Summary
Commonly reported side effects of midazolam include: apnea and bradypnea. Other side effects include: variable blood pressure. Continue reading for a comprehensive list of adverse effects.
Applies to midazolam: injection solution. Other dosage forms:
- nasal spray
- oral syrup
Warning
Injection route (Solution)
Midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Use only in settings that can provide for continuous monitoring of respiratory and cardiac function. The initial dose and all subsequent doses should always be titrated slowly. Midazolam injection should not be administered by rapid injection in the neonatal population as severe hypotension and seizures have been reported.
Serious side effects of Midazolam
Along with its needed effects, midazolam 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 midazolam:
Less common
- Aggressiveness
- agitation
- anxiety
- choking
- confusion
- decreased awareness or responsiveness
- decreased urine output
- difficulty walking, speaking, or writing
- discouragement
- dizziness
- feeling sad or empty
- fever
- headache
- irritability
- lack of appetite
- loss of bladder or bowel control
- loss of consciousness
- loss of interest or pleasure
- memory loss
- muscle twitching
- nausea
- nightmares or unusually vivid dreams
- rapid weight gain
- seizures
- severe sleepiness
- strong urge to urinate
- swelling of the face, ankles, or hands
- thirst
- trouble concentrating
- trouble sleeping
- trouble breathing
- unable to speak
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Get emergency help immediately if any of the following symptoms of overdose occur while taking midazolam:
Symptoms of overdose
- Agitation
- changes in patterns and rhythms of speech
- confusion
- excitement
- irritability
- lack of coordination
- loss of strength or energy
- muscle pain or weakness
- relaxed and calm feeling
- restlessness
- shakiness and unsteady walk
- slurred speech
- talkativeness
- trouble in speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual weak feeling
Other side effects of Midazolam
Some side effects of midazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Rare
- Muscle stiffness
For Healthcare Professionals
Applies to midazolam: compounding powder, injectable solution, intramuscular solution, intravenous solution, nasal spray, 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]