Nayzilam Side Effects
Generic name: midazolam
Note: This document provides detailed information about Nayzilam Side Effects associated with midazolam. Some dosage forms listed on this page may not apply specifically to the brand name Nayzilam.
Applies to midazolam: injection solution.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
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 Nayzilam
Along with its needed effects, midazolam (the active ingredient contained in Nayzilam) 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 side effects
- 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 Nayzilam
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 side effects
- 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 side effects
- muscle stiffness
Precautions
It is very important that your doctor check your progress closely after you receive this medicine to make sure it is working properly and to check for any unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.
Symptoms of an overdose include: change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular, fast or slow, or shallow breathing, lack of coordination, loss of strength or energy, muscle pain or weakness, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.
This medicine may cause respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines. Tell your doctor if you are using any narcotic medicine, such as droperidol, fentanyl, meperidine, morphine, or secobarbital.
This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Talk this with your doctor if you are concerned.
This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates (used for seizures), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you Stop taking midazolam. Check with your doctor before using any of the above while you are receiving this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
For healthcare professionals
Applies to midazolam: compounding powder, injectable solution, intramuscular solution, intravenous solution, nasal spray, oral syrup.
General adverse events
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]
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References
1. (2001) "Product Information. Versed (midazolam)." Roche Laboratories
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Nayzilam side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.