Versed Side Effects

Generic Name: midazolam

Note: This page contains side effects data for the generic drug midazolam. It is possible that some of the dosage forms included below may not apply to the brand name Versed.

It is possible that some side effects of Versed may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to midazolam: oral solution, oral syrup, oral tablet

Other dosage forms:

As well as its needed effects, midazolam (the active ingredient contained in Versed) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking midazolam, check with your doctor or nurse immediately:

Less common
  • Anxiety
  • chest pain or discomfort
  • choking
  • confusion
  • difficult or troubled breathing
  • drowsiness
  • dry mouth
  • fast heartbeat
  • hyperventilation
  • irregular heartbeats
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lightheadedness, dizziness, or fainting
  • nausea
  • nervousness
  • noisy breathing
  • pale or blue lips, fingernails, or skin
  • restlessness
  • shaking
  • shortness of breath
  • slow or irregular heartbeat
  • tightness in the chest
  • trouble sleeping
  • unable to speak
  • unusual tiredness
  • weakness
  • wheezing
Rare
  • Attack, assault, or force
  • changes in patterns and rhythms of speech
  • feeling of constant movement of self or surroundings
  • headache
  • lack or loss of self-control
  • loss of balance
  • mood swings
  • noisy breathing
  • not breathing
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shakiness and unsteady walk
  • sleepiness
  • slow to respond
  • slurred speech
  • trouble in speaking
  • unconsciousness
  • unsteadiness, trembling, or other problems with muscle control or coordination

If any of the following symptoms of overdose occur while taking midazolam, get emergency help immediately:

Symptoms of overdose
  • Change in consciousness
  • difficulty with coordination
  • loss of consciousness
  • sleepiness or unusual drowsiness

Some midazolam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Vomiting
Less common
  • Rash
Rare
  • Blurred vision
  • double vision
  • gagging
  • hiccups
  • seeing double
  • watering of mouth and drooling

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.[Ref]

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.[Ref]

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) [Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

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

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.[Ref]

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.[Ref]

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.[Ref]

Immunologic

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

Endocrine

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

References

1. Classen DC, Pestotnik SL, Evans RS, Burke JP "Intensive surveillance of midazolam use in hospitalized patients and the occurrence of cardiorespiratory arrest." Pharmacotherapy 12 (1992): 213-6

2. "Product Information. Versed (midazolam)." Roche Laboratories, Nutley, NJ.

3. Taylor JW, Simon KB "Possible intramuscular midazolam-associated cardiorespiratory arrest and death." DICP 24 (1990): 695-7

4. Iber FL, Livak A, Kruss DM "Apnea and cardiopulmonary arrest during and after endoscopy." J Clin Gastroenterol 14 (1992): 109-13

5. Dixon D "Respiratory depression following midazolam." Anaesthesia 40 (1985): 922

6. Berggren L, Eriksson I, Mollenholt P, Sunzel M "Changes in respiratory pattern after repeated doses of diazepam and midazolam in healthy subjects." Acta Anaesthesiol Scand 31 (1987): 667-72

7. Munoz HR, Dagnino JA, Rufs JA, Bugedo GJ "Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients." Reg Anesth 17 (1992): 139-42

8. Birch B, Miller R "Safety of midazolam." Lancet 2 (1988): 683

9. Birch B, Anson K, Miller R "Midazolam, hypotension and neurological sequelae." Anaesthesia 44 (1989): 259

10. Desborough JP, Hall GM, Hart GR, Burrin JM "Midazolam modifies pancreatic and anterior pituitary hormone secretion during upper abdominal surgery." Br J Anaesth 67 (1991): 390-6

11. Arcos GJ "Midazolam-induced ventricular irritability." Anesthesiology 67 (1987): 612

12. Raza SM, Zsigmond EK, Barabas E "Midazolam causes no adverse hemodynamic effects in cardiac patients." Clin Ther 10 (1987): 40-3

13. Raza SM, Masters RW, Zsigmond EK "Comparison of the hemodynamic effects of midazolam and diazepam in patients with coronary occlusion." Int J Clin Pharmacol Ther Toxicol 27 (1989): 1-6

14. Matson AM, Thurlow AC "Hypotension and neurological sequelae following intramuscular midazolam." Anaesthesia 43 (1988): 896

15. Kundrotas L, Charlesworth E "Localized flare reaction to intravenous drug administration for conscious sedation during endoscopy." Gastrointest Endosc 39 (1993): 109-10

16. Stolarek IH, Ford MJ "Acute dystonia induced by midazolam and abolished by flumazenil." BMJ 300 (1990): 614

17. Playford RJ "Allegation of sexual assault following midazolam sedation in a man." Anaesthesia 47 (1992): 818

18. Arrowsmith JB, Gerstman BB, Fleischer DE, Benjamin SB "Results from the American Society for Gastrointestinal Endoscopy/U.S. Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy." Gastrointest Endosc 37 (1991): 421-7

19. Kain ZN, Hofstadter MB, Mayes LC, Krivutza DM, Alexander G, Wang SM, Reznick JS "Midazolam - Effects on amnesia and anxiety in children." Anesthesiology 93 (2000): 676-84

20. Fiset L, Milgrom P, Beirne OR, Roy-Byrne P "Disinhibition of behaviors with midazolam: report of a case." J Oral Maxillofac Surg 50 (1992): 645-9

21. Lobo BL, Miwa LJ "Midazolam disinhibition reaction." Drug Intell Clin Pharm 22 (1988): 725

22. Roelofse JA, Joubert JJ "Unpleasant sequelae of benzodiazepine sedation." Anaesthesia 45 (1990): 890-1

23. Ducharme MP, Munzenberger P "Severe withdrawal syndrome possibly associated with cessation of a midazolam and fentanyl infusion." Pharmacotherapy 15 (1995): 665-8

24. Hantson P, Clemessy JL, Baud FJ "Withdrawal syndrome following midazolam infusion." Intensive Care Med 21 (1995): 190-1

25. Finley PR, Nolan PE, Jr "Precipitation of benzodiazepine withdrawal following sudden discontinuation of midazolam." DICP 23 (1989): 151-2

26. Yakel DL, Jr Whittaker SE, Elstad MR "Midazolam-induced angioedema and bronchoconstriction." Crit Care Med 20 (1992): 307-8

27. Yates A, Russell D "A reaction to midazolam: a topical solution." Anaesthesia 44 (1989): 449

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