Prescription medicine
Flumazenil First approved as Romazicon
Flumazenil (Romazicon) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $1.18 per mL (Flumazenil 0.5 mg/5 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the flumazenil FDA label on DailyMed (effective June 21, 2024, Hikma Pharmaceuticals USA Inc.); the NDA 20073 record on Drugs@FDA; every flumazenil label on DailyMed.
Highlights of the record
FDA label of June 21, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
THE USE OF FLUMAZENIL HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF SEIZURES. THESE ARE MOST FREQUENT IN PATIENTS WHO HAVE BEEN ON BENZODIAZEPINES FOR LONG-TERM SEDATION OR IN OVERDOSE CASES WHERE PATIENTS ARE SHOWING SIGNS OF SERIOUS CYCLIC ANTIDEPRESSANT OVERDOSE. PRACTITIONERS SHOULD INDIVIDUALIZE THE DOSAGE OF FLUMAZENIL AND BE PREPARED TO MANAGE SEIZURES.
Used for
From the label: indications and usageAdult 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.
Forms and strengths
- 0.1 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- December 20, 1991 Romazicon, Hoffmann La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first October 12, 2004; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.18 per mL Flumazenil 0.5 mg/5 mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 849 through July 30, 2026
What is flumazenil used for?
From the label: indications and usageAdult 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).
FDA pharmacologic class: Benzodiazepine Antagonist.
Source: FDA drug label (Flumazenil), Hikma Pharmaceuticals USA Inc., effective June 21, 2024 (SPL set 436f5616-9626-4b6a-9deb-2986444179d0), via openFDA; the full label on DailyMed
Is there a generic for flumazenil (Romazicon)?
The FDA approved the first generic flumazenil on October 12, 2004. 9 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists flumazenil from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2004 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for flumazenil (Romazicon)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.18 per mL (Flumazenil 0.5 mg/5 mL vial), up 15% from $1.03 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Flumazenil 0.5 mg/5 mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Flumazenil 0.5 mg/5 mL vial | Generic | $1.18 per mL | $5.90 per vial | +15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the flumazenil label say about other medicines?
The flumazenil label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 17 other medicines name flumazenil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | warnings | Most convulsions associated with flumazenil administration require treatment and have been successfully managed with benzodiazepines, phenytoin or barbiturates. |
Other labels that name flumazenil
Source: FDA drug label (Flumazenil), Hikma Pharmaceuticals USA Inc., effective June 21, 2024 (SPL set 436f5616-9626-4b6a-9deb-2986444179d0), via openFDA; the full label on DailyMed
What do FAERS reports show for flumazenil?
The FDA Adverse Event Reporting System holds 849 reports that list flumazenil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 170 are coded as a death and 479 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Flumazenil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other