What the label lists and what reports show
Remimazolam side effects
Remimazolam's FDA label: “The most common adverse reactions (>10%) in patients receiving BYFAVO for procedural sedation are hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.” FAERS holds 106 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 anaphylactic shock (28 reports).
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the remimazolam FDA label on DailyMed (effective February 20, 2025, Acacia Pharma, Ltd.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>10%) in patients receiving BYFAVO for procedural sedation are hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.
Table 3: Common Adverse Reactions in Colonoscopy Study 2 (Incidence >2%), ASA III and IV
| Adverse Reaction | BYFAVO N = 31 n (%) | Placebo (with Midazolam Rescue 16/16 (100%) patients received midazolam rescue. ) N = 16 n (%) | Midazolam N = 30 n (%) |
|---|---|---|---|
| Hypotension Hypotension defined as a fall in systolic BP to ≤80 mmHg or in diastolic BP… | 18 (58%) | 11 (69%) | 17 (57%) |
| Hypertension Hypertension defined as an increase in systolic BP to ≥180 mmHg or in… | 13 (42%) | 6 (38%) | 13 (43%) |
| Respiratory acidosis | 6 (19%) | 2 (13%) | 8 (27%) |
| Diastolic hypertension | 3 (10%) | 0 (0%) | 0 (0%) |
| Systolic hypertension | 2 (6%) | 0 (0%) | 0 (0%) |
| Bradycardia | 1 (3%) | 1 (6%) | 4 (13%) |
| Respiratory rate decreased | 1 (3%) | 1 (6%) | 2 (7%) |
| Diastolic hypotension | 1 (3%) | 1 (6%) | 0 (0%) |
| Blood pressure diastolic increased | 1 (3%) | 0 (0%) | 0 (0%) |
| Blood pressure increased | 1 (3%) | 0 (0%) | 0 (0%) |
| Blood pressure systolic increased | 1 (3%) | 0 (0%) | 0 (0%) |
| Upper respiratory tract infection | 1 (3%) | 0 (0%) | 0 (0%) |
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.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections: Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.4), Use in Specific Populations (8.1) ] The most common adverse reactions (>10%) in patients receiving BYFAVO for procedural sedation are hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BYFAVO was evaluated in three prospective, randomized, double-blind, multicenter, parallel group clinical studies in 630 patients undergoing colonoscopy (two studies) or bronchoscopy (one study). Colonoscopy Study 1 and the bronchoscopy study evaluated American Society of Anesthesiologists (ASA) physical status I to III patients, and Colonoscopy Study 2 evaluated ASA III and IV patients. All three studies evaluated the safety of BYFAVO compared to placebo with midazolam rescue and an open-label midazolam treatment arm. …
Source: FDA drug label, Acacia Pharma, Ltd., effective February 20, 2025 (SPL set 4e1838f2-b999-41a7-a761-d94f09aa531f), via openFDA; the full label on DailyMed
What do FAERS reports show?
106 reports list remimazolam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 12 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 22 reactions below, 5 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.
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?
- Remimazolam: 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