Midazolam Side Effects
Please note - some side effects for Midazolam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Midazolam - for the consumer
Midazolam
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Midazolam:
Seek medical attention right away if any of these SEVERE side effects occur when using Midazolam:Blurred vision; changes in blood pressure, breathing, and heartbeats; coughing; dizziness; drowsiness; dry mouth; headache; hiccups; low blood pressure (children); nausea; pain during injection; pain, redness, or tenderness at the injection site; short-term memory loss; slurred speech; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; combativeness; irregular breathing patterns; pain, swelling, or redness at the injection site; slow or difficult breathing; unusual or involuntary muscle movements or muscle tremor.
Midazolam Syrup
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Midazolam Syrup:
Seek medical attention right away if any of these SEVERE side effects occur when using Midazolam Syrup:Dizziness; drowsiness; nausea; short-term memory loss; vomiting.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; combativeness; hyperactivity; irregular breathing patterns; prolonged drowsiness; skipped heartbeats; slow or fast heartbeat; slow or difficult breathing; seizure; severe dizziness; unusual or involuntary muscle movements or muscle tremor.
For the professional
Midazolam
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 hydrochloride 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 hydrochloride 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%) |
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induration (0.5%) |
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redness (0.5%) |
|
muscle stiffness (0.3%) |
Administration of IM Midazolam hydrochloride 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.
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 hydrochloride 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 hydrochloride was not used as a single sedating agent.
Neonates: For information concerning hypotensive episodes and seizures following the administration of Midazolam hydrochloride to neonates,.
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 Senses: 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
TopMidazolam Injection
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 HCl 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 HCl 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 (eg, 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 HCl 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.
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 HCl 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 HCl was not used as a single sedating agent.
Neonates
For information concerning hypotensive episodes and seizures following the administration of Midazolam HCl to neonates, see Boxed WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.
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 Senses
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.
TopMidazolam Injection Hospira
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 hydrochloride 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 hydrochloride 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.
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 hydrochloride 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 hydrochloride to neonates, see Boxed 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 Senses: 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
TopMidazolam Syrup
The distribution of adverse events occurring in patients evaluated in a randomized, double-blind, parallel-group trial are presented in Tables 5 and 6 by body system in order of decreasing frequency: for the premedication period (eg, sedation period prior to induction of anesthesia) alone, see Table 5; for over the entire monitoring period including premedication, anesthesia and recovery, see Table 6.
The distribution of adverse events occurring during the premedication period, before induction of anesthesia, is presented in Table 5. Emesis which occurred in 31/397 (8%) patients over the entire monitoring period, occurred in 3/397 (0.8%) of patients during the premedication period (from Midazolam administration to mask induction). Nausea, which occurred in 14/397 (4%) patients over the entire monitoring period (premedication, anesthesia and recovery), occurred in 2/397 (0.5%) patients during the premedication period.
This distribution of all adverse events occurring in ≥1% of patients over the entire monitoring period are presented in Table 6. For the entire monitoring period (premedication, anesthesia and recovery), adverse events were reported by 82/397 (21%) patients who received Midazolam overall. The most frequently reported adverse events were emesis occurring in 31/397 (8%) patients and nausea occurring in 14/397 (4%) patients. Most of these gastrointestinal events occurred after the administration of other anesthetic agents.
For the respiratory system overall, adverse events (hypoxia, laryngospasm, rhonchi, coughing, respiratory depression, airway obstruction, upper-airway congestion, shallow respirations), occurred during the entire monitoring period in 31/397 (8%) patients and increased in frequency as dosage was increased: 7/132 (5%) patients in the 0.25 mg/kg dose group, 9/132 (7%) patients in the 0.5 mg/kg dose group, and 15/133 (11%) patients in the 1 mg/kg dose group.
Most of the respiratory adverse events occurred during induction, general anesthesia or recovery. One patient (0.25%) experienced a respiratory system adverse event (laryngospasm) during the premedication period. This adverse event occurred precisely at the time of induction. Although many of the respiratory complications occurred in settings of upper airway procedures or concurrently administered opioids, a number of these events occurred outside of these settings as well. In this study, administration of Midazolam HCl syrup was generally accompanied by a slight decrease in both systolic and diastolic blood pressures, as well as a slight increase in heart rate.
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Body System No. Patients with Adverse Events |
Treatment Regimen | Overall | ||
|---|---|---|---|---|
| 0.25 mg/kg (n=132) No. (%) |
0.5 mg/kg (n=132) No. (%) |
1 mg/kg (n=133) No. (%) |
(n=397) No. (%) |
|
| ||||
| Gastrointestinal Sytem Disorders | ||||
| Emesis | 1 (0.76%) | 1 (0.76%) | 1 (0.75%) | 3 (0.76%) |
| Nausea | 2 (1.5%) | 2 (0.50%) | ||
| Respiratory System Disorders | ||||
| Laryngospasm | 1*(0.75%) | 1 (0.25%) | ||
| Sneezing/Rhinorrhea | 1 (0.75%) | 1 (0.25%) | ||
| ALL BODY SYSTEMS | 1 (0.76%) | 1 (0.76%) | 5 (3.8%) | 7 (1.8%) |
| Body System | Treatment Regimen | Overall | ||||||
|---|---|---|---|---|---|---|---|---|
| No. Patients with Adverse Events | 0.25 mg/kg (n=132) |
0.5 mg/kg (n=132) |
1 mg/kg (n=133) |
(n=397) | ||||
| No. | (%) | No. | (%) | No. | (%) | No. | (%) | |
| Gastrointestinal System Disorders | ||||||||
| Emesis | 11 | (8%) | 5 | (4%) | 15 | (11%) | 31 | (8%) |
| Nausea | 6 | (5%) | 2 | (2%) | 6 | (5%) | 14 | (4%) |
| Overall | 16 | (12%) | 8 | (6%) | 16 | (12%) | 40 | (10%) |
| Respiratory System Disorders | ||||||||
| Hypoxia | 0 | 5 | (4%) | 4 | (3%) | 9 | (2%) | |
| Laryngospasm | 0 | 1 | (<1%) | 5 | (4%) | 6 | (2%) | |
| Respiratory Depression | 2 | (2%) | 1 | (<1%) | 2 | (2%) | 5 | (1%) |
| Rhonchi | 2 | (2%) | 1 | (<1%) | 2 | (2%) | 5 | (1%) |
| Airway Obstruction | 2 | (2%) | 2 | (2%) | 0 | 4 | (1%) | |
| Upper Airway Congestion | 2 | (2%) | 0 | 2 | (2%) | 4 | (1%) | |
| Overall | 7 | (5%) | 9 | (7%) | 15 | (11%) | 31 | (8%) |
| Psychiatric Disorders | ||||||||
| Agitated | 1 | (<1%) | 2 | (2%) | 3 | (2%) | 6 | (2%) |
| Overall | 1 | (<1%) | 3 | (2%) | 4 | (3%) | 8 | (2%) |
| Heart Rate, Rhythm Disorders | ||||||||
| Bradycardia | 1 | (<1%) | 3 | (2%) | 0 | 4 | (1%) | |
| Bigeminy | 2 | (2%) | 0 | 0 | 2 | (<1%) | ||
| Overall | 3 | (2%) | 3 | (2%) | 1 | (<1%) | 7 | (2%) |
| Central & Peripheral Nervous System Disorders | ||||||||
| Prolonged Sedation | 0 | 0 | 2 | (2%) | 2 | (<1%) | ||
| Overall | 2 | (2%) | 0 | 3 | (2%) | 5 | (1%) | |
| Skin and Appendages Disorders | ||||||||
| Rash | 2 | (2%) | 0 | 0 | 2 | (<1%) | ||
| Overall | 2 | (2%) | 2 | (2%) | 0 | 4 | (1%) | |
| ALL BODY SYSTEMS | 26 | (20%) | 23 | (17%) | 33 | (25%) | 82 | (21%) |
There were no deaths during the study and no patient withdrew from the study due to adverse events. Serious adverse events (both respiratory disorders) were experienced postoperatively by two patients: one case of airway obstruction and desaturation (SpO2 of 33%) in a patient given Midazolam HCl syrup 0.25 mg/kg, and one case of upper airway obstruction and respiratory depression following 0.5 mg/kg. Both patients had received intravenous morphine sulfate (1.5 mg total for both patients).
Other adverse events that have been reported in the literature with the oral administration of Midazolam (not necessarily Midazolam syrup), are listed below. The incidence rate for these events was generally <1%.
Respiratory: apnea, hypercarbia, desaturation, stridor.
Cardiovascular: decreased systolic and diastolic blood pressure, increased heart rate.
Gastrointestinal: nausea, vomiting, hiccoughs, gagging, salivation, drooling.
Central Nervous System: dysphoria, disinhibition, excitation, aggression, mood swings, hallucinations, adverse behavior, agitation, dizziness, confusion, ataxia, vertigo, dysarthria.
Special Senses: diplopia, strabismus, loss of balance, blurred vision.
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