ADVERSE REACTIONS
See WARNINGS concerning serious cardiorespiratory events and possible paradoxical reactions. Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults and included decreased tidal volume and/or respiratory rate decrease (23.3% of patients following IV and 10.8% of patients following IM administration) and apnea (15.4% of patients following IV administration), as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam is administered with other medications capable of depressing the central nervous system. The incidence of such events is higher in patients undergoing procedures involving the airway without the protective effect of an endotracheal tube, e.g., upper endoscopy and dental procedures.
Adults
The following additional adverse reactions were reported after intramuscular administration:
headache (1.3%) |
Local effects at IM Injection site
|
| pain (3.7%) |
| induration (0.5%) |
| redness (0.5%) |
| muscle stiffness (0.3%) |
Administration of IM midazolam to elderly and/or higher risk surgical patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression. In most of these cases, the patients also received other central nervous system depressants capable of depressing respiration, especially narcotics (see DOSAGE AND ADMINISTRATION).
The following additional adverse reactions were reported subsequent to intravenous administration as a single sedative/anxiolytic/ amnestic agent in adult patients:
hiccoughs (3.9%) |
Local effects at the IV site
|
nausea (2.8%) |
tenderness (5.6%) |
vomiting (2.6%) |
pain during injection (5.0%) |
coughing (1.3%) |
redness (2.6%) |
“oversedation” (1.6%) |
induration (1.7%) |
headache (1.5%) |
phlebitis (0.4%) |
drowsiness (1.2%) |
|
Pediatric Patients
The following adverse events related to the use of IV midazolam in pediatric patients were reported in the medical literature: desaturation 4.6%, apnea 2.8%, hypotension 2.7%, paradoxical reactions 2.0%, hiccough 1.2%, seizure-like activity 1.1% and nystagmus 1.1%. The majority of airway-related events occurred in patients receiving other CNS depressing medications and in patients where midazolam was not used as a single sedating agent.
Neonates
For information concerning hypotensive episodes and seizures following the administration of midazolam to neonates, see BOX WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections.
Other adverse experiences, observed mainly following IV injection as a single sedative/anxiolytic/amnesia agent and occurring at an incidence of <1.0% in adult and pediatric patients, are as follows:
Respiratory
Laryngospasm, bronchospasm, dyspnea, hyperventilation, wheezing, shallow respirations, airway obstruction, tachypnea.
Cardiovascular
Bigeminy, premature ventricular contractions, vasovagal episode, bradycardia, tachycardia, nodal rhythm.
Gastrointestinal
Acid taste, excessive salivation, retching.
CNS/Neuromuscular
Retrograde amnesia, euphoria, hallucination, confusion, argumentativeness, nervousness, anxiety, grogginess, restlessness, emergence delirium or agitation, prolonged emergence from anesthesia, dreaming during emergence, sleep disturbance, insomnia, nightmares, athetoid movements, seizure-like activity, ataxia, dizziness, dysphoria, slurred speech, dysphonia, paresthesia.
Special Sense
Blurred vision, diplopia, nystagmus, pinpoint pupils, cyclic movements of eyelids, visual disturbance, difficulty focusing eyes, ears blocked, loss of balance, light-headedness.
Integumentary
Hive-like elevation at injection site, swelling or feeling of burning, warmth or coldness at injection site.
Hypersensitivity
Allergic reactions including anaphylactoid reactions, hives, rash, pruritus.
Miscellaneous
Yawning, lethargy, chills, weakness, toothache, faint feeling, hematoma.
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