Prescription medicine
Methohexital Brand names: Brevital; first approved as Brevital Sodium
Methohexital (Brevital) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the methohexital FDA label on DailyMed (effective January 28, 2026, ONESOURCE SPECIALTY PHARMA LIMITED); the NDA 11559 record on Drugs@FDA; every methohexital label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Methohexital Sodium for Injection should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient. (See WARNINGS.)
Used for
From the label: indications and usageMethohexital Sodium for Injection can be used in adults as follows: 1.For intravenous induction of anesthesia prior to the use of other general anesthetic agents.
Forms and strengths
- 500 mg
Injection; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- June 27, 1960 Brevital Sodium, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first October 3, 2024; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest June 7, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 122 through July 30, 2026
What is methohexital used for?
From the label: indications and usageMethohexital Sodium for Injection can be used in adults as follows: 1.For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2.For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; […]
FDA pharmacologic class: Barbiturate.
Source: FDA drug label (Methohexital Sodium), ONESOURCE SPECIALTY PHARMA LIMITED, effective January 28, 2026 (SPL set 6fb09acf-4937-47a0-a9da-084ec062da6f), via openFDA; the full label on DailyMed
Is there a generic for methohexital (Brevital)?
The FDA approved the first generic methohexital on October 3, 2024. 1 generic application is approved; 1 of it carries 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 methohexital from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1960 earliest approval on file
- 2024 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has methohexital been recalled?
The FDA's Enforcement Report lists 3 recalls naming methohexital since 2016: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of methohexital and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 24, 2026 | Class II | QuVa Pharma, Inc. not a listed maker | Failed Impurities/Degradation Specifications |
| June 7, 2026 | Class II | ONESOURCE SPECIALTY PHARMA LIMITED | Failed Impurities/Degradation Specifications |
| April 20, 2016 | Class II | Pharmakon Pharmaceuticals, Inc. not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the methohexital label say about other medicines?
The methohexital label names 3 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Ethyl alcohol | warnings | The CNS-depressant effect of Methohexital Sodium for Injection may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol. |
| Heparin | warnings | Arterial injection of heparin at the site of injury, followed by systemic anticoagulation. |
| Phenytoin | drug interactions | Drug Interactions Prior chronic administration of barbiturates or phenytoin (e.g. for seizure disorder) appears to reduce the effectiveness of BREVITAL. |
Source: FDA drug label (Methohexital Sodium), ONESOURCE SPECIALTY PHARMA LIMITED, effective January 28, 2026 (SPL set 6fb09acf-4937-47a0-a9da-084ec062da6f), via openFDA; the full label on DailyMed
What do FAERS reports show for methohexital?
The FDA Adverse Event Reporting System holds 122 reports that list methohexital among the medicines taken, through July 30, 2026, 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other barbiturates
- the pharmacologic class, with prices and generics
- Methohexital side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other