness, nervousness, anxiety, restlessness, sleep disturbance, insomnia, nightmares, dysphoria, irritability, tension, mood changes, dreaming during sleep[Ref]
Dermatologic
Oral:
- Common (1% to 10%): Rash
- Uncommon (0.1% to 1%): Pruritus and urticaria
Parenteral:
- Frequency not reported: Angioedema
- Postmarketing reports: Hives, rash, pruritus, skin reactions[Ref]
Ocular
Oral:
- Frequency not reported: Diplopia, strabismus, blurred vision
Parenteral:
- Common (1% to 10%): Nystagmus
- Postmarketing reports: Blurred vision, diplopia, pinpoint pupils, visual disturbance, difficulty focusing eyes, cyclic movement of the eyelids[Ref]
Other
Oral:
- Frequency not reported: Fatigue, falls
Parenteral:
- Common (1% to 10%): Paradoxical reaction
- Very rare (less than 0.01%): Fatigue, falls, assault/physical assault
- Postmarketing reports: Prolonged emergence from anesthesia, blocked ears, chills, weakness, swelling, dreaming during emergence[Ref]
Hypersensitivity
Oral:
- Frequency not reported: Hypersensitivity
Parenteral:
- Frequency not reported: Hypersensitivity, anaphylactic shock
- Postmarketing reports: Allergic reaction, anaphylactoid reactions[Ref]
Musculoskeletal
Oral:
- Frequency not reported: Muscle weakness, fractures
Parenteral:
- Frequency not reported: Fractures[Ref]
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References
1. (2001) "Product Information. Versed (midazolam)." Roche Laboratories
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
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Further information
Versed 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.