Flumazenil
Antidotes
- Drug class
- Antidotes
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 8
- FDA reports (12 mo)
- 53
Overview
Plain-language summary, compiled from the cited regulatory records
Flumazenil is a medication classified as an antidote [1]. It is approved for the complete or partial reversal of sedative effects caused by benzodiazepines [1]. This includes situations where benzodiazepines were used to induce or maintain general anesthesia, produce sedation for diagnostic and therapeutic procedures, or in cases of benzodiazepine overdose [1]. Flumazenil is also indicated for the reversal of conscious sedation in pediatric patients aged 1 to 17 years [1].
In the past 12 months, there have been 53 adverse event reports associated with flumazenil [2]. Some of the top reported adverse events include drug ineffectiveness, somnolence, delirium, epilepsy, and falls [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | April 17, 2026 |
| CA Canada | Health Canada | 3 | March 10, 2026 |
| US United States | FDA | 1 | February 14, 2025 |
GBUnited Kingdom· MHRA
4 products
Uses
Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations: In anaesthesia - Termination of hypnosedative effects in general anaesthesia induced and/or maintained with benzodiazepines in hospitalized patients.
- Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic procedures in ambulatory patients and hospitalized patients. - Reversal of paradoxical reactions due to benzodiazepines. - For the reversal of conscious sedation induced with benzodiazepines in children >1 year of age.
In intensive care situations - For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration. - For treatment of intoxications or overdose with only or mainly benzodiazepines. - As a diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other medicines or drugs or brain damage.
CACanada· Health Canada
3 products
How to take
FLUMAZENIL INJECTION SHOULD BE ADMINISTERED INTRAVENOUSLY BY A PHYSICIAN WITH EXPERIENCE IN ANESTHESIOLOGY. Flumazenil Injection is not indicated for epileptic patients who have been treated with benzodiazepines for a prolonged period.
The abrupt cessation of the protective effect of benzodiazepines may induce convulsions in epileptic patients. Caution should be exercised with initial and repeated dosing to patients with hepatic insufficiency as elimination of flumazenil can be delayed in these patients (see ACTION AND CLINICAL PHARMACOLOGY-Hepatic Impairment).
The dose of Flumazenil Injection should always be individually titrated to the desired response to avoid abrupt awakening. Particular care is needed with patients who are physically dependent on benzodiazepines, patients who have ingested multiple drugs, and patients who are prone to anxiety.
In the intensive care unit, in patients treated with high doses of benzodiazepines and/or for long periods of time, the individually titrated injections of Flumazenil Injection, slowly administered, should not produce withdrawal syndromes (see PRECAUTIONS).
USUnited States· FDA
1 product
Uses
INDICATIONS AND USAGE
Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17) Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).
How to take
Drug interactions
Known interactions involving Flumazenil. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL154130037 · revised April 17, 2026
- [2]Health Canada (DPD) · 02249561 · revised March 22, 2025
- [3]FDA DailyMed · 1855bb03-392f-4a… · revised February 14, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.