Nayzilam Side Effects

Generic name: midazolam

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 6, 2025.

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: nasal spray.

Other dosage forms:

• injection solution
• oral syrup

Common 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:

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 immediately if any of the following side effects occur while taking midazolam:

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
• drowsiness
• lack of coordination
• loss of consciousness
• loss of strength or energy
• nightmares
• relaxed and calm feeling
• shakiness and unsteady walk
• sleepiness
• slurred speech
• talkativeness
• trouble speaking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual excitement, nervousness, restlessness, or irritability
• unusual weak feeling

Precautions

It is very important that your doctor check your or your child's progress while you are using this medicine to make sure that this medicine is working properly and to check for 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.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms including changes in behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, trouble concentrating, seeing or hearing things that others do not see or hear, thoughts of killing oneself, trouble sleeping, unusual movements, responses, or expressions.

Symptoms of an overdose include: changes in patterns and rhythms of speech, confusion, drowsiness, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, muscle pain or weakness, nightmares, relaxed and calm feeling, sleepiness or unusual drowsiness, shakiness and unsteady walk, slurred speech, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, 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 codeine, fentanyl, hydrocodone, morphine, or oxymorphone.

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, other prescription pain medicine or narcotics, barbiturates or seizure medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

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. Get up slowly or lie down for a while to relieve dizziness or lightheadedness.

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).

Call your doctor right away:

• If your seizures still continue after using this medicine.
• If your seizures are different from your previous episodes.
• If you are alarmed by the number or severity of your seizure episodes.
• If you are alarmed by the color or breathing of the patient.

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]

See also:

Frequently asked questions

• What is the correct way to use Nayzilam Nasal Spray?
• Nayzilam vs Valtoco: How do they compare?

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.

Medical Disclaimer