Prescription medicine
Sufentanil First approved as Sufenta
Sufentanil (Sufenta) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the sufentanil FDA label on DailyMed (effective June 1, 2026, Hospira, Inc.); the NDA 19050 record on Drugs@FDA; every sufentanil label on DailyMed.
Highlights of the record
FDA label of June 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION.
Addiction, Abuse, and Misuse Because the use of Sufentanil Citrate Injection 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 Sufentanil Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Sufentanil Citrate Injection 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. […]
Used for
From the label: indications and usageSufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- May 4, 1984 Sufenta Preservative Free, Rising; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 15, 1995; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- February 2, 2038 Dsuvia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 3 of 4 presentations limited or unavailable updated September 22, 2026
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest January 5, 2022; 7 more by firms not listed as its makers
- FAERS reports
- 1,247 through July 30, 2026
What is sufentanil used for?
From the label: indications and usageSufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. […]
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Sufentanil Citrate), Hospira, Inc., effective June 1, 2026 (SPL set 20293943-46ff-4345-1aa4-929b4e017a25), via openFDA; the full label on DailyMed
Is there a generic for sufentanil (Sufenta)?
The FDA approved the first generic sufentanil on December 15, 1995. 2 generic applications are approved; 1 of them 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 sufentanil from 1 labeler 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.
The Orange Book lists no patent for Sufenta Preservative Free injection; a patent listed only for Dsuvia tablets runs to February 2, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1984 earliest approval on file
- 1995 first generic approved
- 2038 last listed patent
- 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 sufentanil in shortage?
The FDA Drug Shortage Database lists 3 of 4 sufentanil presentations as limited or unavailable (updated September 22, 2026); the first entry was posted on May 3, 2022. 1 more presentation is on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sufentanil Citrate, Injection, 50 mcg/1 mL (NDC 17478-050-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Sufentanil Citrate, Injection, 50 mcg/1 mL (NDC 17478-050-02) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Sufentanil Citrate, Injection, 50 mcg/1 mL (NDC 17478-050-05) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Sufentanil Citrate, Injection, 50 ug/1 mL (NDC 0409-3382-21) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has sufentanil been recalled?
The FDA's Enforcement Report lists 8 recalls naming sufentanil since 2015: 0 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of sufentanil 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 |
|---|---|---|---|
| January 5, 2022 | Class II | Akorn, Inc. | Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. |
| December 20, 2019 | Class II | Assurance Infusion not a listed maker | Lack of sterility assurance. |
| April 20, 2016 | Class II | Pharmakon Pharmaceuticals, Inc. not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sufentanil label say about other medicines?
The sufentanil label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name sufentanil. 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 |
|---|---|---|
| Buprenorphine | drug interactions | Clinical Impact: May reduce the analgesic effect of Sufentanil Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of Sufentanil Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of Sufentanil Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of sufentanil, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| 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 inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and … |
| Diazepam | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: The concomitant use of Sufentanil Citrate Injection with CNS depressants may result in decreased pulmonary artery pressure and may cause hypotension. … Intervention: As postoperative analgesia, start with a lower dose of Sufentanil Citrate Injection and monitor patients for signs of respiratory depression, sedation, and hypotension. … |
| Epinephrine | warnings and precautions | If volume expansion with fluids plus other countermeasures do not correct hypotension, consider administration of pressor agents other than epinephrine. |
| Erythromycin | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice. |
| Fentanyl | warnings and precautions | Administration of sufentanil may produce muscular rigidity with a more rapid onset of action than that seen with fentanyl. |
| Gabapentin | drug interactions | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Ketoconazole | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice. |
| 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 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 inhibitors (those intended … |
Every other medicine the sufentanil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of Sufentanil Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants |
| Nalmefene | warnings and precautions | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical … |
| Naloxone | warnings and precautions | Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene), depending on the patient's clinical … |
| Nitrous oxide | drug interactions | Nitrous oxide Clinical Impact: Nitrous oxide has been reported to produce cardiovascular depression when given with higher doses of Sufentanil Citrate Injection. Intervention: Monitor patients for signs of cardiovascular depression that may be greater than otherwise expected. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Sufentanil Citrate Injection is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| Phenytoin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of Sufentanil Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of sufentanil, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | drug interactions | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of Sufentanil Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of sufentanil, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence … dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice. |
| Succinylcholine | warnings and precautions | Rare reports of bradycardia associated with the concomitant use of succinylcholine and sufentanil have been reported. |
| 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 inhibitors (those intended to treat psychiatric … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Sufentanil Citrate Injection is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Examples: phenelzine, tranylcypromine, linezolid |
| 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 inhibitors (those intended to treat … |
Other labels that name sufentanil
Source: FDA drug label (Sufentanil Citrate), Hospira, Inc., effective June 1, 2026 (SPL set 20293943-46ff-4345-1aa4-929b4e017a25), via openFDA; the full label on DailyMed
What do FAERS reports show for sufentanil?
The FDA Adverse Event Reporting System holds 1,247 reports that list sufentanil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 179 are coded as a death and 499 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
- Sufentanil side effects
- the label's list beside FAERS reports
- Sufentanil shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other