Skip to the answer

Fentanyl

Fentanyl is a strong opioid pain medicine used for severe, ongoing pain in people already tolerant to opioids, for breakthrough cancer pain, and for pain control during and right after anesthesia and surgery, depending on the product.

Brand names AbstralActiqFentoraOnsolisSubsys +3 more
Drug class Opioid Agonist
Rx Schedule CII Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Other forms & routes:
Transdermal
Fentanyl at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Fentanyl is a very potent opioid that dulls pain through the brain's opioid receptors, a specialist drug for people already tolerant to opioids (patches for severe, persistent pain, lozenges for breakthrough cancer pain) and an injection around surgery, on the market since about 1984 and available as a generic. Nausea, sleepiness and constipation are what most people notice, as with other strong opioids. The boxed warning covers addiction, misuse and life-threatening slowed breathing, riskiest when starting or raising the dose, and a single lozenge or even a used patch can be fatal to a child. Keep it locked up, with naloxone (an overdose reversal medicine) at home.

Clinical pearls

  • Heating pads, electric blankets and fever all push more fentanyl through the skin, so keep heat off a worn patch.
  • Alcohol, benzodiazepines, gabapentin, pregabalin, muscle relaxants and sleep aids can stack with fentanyl into dangerous, even fatal, sedation.
  • Grapefruit juice, erythromycin, ketoconazole and ritonavir can push fentanyl levels up, so skip grapefruit and flag any new prescription.
  • Fentanyl products are not interchangeable, so never swap a patch, lozenge or spray for another one on your own.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

The boxed warning here applies to fentanyl lozenges (OTFC). These can cause fatal slowed breathing, and they are only for people already tolerant to opioids.

  • Addiction, abuse and misuse can lead to overdose and death.
  • Accidental ingestion of even one dose, especially by a child, can be fatal. Keep out of reach of children.
  • Combining with benzodiazepines, alcohol or other CNS depressants can cause profound sedation, coma and death.
  • Lozenges are not the same as other fentanyl products, and swapping between them can cause fatal overdose.
  • CYP3A4-inhibiting drugs can raise fentanyl levels and cause dangerous breathing problems.
  • Lozenges are not for sudden or after-surgery pain, including headache or migraine.
  • They are available only through a restricted program called the TIRF REMS.
  • Long-term use in pregnancy can cause life-threatening withdrawal in the newborn.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asSkin patch, Injection
Earliest FDA record1968
Companies listing it with the FDA10
FDA label last updatedDec 15, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Fentanyl, written from its FDA label.

What Fentanyl is used for

▾

Fentanyl is used for different kinds of pain depending on the product.

  • Fentanyl transdermal system (skin patch): severe, persistent pain in opioid-tolerant people that other options cannot manage.
  • Oral transmucosal fentanyl citrate (OTFC) lozenge: breakthrough cancer pain in people 16 and older already tolerant to around-the-clock opioids.
  • Fentanyl Citrate Injection: short-acting pain relief during anesthesia and in the recovery room.
  • Fentanyl Citrate Injection: an opioid pain medicine supplement in general or regional anesthesia, and an anesthetic with oxygen in selected high-risk surgeries.

How Fentanyl works

▾

Fentanyl is an opioid agonist. It binds mainly to mu-opioid receptors found in the brain, spinal cord and other tissues. This changes how the body senses pain. The same action can slow breathing and the gut.

Fentanyl dosage

▾

How fentanyl is taken depends on the form.

  • Skin patch: worn on the skin for about 72 hours.
  • Lozenge: dissolves in the mouth for breakthrough cancer pain, used with around-the-clock opioids.
  • Injection: given into a vein or muscle by trained staff.

Your prescriber individualizes the dose and aims for the lowest effective amount for the shortest time. Follow your prescriber and the Medication Guide.

Dosing details from the FDA-approved label

From the Fentanyl prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Premedication in Adults (Fentanyl Citrate Injection)
    • 50 mcg to 100 mcg may be administered intramuscularly 30 to 60 minutes prior to surgery
  • Adjunct to General Anesthesia - Low Dose (total dosage)
    • 2 mcg/kg
    • For minor, but painful, surgical procedures
    • Maintenance: additional dosages infrequently needed
  • Adjunct to General Anesthesia - Moderate Dose (total dosage)
    • 2 mcg/kg to 20 mcg/kg
    • Maintenance 25 mcg to 100 mcg intravenously or intramuscularly as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia
  • Adjunct to General Anesthesia - High Dose (total dosage)
    • 20 mcg/kg to 50 mcg/kg
    • Maintenance ranging from 25 mcg to one half the initial loading dose as needed based on vital signs indicative of stress and lightening of analgesia
    • Individualize the dosage especially if the anticipated remaining operative time is short
  • Adjunct to Regional Anesthesia
    • 50 mcg to 100 mcg may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required
  • Postoperatively (recovery room)
    • 50 mcg to 100 mcg may be administered intramuscularly for the control of pain, tachypnea and emergence delirium
    • The dose may be repeated in one to two hours as needed
  • Induction and Maintenance in Children 2 to 12 Years of Age
    • A reduced dose as low as 2 mcg/kg to 3 mcg/kg is recommended
    • Children 2 to 12 years of age
  • As a General Anesthetic
    • 50 mcg/kg to 100 mcg/kg may be administered with oxygen and a muscle relaxant
    • Maximum: In certain cases, doses up to 150 mcg/kg may be necessary
  • Fentanyl transdermal system (patch)
    • Each transdermal system is intended to be worn continuously for up to 72 hours
    • Initial dose selection per conversion instructions
    • Mild to moderate hepatic and renal impairment: initiate with one half the usual starting dose
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Fentanyl transdermal system should be prescribed only by healthcare providers who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of fentanyl transdermal system for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with fentanyl transdermal system. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with fentanyl transdermal system, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.4 ) Initial dose selection: consult conversion instructions. ( 2.3 ) Periodically reassess patients receiving fentanyl transdermal system to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.4 ) Each transdermal system is intended to be worn continuously for up to 72 hours. ( 2.3 , 2.7 ) Adhere to instructions concerning administration and disposal of fentanyl transdermal system. ( 2.7 , 2.8 ) Mild to moderate hepatic and renal impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Fentanyl side effects

▾

Common side effects of fentanyl include:

Common side effects

  • Nausea
  • Vomiting
  • Dizziness
  • Sleepiness (somnolence)
  • Weakness (asthenia)
  • Headache
  • Constipation
  • Shortness of breath

When to get medical help

  • Call 911 right away for slow or shallow breathing, extreme sleepiness, trouble waking, cold and clammy skin or pinpoint pupils. These can be signs of overdose.
  • Get emergency help if a child or another person is accidentally exposed to a patch or lozenge.
  • Seek help for signs of a serious allergic reaction (anaphylaxis).
  • Seek help for possible serotonin syndrome, a potentially life-threatening reaction when fentanyl is combined with serotonergic drugs.
  • Tell your doctor about severe dizziness or fainting from low blood pressure.
  • Tell your doctor if your pain gets worse or you become more sensitive to pain while on the medicine (opioid-induced hyperalgesia).
  • Tell your doctor about signs of adrenal insufficiency (when the adrenal glands don't make enough hormones), which can occur with opioid use.
  • Tell your doctor right away about seizures or signs of a bowel blockage.

Fentanyl warnings and precautions

▾
  • Slowed breathing can be fatal, especially when starting or raising the dose.
  • Addiction, abuse and misuse can happen even when taken as prescribed.
  • Accidental exposure, especially in children, can cause death. Store and dispose of patches and lozenges carefully.
  • Mixing with alcohol, benzodiazepines or other sedatives is dangerous.
  • Fever or heat on a patch can increase absorption.
  • Long-term use in pregnancy can cause newborn withdrawal.

Fentanyl interactions

▾

Several drugs and substances can change how fentanyl works or add to its risks.

  • Alcohol, benzodiazepines and other sedatives: profound sedation and slowed breathing.
  • CYP3A4 inhibitors (erythromycin, ketoconazole, ritonavir, grapefruit juice): higher fentanyl levels.
  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin): lower levels, and higher levels when stopped.
  • Serotonergic drugs and MAO inhibitors: serotonin syndrome or opioid toxicity.
  • Buprenorphine, butorphanol, nalbuphine, pentazocine: weaker pain relief or withdrawal.
  • Anticholinergic drugs: urinary retention and severe constipation.

Interactions listed in the FDA-approved label

From the Fentanyl prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, ritonavir, grapefruit juice): Can increase fentanyl plasma concentration, resulting in increased or prolonged opioid effects; after stopping the inhibitor, concentration decreases, with decreased efficacy or withdrawal in physically dependent patients. If concomitant use is necessary, consider dosage reduction until stable drug effects are achieved and monitor for respiratory depression and sedation at frequent intervals; if the inhibitor is discontinued, consider increasing the dosage and monitor for opioid withdrawal.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Can decrease fentanyl plasma concentration, resulting in decreased efficacy or withdrawal in physically dependent patients; after stopping the inducer, concentration will increase and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the dosage until stable effects are achieved and monitor for withdrawal; if the inducer is discontinued, consider dosage reduction and monitor for respiratory depression.
  • Benzodiazepines and other CNS depressants: May result in decreased pulmonary artery pressure and hypotension; as postoperative analgesia can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. As postoperative analgesia, start with a lower dose, monitor for respiratory depression, sedation, and hypotension, and have fluids or other measures to counter hypotension available.
  • Serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, etc.): Concomitant use of opioids with drugs affecting the serotonergic system has resulted in serotonin syndrome. If concomitant use is warranted, observe the patient carefully, particularly during initiation and dose adjustment; discontinue if serotonin syndrome is suspected.
  • Monoamine oxidase inhibitors (phenelzine, tranylcypromine, linezolid): MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants: Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor for respiratory depression that may be greater than expected and decrease the dosage of fentanyl and/or the muscle relaxant as necessary.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor for signs of diminished diuresis and/or effects on blood pressure and increase the diuretic dosage as needed.
  • Anticholinergic drugs: May increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility.
  • Neuroleptics: Elevated blood pressure, with and without pre-existing hypertension, has been reported following administration of fentanyl combined with a neuroleptic. ECG monitoring is indicated when a neuroleptic is used with fentanyl as an anesthetic premedication, for induction, or as an adjunct in maintenance of general or regional anesthesia.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with fentanyl transdermal system. Table 6: Clinically Significant Drug Interactions with Fentanyl Transdermal System Inhibitors of CYP3A4 Clinical Impact: The concomitant use of fentanyl transdermal system 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 fentanyl transdermal system is achieved [see Warnings and Precautions ( 5.7 ) ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the fentanyl transdermal system plasma concentration will decrease [see Clinical Pharmacology ( 12.3 ) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl. Intervention: If concomitant use is necessary, consider dosage reduction of fentanyl transdermal system until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the fentanyl transdermal system dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice. CYP3A4 Inducers Clinical Impact: The concomitant use of fentanyl transdermal system and CYP3A4 inducers can decrease the plasma concentration of fentanyl [see Clinical Pharmacology ( 12.3 ) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to fentanyl [see Warnings and Precautions ( 5.7 ) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿226 supplements and herbs with documented Fentanyl interactions, ranked by severity Check Fentanyl against a supplement or herb →

Before taking Fentanyl

▾
  • Patches and lozenges are only for opioid-tolerant people.
  • Not for mild, short-term, or after-surgery pain.
  • Do not use with significant breathing problems, severe asthma in an unmonitored setting, or bowel blockage.
  • Tell your doctor about substance abuse or mental illness history.
  • Pregnancy: risk of newborn withdrawal; not recommended around labor (patch).
  • Breastfeeding is not recommended with the patch.
  • Older adults need slow dose adjustment and close monitoring.
  • Severe liver or kidney impairment: patch use not recommended.

Fentanyl overdose

▾

Overdose can cause slowed breathing, extreme sleepiness progressing to coma, limp muscles, cold and clammy skin and pinpoint pupils. Call 911 right away. Treatment focuses on airway and breathing support and an overdose reversal medicine like naloxone, and with a patch, all patches must be removed and monitoring may continue for days.

What Fentanyl does in the body

▾

Fentanyl acts on mu-opioid receptors to relieve pain. It also directly reduces the brain's drive to breathe. It slows the gut, causing constipation, and can widen blood vessels, leading to low blood pressure or fainting. Long-term use may lower sex hormone levels.

How your body processes Fentanyl

▾

With the patch, fentanyl is released steadily through the skin, with levels leveling off after 12 to 24 hours. After removal, levels fall by about half in roughly 20 to 27 hours. Fentanyl is mainly broken down by the CYP3A4 enzyme into inactive substances. Heat over the patch increases absorption.

How to store Fentanyl

▾

Store in original unopened pouch. Store at 20° to 25°C (68° to 77°F). Store fentanyl transdermal system securely and dispose of properly .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

226

Supplements & herbs that interact with Fentanyl

226 supplements and herbal products have documented interactions with Fentanyl in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 10
  • Moderate · 176
  • Minor · 40
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major LITHIUM Major +218 more
Every supplement checked against Fentanyl — ranked by severity The full interaction hub: 10 major · 176 moderate · 40 minor · every one linked to its full report. Check Fentanyl against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Fentanyl: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Fentanyl — the kind of thing our pharmacy team would talk through with you at the counter.

What is fentanyl used for?

▾
It depends on the form. The patch treats severe, ongoing pain in people already used to opioids. The lozenge treats breakthrough cancer pain, and the injection is used by anesthesia teams around surgery.

Can I use fentanyl if I've never taken opioids?

▾
No. The patch and lozenge are only for people who are already opioid-tolerant. In someone who isn't, they can cause dangerous or fatal slowed breathing.

Can I drink alcohol or take sleep medicines with it?

▾
Please don't without checking with me or your doctor. Alcohol, benzodiazepines and other sedating medicines can cause profound sleepiness, slowed breathing and death.

How do I store and throw away patches or lozenges safely?

▾
Keep them out of children's reach, since even one dose can be fatal for a child. Dispose of used patches exactly as the instructions say, because a lot of drug remains in them. Ask me about naloxone to keep at home.

What side effects are normal, and when should I get help?

▾
Nausea, dizziness, sleepiness, constipation and headache are common. Call 911 for slow or shallow breathing, trouble waking, or cold, clammy skin. Also call for allergic reactions or seizures.

Is it safe in pregnancy or while breastfeeding?

▾
Long-term use in pregnancy can cause withdrawal in the newborn, so talk to your doctor early. The patch is not recommended while breastfeeding because fentanyl passes into milk and can sedate the baby.

Is Fentanyl available over the counter?

▾
No. Fentanyl is a prescription medicine: every Fentanyl product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Fentanyl a controlled substance?

▾
Yes — Fentanyl is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Fentanyl first available?

▾
The earliest FDA record we hold for Fentanyl is from 1968: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fentanyl was first used.

Who makes Fentanyl?

▾
10 companies currently list Fentanyl products in the FDA's NDC Directory, including Hikma Pharmaceuticals USA Inc., Aveva Drug Delivery Systems Inc., Ingenus Pharmaceuticals, Llc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fentanyl on HelloPharmacist

📊Fentanyl supplement interactions226 checked — ranked by severity 🌿Drug & Supplement CheckerFentanyl vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fentanyl NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Fentanyl Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Fentanyl forms and strengths (how it comes)

Fentanyl is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Skin patch

Through the skin
Brands Fentanyl System Fentanyl Transdermal
How this form is used
What it may be used for
  • Fentanyl transdermal system treats severe, persistent pain in opioid-tolerant people when other options, including immediate-release opioids, are not enough.
  • Fentanyl transdermal system is not for as-needed use.
Important instructions
  • Fentanyl transdermal system releases fentanyl through the skin over a 72-hour application period.
  • Fentanyl transdermal system should be dosed at the lowest effective dose for the shortest time.
  • Fentanyl transdermal system must not be placed in the mouth, chewed or swallowed, and used patches must be disposed of exactly as directed.
  • Fentanyl transdermal system absorption increases with heat or fever, so avoid heat over the patch.
Available strengths 23 strengths
12 mcg/h FENTANYL 12 mcg/h 12.5 mcg 12.5 mcg/h FENTANYL 12.5 mcg/h 25 mcg
Show 17 more strengths Show fewer strengths
25 mcg/h FENTANYL 25 mcg/h 37.5 mcg/h FENTANYL 37.5 mcg/h 50 mcg 50 mcg/h FENTANYL 50 mcg/h 62.5 mcg/h FENTANYL 62.5 mcg/h 75 mcg 75 mcg/h FENTANYL 75 mcg/h 87.5 mcg/h FENTANYL 87.5 mcg/h 100 mcg 100 mcg/h FENTANYL 100 mcg/h
76 FDA-listed product records ⓘ

Injection

By injection · Into a muscle · Into a vein
How this form is used
What it may be used for
  • Fentanyl Citrate Injection provides short-acting pain relief during anesthesia, premedication and recovery after surgery.
  • Fentanyl Citrate Injection is used as an opioid pain medicine supplement in general or regional anesthesia.
  • Fentanyl Citrate Injection is used as an anesthetic with oxygen in selected high-risk patients, such as those having open heart surgery.
Important instructions
  • Fentanyl Citrate Injection is given only by people trained in IV anesthetics and managing breathing effects of strong opioids.
  • Fentanyl Citrate Injection dosing is individualized, and reversal medicine and resuscitation equipment must be on hand.
Available strengths 4 strengths
0.05 mg/mL 50 mcg/mL 100 mcg/2 mL 10 mg/mL
50 FDA-listed product records ⓘ

Fentanyl on the U.S. market: products, makers and brands

How Fentanyl appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

10 companies list 54 Fentanyl product records with the FDA, mostly as skin patch, injection; the earliest marketing or approval year on record is 1968. Brand names on the directory include Abstral, Actiq, Fentora and 5 more; the rest are generics.

2
Dose forms ⓘ
10
Labelers (makers, repackagers, distributors)
4
Brand names
54
FDA-listed product records ⓘ
1968
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (28) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hikma Pharmaceuticals USA Inc.17%
Aveva Drug Delivery Systems Inc.15%
Ingenus Pharmaceuticals, Llc15%
Mylan Pharmaceuticals Inc.15%
SpecGx LLC13%
Alvogen9%
Other makers17%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Fentanyl is used (Medicaid data)

A general measure of how commonly Fentanyl is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fentanyl is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

440,395
Medicaid prescriptions filled (Q1–Q4 2025)
$49.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fentanyl prescribed? Of the 1,601 medications we measure, Fentanyl ranks #276 by Medicaid prescriptions — more than 83% of them.

Where Fentanyl ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #276 of 1,601
#271 Nortriptyline 455,288 Rx #272 Carbamazepine 452,754 Rx #273 Penicillin V Potassium 451,965 Rx #274 Viloxazine 451,086 Rx #275 Omega-3-Acid Ethyl Est... 450,937 Rx #276 Fentanyl 440,395 Rx #277 Formoterol / Mometason... 440,187 Rx #278 Ziprasidone 438,206 Rx #279 Ciclopirox Topical 437,507 Rx #280 Diltiazem 435,096 Rx #281 Warfarin 433,961 Rx

Utilization by Fentanyl product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2 mL / 0.05 mg/mL injection is the most-dispensed Fentanyl product — about 75% of these Medicaid prescriptions.

2 ML fentanyl 0.05 MG/ML Injection Most dispensed

328,683 Medicaid prescriptions (Q1–Q4 2025) 75% of Fentanyl prescriptions shown $39.3M gross reimbursement (before rebates) ≈ $119 per prescription (gross)

Summed across the 6 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1735003

72 HR fentanyl 0.025 MG/HR Transdermal System

25,160 Medicaid prescriptions (Q1–Q4 2025) 6% of Fentanyl prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $52 per prescription (gross)

Summed across the 4 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 245134

1 ML fentanyl 0.05 MG/ML Injection

21,651 Medicaid prescriptions (Q1–Q4 2025) 5% of Fentanyl prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2168270

72 HR fentanyl 0.05 MG/HR Transdermal System

15,342 Medicaid prescriptions (Q1–Q4 2025) 3% of Fentanyl prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $82 per prescription (gross)

Summed across the 4 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 245135

72 HR fentanyl 0.012 MG/HR Transdermal System

12,632 Medicaid prescriptions (Q1–Q4 2025) 3% of Fentanyl prescriptions shown $1M gross reimbursement (before rebates) ≈ $82 per prescription (gross)

Summed across the 4 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577057

5 ML fentanyl 0.05 MG/ML Injection

12,472 Medicaid prescriptions (Q1–Q4 2025) 3% of Fentanyl prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $111 per prescription (gross)

Summed across the 5 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1735007

72 HR fentanyl 0.1 MG/HR Transdermal System

8,527 Medicaid prescriptions (Q1–Q4 2025) 2% of Fentanyl prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $180 per prescription (gross)

Summed across the 4 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 245136

72 HR fentanyl 0.075 MG/HR Transdermal System

7,156 Medicaid prescriptions (Q1–Q4 2025) 2% of Fentanyl prescriptions shown $895,138 gross reimbursement (before rebates) ≈ $125 per prescription (gross)

Summed across the 4 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197696

1 ML fentanyl 0.05 MG/ML Prefilled Syringe

5,311 Medicaid prescriptions (Q1–Q4 2025) 1% of Fentanyl prescriptions shown $515,289 gross reimbursement (before rebates) ≈ $97 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2474269

72 HR fentanyl 0.0375 MG/HR Transdermal System

1,085 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $379,740 gross reimbursement (before rebates) ≈ $350 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1603495

50 ML fentanyl 0.05 MG/ML Injection

747 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $104,310 gross reimbursement (before rebates) ≈ $140 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1735013

10 ML fentanyl 0.05 MG/ML Injection

720 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $591,522 gross reimbursement (before rebates) ≈ $822 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1735006

2 ML fentanyl 0.05 MG/ML Prefilled Syringe

428 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $107,828 gross reimbursement (before rebates) ≈ $252 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2474267

20 ML fentanyl 0.05 MG/ML Injection

274 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $2,537 gross reimbursement (before rebates) ≈ $9.26 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1735008

72 HR fentanyl 0.0625 MG/HR Transdermal System

77 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $30,874 gross reimbursement (before rebates) ≈ $401 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1603498

0.5 ML fentanyl 0.05 MG/ML Prefilled Syringe

55 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $264 gross reimbursement (before rebates) ≈ $4.80 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2629337

Other Fentanyl products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

75 Medicaid prescriptions (Q1–Q4 2025) <1% of Fentanyl prescriptions shown $9,892 gross reimbursement (before rebates) ≈ $132 per prescription (gross)

Summed across the 1 of 129 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fentanyl, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 49 of 320 listed Fentanyl NDCs with Medicaid activity.

Compare Fentanyl products

A representative set of FDA-listed product records for Fentanyl — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 54 of 54 products — FDA National Drug Code Directory. See every product, package size and price: browse all 54 Fentanyl NDCs →

Fentanyl recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Fentanyl recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class I Jan 31, 2025 · Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
  • Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery… Lots: Lot #: 108319, Exp: 04/30/2027 FDA record D-0245-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fentanyl RxCUI 4337 10 dose forms · 47 strengths
  1. Dose form (SCDF) Buccal Film RxCUI 858086 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG RxCUI 858092 0.4 MG RxCUI 858095 0.6 MG RxCUI 858098 0.8 MG RxCUI 858101 1.2 MG RxCUI 858087
  2. Dose form (SCDF) Buccal Tablet RxCUI 668362 No current FDA listing
    Clinical drug / strength (SCD) 0.1 MG RxCUI 668363 0.2 MG RxCUI 668364 0.3 MG RxCUI 706898 0.4 MG RxCUI 668365 0.6 MG RxCUI 668366 0.8 MG RxCUI 668367
  3. Dose form (SCDF) Cartridge RxCUI 1734964 No current FDA listing
    Clinical drug / strength (SCD) 2 ML fentanyl 0.05 MG/ML RxCUI 727759
  5. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 2201610 No current FDA listing
  6. Dose form (SCDF) Mucosal Spray RxCUI 1237049 No current FDA listing
    Clinical drug / strength (SCD) 0.1 MG/ACTUAT RxCUI 1237050 0.2 MG/ACTUAT RxCUI 1237057 0.4 MG/ACTUAT RxCUI 1237060 0.8 MG/ACTUAT RxCUI 1237068
  7. Dose form (SCDF) Oral Lozenge RxCUI 372161 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG RxCUI 310295 0.3 MG RxCUI 310296 0.4 MG RxCUI 310297 0.6 MG RxCUI 313992 0.8 MG RxCUI 313993 1.2 MG RxCUI 310293 1.6 MG RxCUI 310294
  9. Dose form (SCDF) Sublingual Tablet RxCUI 1053646 No current FDA listing
    Clinical drug / strength (SCD) 0.1 MG RxCUI 1053647 0.2 MG RxCUI 1053652 0.3 MG RxCUI 1053655 0.4 MG RxCUI 1053658 0.6 MG RxCUI 1053661 0.8 MG RxCUI 1053664

Look up RxCUI 4337 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Fentanyl costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Patch · Transdermal 12.5 mcg $8.99 each NDC details & price history
Patch · Transdermal 25 mcg $6.01 each NDC details & price history
Patch · Transdermal 100 mcg $18.36 each NDC details & price history
Patch · Transdermal 50 mcg $9.07 each NDC details & price history
Patch · Transdermal 75 mcg $15.87 each NDC details & price history
Patch · Transdermal 62.5 mcg/h $57.69 each NDC details & price history
Patch · Transdermal 50 mcg/h $9.07 each NDC details & price history
Patch · Transdermal 75 mcg/h $15.87 each NDC details & price history
Patch, Extended Release · Transdermal FENTANYL 100 mcg/h $18.36 each NDC details & price history
Patch, Extended Release · Transdermal FENTANYL 62.5 mcg/h $57.69 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Fentanyl brand names

Fentanyl is sold under 8 brand names in the FDA directory — Abstral, Actiq, Fentora, Onsolis and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Abstral Actiq Fentora Onsolis Subsys Ionsys Fentanyl Transdermal Fentanyl System

Who makes Fentanyl: manufacturers and labelers

10 companies list Fentanyl products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Aveva Drug Delivery Systems Inc., Ingenus Pharmaceuticals, Llc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hikma Pharmaceuticals USA Inc. 9 Aveva Drug Delivery Systems Inc. 8 Ingenus Pharmaceuticals, Llc 8 Mylan Pharmaceuticals Inc. 8 SpecGx LLC 7 Alvogen 5 Civica, Inc. 3 Fresenius Kabi USA, LLC 3 Hospira, Inc. 2 Phlow Corp. 1

Fentanyl drug class (RxNorm)

Fentanyl belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opioid anesthetics, Phenylpiperidine derivatives
How it works Full Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Fentanyl page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 15, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fentanyl.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fentanyl after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
Finished products in the current FDA directory
54
Companies listing them (makers, repackagers, distributors)
10
FDA labeler codes behind them ⓘ
10
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Dec 15, 2025
Composite sections available
25
Linked SPL Set ID
2a2238e9-4b5d-c56d-8663-dd354ff9ae0c
Linked SPL Document ID
a6e21c86-57e5-4be5-b1bb-c894893991b2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →