"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...
- Clinician Information:
Midazolam Injection Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Midazolam HCl Injection is used as a sedative before surgery or other medical procedures. It is a benzodiazepine. This medication is available in generic form. Common side effects include headache, or pain, redness, or stiffness at the injection site.
Dosing of midazolam is individualized. The recommended premedication dose of midazolam for low risk adult patients below the age of 60 years is 0.07 to 0.08 mg/kg IM (approximately 5 mg IM) administered up to 1 hour before surgery. Midazolam may interact with H2 blockers, fluconazole, theophylline, aminophylline, erythromycin, or drugs that make you drowsy, such as: narcotics, psychiatric medicines, anti-anxiety drugs, anti-seizure drugs, antihistamines, muscle relaxants, sleeping pills, or sedatives. Tell your doctor all medications and supplements you use. During pregnancy, midazolam should be used only if prescribed. It may harm a fetus. Infants born to mothers who have used this drug during pregnancy may have withdrawal symptoms. This drug passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Midazolam HCl Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Midazolam Injection FDA Prescribing Information: Side Effects
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 (eg, upper endoscopy and dental procedures).
The following additional adverse reactions were reported after intramuscular administration:
|headache (1.3%)||Local effects at IM Injection site|
| pain (3.7%)
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%)
pain during injection (5.0%)
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.
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:
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.
Drug Abuse And Dependence
Midazolam is subject to Schedule IV control under the Controlled Substances Act of 1970.
Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs.
Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam.
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. There is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient's needs. In some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days.
Read the entire FDA prescribing information for Midazolam Injection (Midazolam) »
Additional Midazolam Injection Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.