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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

Boxed warning

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 usage

Methohexital 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June 27, 1960 Brevital Sodium, Ph Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usage

Methohexital 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.

StartedClassCompanyReason
June 24, 2026Class IIQuVa Pharma, Inc. not a listed makerFailed Impurities/Degradation Specifications
June 7, 2026Class IIONESOURCE SPECIALTY PHARMA LIMITEDFailed Impurities/Degradation Specifications
April 20, 2016Class IIPharmakon Pharmaceuticals, Inc. not a listed makerLack 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 namedSectionWhat the label says
Ethyl alcoholwarningsThe CNS-depressant effect of Methohexital Sodium for Injection may be additive with that of other CNS depressants, including ethyl alcohol and propylene glycol.
HeparinwarningsArterial injection of heparin at the site of injury, followed by systemic anticoagulation.
Phenytoindrug interactionsDrug Interactions Prior chronic administration of barbiturates or phenytoin (e.g. for seizure disorder) appears to reduce the effectiveness of BREVITAL.

Check methohexital against other medicines

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

  • Drug Ineffective (a use or a product term, not a reaction)63
  • Product Quality Issue (a use or a product term, not a reaction)25
  • Off Label Use (a use or a product term, not a reaction)8
  • Drug Effect Decreased7
  • Vomiting (named in the label)7
  • Nausea (named in the label)6
  • Drug Effect Less Than Expected5
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)5

Side effects: the label's list and every FAERS reaction

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