Prescription medicine
Remifentanil Brand names: Ultiva
Remifentanil (Ultiva) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the remifentanil FDA label on DailyMed (effective December 15, 2025, Mylan Institutional LLC); the NDA 20630 record on Drugs@FDA; every remifentanil label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA.
Addiction, Abuse, and Misuse Because the use of ULTIVA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ULTIVA, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ULTIVA are essential [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of ULTIVA and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7) ]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ULTIVA See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageULTIVA is indicated for intravenous (IV) administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
Forms and strengths
- 1 mg/ml
- 2 mg/2ml
- 5 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- July 12, 1996 Ultiva, Mylan Institutional; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first January 16, 2018; 3 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)
- 3 of 9 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 0 since 2015 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 2,362 through July 30, 2026
What is remifentanil used for?
From the label: indications and usageULTIVA is indicated for intravenous (IV) administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
As an analgesic component of monitored anesthesia care in adult patients. ULTIVA is an opioid agonist indicated for intravenous administration:
As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. […]
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Ultiva), Mylan Institutional LLC, effective December 15, 2025 (SPL set 4dbcb8f9-1987-4b66-bd2f-d251fda0be10), via openFDA; the full label on DailyMed
Is there a generic for remifentanil (Ultiva)?
The FDA approved the first generic remifentanil on January 16, 2018. 3 generic applications are approved; 3 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 remifentanil 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.
- 1996 earliest approval on file
- 2018 first generic approved
- 2022 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is remifentanil in shortage?
The FDA Drug Shortage Database lists 3 of 9 remifentanil presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on June 28, 2022. 6 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Remifentanil Hydrochloride, Injection, 1 mg per vial (NDC 0143-9391-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-723-03) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-724-05) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Remifentanil Hydrochloride, Injection, 1 mg/1 mL (NDC 63323-725-10) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Remifentanil Hydrochloride, Injection, 2 mg per vial (NDC 0143-9392-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Remifentanil Hydrochloride, Injection, 5 mg per vial (NDC 0143-9393-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ultiva, Injection, 1 mg/1 mL (NDC 72078-034-01) | Mylan Institutional, a Viatris Company | Current | October 5, 2026 |
| Ultiva, Injection, 2 mg (NDC 72078-035-02) | Mylan Institutional, a Viatris Company | Current | October 5, 2026 |
Every remifentanil presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has remifentanil been recalled?
The FDA's Enforcement Report lists 1 recall naming remifentanil since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of remifentanil and that holds 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 |
|---|---|---|---|
| July 17, 2015 | Class II | Pharmedium Services, LLC not a listed maker | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the remifentanil label say about other medicines?
The remifentanil label names 22 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name remifentanil. 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 |
|---|---|---|
| Atropine | warnings and precautions | Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. |
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of ULTIVA and/or precipitate withdrawal symptoms. … alternative analgesic treatment. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of ULTIVA and/or precipitate withdrawal symptoms. … appropriately to treatment and institute alternative analgesic treatment. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine |
| Cyclobenzaprine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as … |
| Diazepam | warnings and precautions | When high dose or anesthetic dosages of ULTIVA are employed, even relatively small dosages of diazepam may cause cardiovascular depression. |
| Ephedrine | warnings and precautions | Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. |
| Epinephrine | warnings and precautions | If volume expansion with fluids plus other countermeasures do not correct hypotension, consider administration of pressor agents other than epinephrine. |
| Gabapentin | drug interactions | Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. … anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Glycine | contraindications | CONTRAINDICATIONS ULTIVA is contraindicated: For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13) ]. |
| Glycopyrrolate | warnings and precautions | Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. |
| Linezolid | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Methylene blue | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
Every other medicine the remifentanil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of ULTIVA and/or precipitate withdrawal symptoms. … treatment and institute alternative analgesic treatment. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine |
| Nalmefene | warnings and precautions | Resuscitative and intubation equipment, oxygen, and opioid overdose reversal agents (e.g., naloxone, nalmefene) must be readily available. |
| Naloxone | warnings and precautions | In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. |
| Pregabalin | drug interactions | Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. … relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Propofol | warnings and precautions | Intraoperative Awareness: Inoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min |
| Succinylcholine | drug interactions | … Drug Interactions In animals the duration of muscle paralysis from succinylcholine is not prolonged by remifentanil. |
| Tramadol | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Trazodone | drug interactions | Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat … |
Source: FDA drug label (Ultiva), Mylan Institutional LLC, effective December 15, 2025 (SPL set 4dbcb8f9-1987-4b66-bd2f-d251fda0be10), via openFDA; the full label on DailyMed
What do FAERS reports show for remifentanil?
The FDA Adverse Event Reporting System holds 2,362 reports that list remifentanil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 891 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 opioids
- the pharmacologic class, with prices and generics
- Remifentanil side effects
- the label's list beside FAERS reports
- Remifentanil shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other