Prescription medicine
Fentanyl First approved as Sublimaze
Fentanyl (Sublimaze) is a prescription medicine with an FDA approval on record since 1968. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.79 per mL (Fentanyl 100 mcg/2 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the fentanyl FDA label on DailyMed (effective March 6, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 16619 record on Drugs@FDA; every fentanyl label on DailyMed.
Highlights of the record
FDA label of March 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION.
Addiction, Abuse, and Misuse Because the use of Fentanyl 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 Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl 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. Reserve concomitant prescribing of Fentanyl Citrate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.4), Drug Interactions (7) ]. […]
Used for
From the label: indications and usageFentanyl Citrate Injection is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
Forms and strengths
- 2ml
- 0.05 mg/ml
Extended-release patch; injection; patch; injection (solution).
On the market
- Earliest approval on file
- February 19, 1968 Sublimaze Preservative Free, Rising; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first April 30, 1990; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 6 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- February 3, 2033 Ionsys system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.79 per mL Fentanyl 100 mcg/2 mL vial
- Shortage (FDA)
- 7 of 19 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 111 since 2012 10 Class I among all firms' recalls; latest September 3, 2026; 69 more by firms not listed as its makers
- FAERS reports
- 114,879 through July 30, 2026
What is fentanyl used for?
From the label: indications and usageFentanyl Citrate Injection is indicated for: analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. use as a narcotic analgesic supplement in general or regional anesthesia. administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. […]
Conditions named in the indications of fentanyl's FDA labels, with every medicine labeled for each:
From other fentanyl labelsPain: Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including …
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Fentanyl Citrate), Hikma Pharmaceuticals USA Inc., effective March 6, 2026 (SPL set ce5db1c2-feb1-4ad2-847a-d02e865bd47e), via openFDA; the full label on DailyMed
Is there a generic for fentanyl (Sublimaze)?
The FDA approved the first generic fentanyl on April 30, 1990. 20 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fentanyl from 6 labelers under a generic (ANDA) application and from 4 brand labelers. 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 Sublimaze Preservative Free injection; a patent listed only for Ionsys system runs to February 3, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1968 earliest approval on file
- 1990 first generic approved
- 2033 last listed patent
- 2012 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fentanyl (Sublimaze)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.79 per mL (Fentanyl 100 mcg/2 mL vial), up 76% from $1.01 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fentanyl 100 mcg/2 mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fentanyl 100 mcg/2 mL vial | Generic | $1.79 per mL | $3.57 per vial | +76% |
| Fentanyl 100 mcg/hr patch | Generic | $18.36 per patch | n/a | +1% |
| Fentanyl 12 mcg/hr patch | Generic | $8.99 per patch | n/a | -6% |
| Fentanyl 2,500 mcg/50 mL vial | Generic | $1.79 per mL | $89.32 per vial | +76% |
| Fentanyl 25 mcg/hr patch | Generic | $6.01 per patch | n/a | +8% |
| Fentanyl 250 mcg/5 mL vial | Generic | $1.79 per mL | $8.93 per vial | +76% |
| Fentanyl 37.5 mcg/hr patch | Generic | $35.03 per patch | n/a | -17% |
| Fentanyl 50 mcg/hr patch | Generic | $9.07 per patch | n/a | -7% |
| Fentanyl 62.5 mcg/hr patch | Generic | $57.69 per patch | n/a | n/a |
| Fentanyl 75 mcg/hr patch | Generic | $15.87 per patch | n/a | +16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is fentanyl in shortage?
The FDA Drug Shortage Database lists 7 of 19 fentanyl presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on January 1, 2012. 12 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-01) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-02) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-05) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-20) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Fentanyl Citrate Preservative Free, Injection, .05 mg/1 mL (NDC 63323-806-50) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Fentanyl Citrate, Injection, 100 mcg/2 mL (50 ug/1 mL) (NDC 0409-9094-22) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Fentanyl Citrate, Injection, 1000 mcg/20 mL (50 ug/1 mL) (NDC 0409-9094-31) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Fentanyl Citrate, Injection, 250 mcg/5 mL (50 ug/1 mL) (NDC 0409-9094-25) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fentanyl been recalled?
The FDA's Enforcement Report lists 180 recalls naming fentanyl since 2012: 10 Class I (the most serious), 163 Class II, 7 Class III; 12 still ongoing. 69 of them are by firms that FDA's NDC Directory does not list as a maker of fentanyl 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 |
|---|---|---|---|
| September 3, 2026 | Class II | OurPharma LLC | Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product … |
| May 12, 2026 | Class II | IntegraDose Compounding Services LLC not a listed maker | Subpotent Drug |
| April 1, 2026 | Class II | Wells Pharma of Houston LLC | cGMP deviations. |
| September 23, 2025 | Class II | Park Avenue Compounding not a listed maker | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. |
| April 15, 2025 | Class II | Apollo Care, LLC | Lack of Assurance of Sterility |
| January 31, 2025 | Class I | Alvogen, Inc | Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. |
| April 30, 2024 | Class III | Hikma Injectables USA Inc not a listed maker | Labeling: Wrong Barcode |
| February 29, 2024 | Class II | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Lack of Assurance of Sterility: Firm did not perform process validation. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fentanyl label say about other medicines?
The fentanyl label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name fentanyl. 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 Fentanyl Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine. |
| Butorphanol | drug interactions | Clinical Impact: May reduce the analgesic effect of Fentanyl Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine. |
| Carbamazepine | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of fentanyl, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to … 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 [see. … (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 | drug interactions | Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: The concomitant use of Fentanyl 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 Fentanyl 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 | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … Monitor for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice |
| Gabapentin | warnings and precautions | … non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). |
| Ketoconazole | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … 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 [see. … 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 [see. … 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 [see. … 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 [see. … 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 … |
| Nalbuphine | drug interactions | Clinical Impact: May reduce the analgesic effect of Fentanyl Citrate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Butorphanol, nalbuphine, pentazocine, buprenorphine. |
Every other medicine the fentanyl label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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 Fentanyl Citrate Injection. Intervention: Monitor patients for signs of cardiovascular depression that may be greater than otherwise expected. |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Fentanyl 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 Fentanyl Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of fentanyl, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to … monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Pregabalin | warnings and precautions | … general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). |
| Rifampin | drug interactions | CYP3A4 Inducers Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inducers can decrease the plasma concentration of fentanyl, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to … dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Inhibitors of CYP3A4 Clinical Impact: The concomitant use of Fentanyl Citrate Injection and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of … azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice |
| 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 [see. … 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 … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (…). Intervention: The use of Fentanyl 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 [see. … 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 … |
Other labels that name fentanyl
- Amiodarone
- Amitriptyline
- Amphetamine
- Citalopram
- Clomipramine
- Cobicistat
- Darunavir
- Deferasirox
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Duloxetine
- Enzalutamide
- Escitalopram
- Fluoxetine
- Fluvoxamine
- Fosamprenavir
- Isradipine
- Itraconazole
- Lenacapavir
- Letermovir
- Levomilnacipran
- Lisdexamfetamine
- Lithium
- Methamphetamine
- Midazolam
- Mifepristone
- Milnacipran
- Nevirapine
- Nifedipine
- Norepinephrine
- Nortriptyline
- Palbociclib
- Paroxetine
- Sertraline
- Trimipramine
- Venlafaxine
- Vilazodone
- Voriconazole
- Vortioxetine
- Ziprasidone
Source: FDA drug label (Fentanyl Citrate), Hikma Pharmaceuticals USA Inc., effective March 6, 2026 (SPL set ce5db1c2-feb1-4ad2-847a-d02e865bd47e), via openFDA; the full label on DailyMed
What do FAERS reports show for fentanyl?
The FDA Adverse Event Reporting System holds 114,879 reports that list fentanyl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 33,716 are coded as a death and 36,144 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 else is labeled for the same conditions as fentanyl?
1 other medicine is given the same way (transdermal) and in the same FDA class as fentanyl or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (transdermal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lidocaine | Pain | none listed | n/a | In shortage |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fentanyl compare with medicines for the same use?
3 side-by-side pages set fentanyl beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other opioids
- the pharmacologic class, with prices and generics
- Fentanyl side effects
- the label's list beside FAERS reports
- Fentanyl shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other