Midazolam: Side Effects, Uses & Monitoring
Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.
- Data source
- FDA labeling via NIH DailyMed (label 9a443652…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Overall | 40% |
| Hypoxia | 9% |
| Agitated | 6% |
| Respiratory depression | 5% |
| Rhonchi | 5% |
| Airway obstruction | 4% |
| Upper airway congestion | 4% |
| Bradycardia | 4% |
| Emesis | 3% |
| Nausea | 2% |
| Bigeminy | 2% |
| Prolonged sedation | 2% |
| Rash | 2% |
| Laryngospasm | 1% |
| Sneezing/ rhinorrhea | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS ].
Frequently Asked Questions
What is Midazolam used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Midazolam?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Midazolam. Individual risk varies.
Does Midazolam require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Midazolam.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.