What the label lists and what reports show
Midazolam side effects
Midazolam's FDA label lists its adverse reactions in its own words. FAERS holds 29,268 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is seizure (1,697 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsSee 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. …
Table 2: Adverse Reactions Adverse reactions that occurred within 2 days after NAYZILAM administration are included that Occurred in ≥2% of Patients (Any NAYZILAM) and Greater than Placebo in the Comparative Phase of…
This table is printed in the Nayzilam label published by UCB, Inc. of January 19, 2023; the label quoted above does not print one.
| Reaction | N = 26 % | N = 91 % | N = 41 % | N = 43 % | N = 175 % |
|---|---|---|---|---|---|
| Somnolence | 4 | 10 | 10 | 9 | 10 |
| Headache | 0 | 7 | 0 | 2 | 4 |
| Dysarthria | 0 | 2 | 2 | 2 | 2 |
| Nasal Discomfort | 8 | 5 | 7 | 16 | 9 |
| Throat Irritation | 0 | 2 | 2 | 7 | 3 |
| Rhinorrhea | 0 | 3 | 0 | 5 | 3 |
| Product Taste Abnormal | 0 | 4 | 0 | 0 | 2 |
| Lacrimation Increased | 0 | 1 | 2 | 2 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,268 reports list midazolam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,581 are coded as a death and 13,549 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Midazolam: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions