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Midazolam Side Effects

In Summary

Commonly reported side effects of midazolam include: apnea and bradypnea. Other side effects include: variable blood pressure. See below for a comprehensive list of adverse effects.

For the Consumer

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

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by midazolam. In the event that any of these side effects do occur, they may 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 of the side effects that can occur with midazolam may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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, 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, adverse behavior

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

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

Parenteral:
Frequency not reported: Hypersensitivity, anaphylactic shock
Postmarketing reports: Allergic reaction, anaphylactoid reactions[Ref]

Musculoskeletal

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

Not all side effects for midazolam may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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