Prescription medicine
Sevoflurane Brand names: Ultane, Sojourn
Sevoflurane (Sojourn) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
Check it at the source: the sevoflurane FDA label on DailyMed (effective February 12, 2025, AbbVie Inc.); the NDA 20478 record on Drugs@FDA; every sevoflurane label on DailyMed.
Highlights of the record
FDA label of February 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
Forms and strengths
- 1 ml/ml
- 250 ml/250ml
Liquid.
On the market
- Earliest approval on file
- June 7, 1995 Ultane, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first July 2, 2002; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 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)
- 3 since 2014 0 Class I among all firms' recalls; latest June 13, 2019
- FAERS reports
- 8,262 through July 30, 2026
What is sevoflurane used for?
From the label: indications and usageULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
FDA pharmacologic class: General Anesthetic.
Source: FDA drug label (Ultane), AbbVie Inc., effective February 12, 2025 (SPL set c9aa6489-5a36-44ed-9512-b996833d82f7), via openFDA; the full label on DailyMed
Is there a generic for sevoflurane (Sojourn)?
The FDA approved the first generic sevoflurane on July 2, 2002. 5 generic applications are approved; 5 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 sevoflurane from 9 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.
- 1995 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sevoflurane been recalled?
The FDA's Enforcement Report lists 3 recalls naming sevoflurane since 2014: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 13, 2019 | Class II | Baxter Healthcare Corporation | Failed Stability Specifications |
| January 22, 2018 | Class III | AbbVie Inc. | Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage. |
| April 7, 2014 | Class II | Piramal Critical Care, Inc. | Failed pH Specifications: product was too acidic. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sevoflurane label say about other medicines?
The sevoflurane label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name sevoflurane. 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 |
|---|---|---|
| Atracurium | drug interactions | When used to supplement alfentanil-N 2 O anesthesia, sevoflurane and isoflurane equally potentiate neuromuscular block induced with pancuronium, vecuronium or atracurium. |
| Dantrolene | warnings | If malignant hyperthermia is suspected, discontinue all triggering agents (i.e., volatile anesthetic agents and succinylcholine), administer intravenous dantrolene sodium, and initiate supportive therapies. |
| Epinephrine | drug interactions | Epinephrine Epinephrine administered with sevoflurane may increase the risk of ventricular arrhythmias. |
| Isoflurane | drug interactions | When used to supplement alfentanil-N 2 O anesthesia, sevoflurane and isoflurane equally potentiate neuromuscular block induced with pancuronium, vecuronium or atracurium. |
| Nitrous oxide | drug interactions | Nitrous Oxide As with other halogenated volatile anesthetics, the anesthetic requirement for sevoflurane is decreased when administered in combination with nitrous oxide. |
| Propofol | drug interactions | Intravenous Anesthetics Sevoflurane administration is compatible with barbiturates, propofol, and other commonly used intravenous anesthetics. |
| Succinylcholine | drug interactions | The effect of sevoflurane on the duration of depolarizing neuromuscular blockade induced by succinylcholine has not been studied. |
| Vecuronium | drug interactions | When used to supplement alfentanil-N 2 O anesthesia, sevoflurane and isoflurane equally potentiate neuromuscular block induced with pancuronium, vecuronium or atracurium. |
| Verapamil | drug interactions | In animals, impairment of atrioventricular conduction has been observed when verapamil and sevoflurane are administered concomitantly. |
Other labels that name sevoflurane
Source: FDA drug label (Ultane), AbbVie Inc., effective February 12, 2025 (SPL set c9aa6489-5a36-44ed-9512-b996833d82f7), via openFDA; the full label on DailyMed
What do FAERS reports show for sevoflurane?
The FDA Adverse Event Reporting System holds 8,262 reports that list sevoflurane among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 557 are coded as a death and 2,863 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?
- Other general anesthetics
- the pharmacologic class, with prices and generics
- Sevoflurane side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other