Versed Side Effects

Generic name: midazolam

Note: This document contains side effect information about midazolam. Some of the dosage forms listed on this page may not apply to the brand name Versed.

Some side effects of Versed may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to midazolam: oral syrup

Get emergency medical help if you have any of these signs of an allergic reaction while taking midazolam (the active ingredient contained in Versed) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• cough, wheezing, trouble breathing, weak or shallow breathing;

• slow heart rate;

• seizure (convulsions);

• feeling like you might pass out;

• agitation, hostility; or

• confusion, hallucinations, unusual thoughts or behavior.

Less serious side effects of midazolam may include:

• drowsiness, dizziness;

• blurred vision;

• nausea, vomiting;

• runny nose, sneezing;

• mild rash; or

• amnesia or forgetfulness after your procedure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to midazolam: compounding powder, injectable solution, intravenous solution, oral syrup

Respiratory

Respiratory side effects, which have included cardiorespiratory depression, apnea, and respiratory arrest, are extensions of the drugs pharmacologic activity.

Personnel and equipment necessary for the treatment of respiratory depression and arrest should be immediately available whenever midazolam is administered.

One retrospective study has reported that the frequency of respiratory arrest (in nonventilated patients) is 0.099%. This study reported that respiratory arrest was associated with high doses of midazolam, concurrent administration of opioids, and advanced age.

Another study has reported that midazolam causes a decrease in tidal volume, an increase in breathing frequency and no change in minute ventilation in healthy volunteers. That study, however, did report a significant increase in CO2 retention following midazolam administration.

Cardiovascular

Cardiovascular side effects including alterations in blood pressure, arrhythmias, and ventricular irritability have been reported. Hypotension and decreases in systemic vascular resistance have been reported most frequently; however many investigators have reported minimal cardiovascular effects following administration of midazolam (the active ingredient contained in Versed)

Local

Local side effects at the site of injection (local flare reactions, pain, burning, phlebitis, local irritation and swelling) have been reported in up to 12% of patients. Vascular impairment after inadvertent intra-arterial injection is a theoretic concern.

Although local effects have been reported frequently, many clinicians believe that midazolam is the least likely of the commonly available injectable benzodiazepines to result in local reactions.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and hiccups have each been reported in about 3% of treated patients.

Nervous system

Nervous system side effects have included acute dystonia. One study (n=113) has reported that orally administered midazolam (the active ingredient contained in Versed) produced significant anterograde amnesia when administered as early as ten minutes before a surgical procedure.

Psychiatric

Psychiatric side effects have included a variety of adverse behavioral effects such as disinhibition (especially sexual disinhibition), hostility, rage reactions, restlessness, aggressiveness, and paroxysmal excitement.

Other

Other side effects including cases of benzodiazepine withdrawal symptoms (myalgias, tachycardia, and anxiety) have been reported in patients who have received multiple or continuous doses of midazolam (the active ingredient contained in Versed) In such patients, abrupt discontinuation is not recommended.

Immunologic

Immunologic side effects including pruritus, angioedema, and bronchoconstriction have been reported rarely.

Endocrine

Endocrine side effects have included decreases in the secretion of cortisol and insulin.

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