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Versed Side Effects

Generic Name: midazolam

Note: This page contains side effects data for the generic drug midazolam. It is possible that some of the dosage forms included below may not apply to the brand name Versed.

For the Consumer

Applies to midazolam: oral solution, oral syrup, oral tablet

Other dosage forms:

As well as its needed effects, midazolam (the active ingredient contained in Versed) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking midazolam, check with your doctor or nurse immediately:

Less common:
  • Anxiety
  • chest pain or discomfort
  • choking
  • confusion
  • difficult or troubled breathing
  • drowsiness
  • dry mouth
  • fast heartbeat
  • hyperventilation
  • irregular heartbeats
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lightheadedness, dizziness, or fainting
  • nausea
  • nervousness
  • noisy breathing
  • pale or blue lips, fingernails, or skin
  • restlessness
  • shaking
  • shortness of breath
  • slow or irregular heartbeat
  • tightness in the chest
  • trouble sleeping
  • unable to speak
  • unusual tiredness
  • weakness
  • wheezing
Rare
  • Attack, assault, or force
  • changes in patterns and rhythms of speech
  • feeling of constant movement of self or surroundings
  • headache
  • lack or loss of self-control
  • loss of balance
  • mood swings
  • noisy breathing
  • not breathing
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shakiness and unsteady walk
  • sleepiness
  • slow to respond
  • slurred speech
  • trouble in speaking
  • unconsciousness
  • unsteadiness, trembling, or other problems with muscle control or coordination

If any of the following symptoms of overdose occur while taking midazolam, get emergency help immediately:

Symptoms of overdose:
  • Change in consciousness
  • difficulty with coordination
  • loss of consciousness
  • sleepiness or unusual drowsiness

Minor Side Effects

Some midazolam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Vomiting
Less common:
  • Rash
Rare
  • Blurred vision
  • double vision
  • gagging
  • hiccups
  • seeing double
  • watering of mouth and drooling

For Healthcare Professionals

Applies to midazolam: compounding powder, injectable solution, intravenous solution, oral syrup

General

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]

References

1. "Product Information. Versed (midazolam)." Roche Laboratories, Nutley, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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

It is possible that some side effects of Versed may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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