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Remimazolam Side Effects

The most commonly reported side effects of remimazolam include anaphylactic shock, cardiac arrest, and electrocardiogram qt prolonged, based on 177 FDA adverse event reports from 2005 to 2025. 4.0% of reports found the drug to be ineffective.

Remimazolam side effects

Percentages show how often each reaction appears relative to total reports for remimazolam.

1
Anaphylactic Shock11.3%20
2
Cardiac Arrest7.3%13
3
Electrocardiogram Qt Prolonged6.8%12
4
Local Anaesthetic Systemic Toxicity6.8%12
5
Vascular Access Site Occlusion6.2%11
6
Anaphylactic Reaction6.2%11
7
Hypotension5.6%10
8
Oxygen Saturation Decreased5.6%10
9
Off Label Use5.1%9
10
Blood Pressure Decreased5.1%9
11
Electrocardiogram Qrs Complex Prolonged5.1%9
12
Drug Ineffective4.0%7
13
Hypoxia3.4%6
14
Erythema3.4%6
15
Bronchospasm3.4%6

These are voluntary reports and do not establish that remimazolam caused these reactions.

Report severity

92.1%Serious163 reports
25.4%Hospitalizations45 reports
2.8%Fatal5 reports

Seriousness is determined by the reporter, not by OpenClaim.

Remimazolam drug interactions

Other drugs that appear in adverse event reports alongside remimazolam. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Remifentanil-hydrochloride23.2%41
2
Rocuronium-bromide16.9%30
3
Fentanyl13.0%23
4
Lidocaine10.2%18
5
Propofol9.6%17
6
Sufentanil-citrate6.2%11
7
Cisatracurium-besylate5.1%9
8
Dexmedetomidine-hydrochloride3.4%6
9
Epinephrine3.4%6
10
Macitentan2.8%5
11
Cyclophosphamide2.3%4
12
Dexamethasone2.3%4
13
Desflurane1.7%3
14
Etomidate1.7%3
15
Bortezomib1.7%3

Taken alongside

1
Remifentanil-hydrochloride22.0%39
2
Fentanyl19.2%34
3
Rocuronium-bromide16.9%30
4
Sodium-chloride9.6%17
5
Propofol7.3%13
6
Epinephrine5.1%9
7
Flumazenil4.5%8
8
Oxygen4.0%7
9
Vasopressin4.0%7
10
Acetaminophen3.4%6
11
Dobutamine-hydrochloride3.4%6
12
Pantoprazole-sodium2.8%5
13
Lidocaine2.8%5
14
Sodium-picosulfate2.8%5
15
Dexamethasone2.3%4

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports remimazolam side effects

31.6% of remimazolam adverse event reports involve female patients and 49.7% involve male patients. The largest age group is adult at 48%. These figures reflect who reports side effects, not underlying risk.

Sex

Female31.6%
Male49.7%
Unknown18.6%

Age group

< 22.8%
2–111.4%
12–171.4%
18–6448.3%
65+46.2%

What is remimazolam used for

Conditions and purposes for which patients were taking remimazolam when the adverse event was reported.

AnaesthesiaAnaesthesiaAnaesthesia ProcedureAnxietyGeneral AnaesthesiaGeneral AnaesthesiaInduction And Maintenance Of AnaesthesiaInduction Of AnaesthesiaLocal AnaesthesiaMaintenance Of AnaesthesiaMaintenance Of AnaesthesiaNeuromuscular BlockadeOesophagogastroscopyProduct Used For Unknown IndicationProduct Used For Unknown Indication

Showing 15 of 20 indications

Remimazolam brand names and reporting trend

Remimazolam is sold under the brand name Byfavo.

Brand names

Byfavo147

Quarterly reports (20052025)

20052025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking remimazolam with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.