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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: fentanyl [patch] (FEN ta nil)
Brand name(s): DURAGESIC, IONSYS
GENERIC: not available FAMILY: Opiate-containing Painkillers
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Fentanyl caused fetal death in animal studies. Because of the potential for serious adverse effects to the fetus, this drug should not be used by pregnant women.

Breast-feeding Warning

Fentanyl is excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]


Addiction, Abuse, and Misuse

DURAGESIC 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 DURAGESIC, and monitor all patients regularly for the development of these behaviors and conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DURAGESIC. Monitor for respiratory depression, especially during initiation of DURAGESIC or following a dose increase. Because of the risk of respiratory depression, DURAGESIC is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain.

Accidental Exposure

Accidental exposure to even one dose of DURAGESIC, especially in children, can result in a fatal overdose of fentanyl. Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to DURAGESIC. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DURAGESIC during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of DURAGESIC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving DURAGESIC and any CYP3A4 inhibitor or inducer.

Risk of Increased Fentanyl Absorption with Application of External Heat

Exposure of the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources.

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 DURAGESIC and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit treatment to the minimum effective dosages and durations.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Facts About This Drug [top]

Fentanyl is a synthetic narcotic that relieves pain. Most studies about fentanyl focus on the injectable form used during surgery. Fewer studies have been done on the transdermal (patch) form, and even fewer studies have been done on older people using fentanyl patches.

Fentanyl patches, which slowly release medication over three days, are used for persistent, moderate-to-severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be...

Fentanyl is a synthetic narcotic that relieves pain. Most studies about fentanyl focus on the injectable form used during surgery. Fewer studies have been done on the transdermal (patch) form, and even fewer studies have been done on older people using fentanyl patches.

Fentanyl patches, which slowly release medication over three days, are used for persistent, moderate-to-severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be managed by other means.[1] Pain relief usually improves sleep. People with swallowing difficulties or poor veins benefit from the topical application. Others find the patch convenient. However, fentanyl is not a Band-Aid for mild or intermittent pain and usually is not used until doses of oral morphine have become high and frequent.

Using cut or damaged patches can cause a high dose of the drug to be released and absorbed, which can be fatal. The first dose of fentanyl is usually 25 micrograms (this refers to the number of micrograms released each hour). Doses must be estimated according to prior use of other analgesics. Older people usually need less fentanyl than younger people. It may take a few days until adequate pain relief is achieved. During the transition, other shorter-acting analgesics relieve breakthrough pain. One drawback of the patches is less flexibility in doses—the patches are currently limited to four sizes and their combinations. People who lose weight may need to have their dose lowered, since fentanyl is stored in fat tissue. Fentanyl should not be used on as-needed basis.

Fentanyl is not recommended for those weighing less than 110 pounds. Common adverse effects of fentanyl are nausea, vomiting, constipation and skin irritation from the adhesive on the patch. Fentanyl patches are not recommended after surgery due to risk of severe respiratory problems. Like morphine, fentanyl is a controlled substance and could be habit-forming. The cost of fentanyl patches is higher than the cost of short-acting oral morphine, similar to long-acting oral morphine, and usually less expensive than injectable morphine, which involves costs for supplies and equipment.

In 2005, the Food and Drug Administration (FDA) issued a Public Health Advisory and added extensive safety warnings to the professional product label of fentanyl in response to reports of death linked to the use of the fentanyl transdermal patch. The new warnings identify several important safety precautions, which are described below.

Fentanyl skin patches should not be used in the following situations:

  • in patients who have not previously been prescribed opioid painkillers
  • in the management of acute pain or in patients who require opioid pain killers only for a short period of time
  • in the management of post-operative pain, including use after out-patient or same-day surgeries
  • in the management of mild pain
  • in the management of intermittent pain

Fentanyl skin patches also interact with a number of drugs that can increase the amount of fentanyl in the blood to dangerous levels. These drugs include ritonavir (KALETRA, NORVIR), ketoconazole (NIZORAL), itraconazole (SPORANOX), troleandomycin (TAO), clarithromycin (BIAXIN), nelfinavir (VIRACEPT) and nefazodone (SERZONE).

In 2007, the FDA issued another update concerning the appropriate prescribing, dose selection and safe use of the patch. The FDA continues to receive reports of death and life-threatening adverse events associated with fentanyl use.[2]

There have been several reports of serious adverse effects, including death, in patients associated with the buccal (mouth-absorbing) formulation of fentanyl, Fentora. In 2007 the FDA issued a public health advisory highlighting these reports and required that the manufacturer update the label and Medication Guide with additional information on the safe use of Fentora.[3]

In 2010, Prescrire International published an article concerning the risk of drug overdose associated with fentanyl patches. The data reviewed in the article indicated that a potentially fatal overdose of fentanyl may be avoided if the special safety precautions for use and disposal are followed.[4] A copy of the FDA-approved Medication Guide is available here: www.fda.gov/cder/drug/InfoSheets/patient/fentanylPIS.htm.

In 2013, the manufacturer of a fentanyl patch in the UK and the Medicines and Healthcare products Regulatory Agency (MHRA, an agency in the UK similar to the FDA) issued information that serotonin syndrome (see below), a potentially life-threatening condition, can occur when fentanyl-containing products are co-administered with other serotonergic medications (selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors and drugs that impair the metabolism of serotonin [including monoamine oxidase inhibitors]).[5]

The symptoms of serotonin syndrome are:

  • restlessness
  • hallucinations
  • loss of coordination
  • fast heartbeat
  • increased body temperature
  • rapid changes in blood pressure
  • overactive reflexes
  • diarrhea
  • coma
  • nausea
  • vomiting

In 2013, Health Canada issued safety information on the risk of accidental exposure to the fentanyl patch and on the importance of safe use and disposal of the patch to help prevent accidental exposure.[6]

In 2012, Public Citizen filed a petition with the FDA requesting changes in the drug labeling for opioid pain medications in an effort to reduce the massive overprescribing of these medications. The petition states that opioid labels are especially broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Currently, the labels on opioid analgesics simply state that they are approved for moderate-to-severe pain. The petition calls for striking the term “moderate,” inserting a suggested duration of use and adding a suggested maximum dose equivalent of 100 milligrams of morphine. The requested changes relate only to opioids used for non-cancer pain.

If the requested changes are adopted, drug companies no longer would be able to promote these pain medications as safe and effective for long-term use by non-cancer patients.[7]

In 2013, the FDA approved labeling changes to the fentanyl patch (brand name: DURAGESIC) used to treat pain in an effort to prevent accidental exposure in children. Since 1997, the FDA has received 32 reports of accidental exposure to fentanyl patches, most of which involved children younger than 2 years. Twelve children have died from exposure, and 12 more were hospitalized but did not die.[8]

The FDA required color changes to the writing on DURAGESIC pain patches so it can be seen more easily. In an effort to minimize the risk of accidental exposure to fentanyl patches, the FDA requires the manufacturer of DURAGESIC to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The FDA continues to learn of deaths from accidental exposure to fentanyl patches.[9]

Patients experiencing MOHs should discuss with their doctors the important details of their headaches and, depending on their individual case, the type of withdrawal from the MOH-causing drugs that is best.[10]

2016: The FDA issued a safety warning for the entire opioid class of drugs concerning potential harmful interactions with other medications, problems with the adrenal glands and decreased sex hormone levels.

The FDA required the addition of a black-box warning, the agency’s strongest warning, to opioid and benzodiazepine drug labels stating that profound sedation, depressed breathing, coma and death can occur when these medications are used together.[11]

Before You Use This Drug [top]

Do not use if you have or have had:

  • diarrhea
  • respiratory depression
  • are breast-feeding

Tell your doctor if you have or have had:

  • allergies to medications or adhesives
  • emphysema, asthma, or other lung problems
  • colitis or inflammatory bowel disease
  • alcohol or drug abuse
  • gallbladder problems
  • head injuries or brain tumor
  • coma
  • kidney or liver problems
  • gastrointestinal problems
  • thyroid problems
  • slow heartbeat
  • emotional problems
  • suicidal ideation or attempt
  • enlarged prostate or difficulty urinating
  • recent urinary tract surgery
  • pregnancy or are breast-feeding
  • not opioid tolerant
  • fever

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Read the patient instructions carefully before using.
  • To avoid constipation, drink plenty of water or fluids. Eat fiber. Take a stool softener. If constipation develops, you may need a laxative or enema.
  • Do not use more than directed by your doctor; it may take 24 hours before effects are felt.
  • Until you know how you react to fentanyl, avoid driving or performing other activities requiring alertness, as fentanyl can cause drowsiness.
  • Avoid drinking alcohol, which adds to central nervous system (CNS) effects of fentanyl.
  • Until your dose of fentanyl stabilizes, you may need another short-acting pain reliever for breakthrough pain.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Do not use heating pads, electric blankets, heated water beds, hot tubs, saunas, or heat lamps. These could cause fentanyl to be too rapidly absorbed, especially if devices slip onto the patch while you sleep.
  • You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay beside the chair until you are sure that you are not dizzy.
  • If nausea develops, try lying down until it subsides.
  • You may wear fentanyl patches while bathing, showering, or swimming, but do not rub the patch vigorously or stay for a prolonged time in hot water. If the patch loosens or dislodges, contact your doctor.
  • If you sleep or nap near someone else, cover the area of the patch with clothing. Otherwise, the patch could transfer to the other person. This has caused children to receive overdoses.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as possible, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Prepare the site with water. Do not shave the site or use soap, alcohol, or lotions. Do not apply to areas that are burned, cut, or irritated. Clip hair if necessary.
  • Remove liner just before using. Take care not to touch the adhesive surface. Wash with clean water any area the medication unintentionally touches.
  • Do not use if seal is broken or patch is otherwise damaged or cut.
  • Apply entire patch to dry skin above the waist. Press firmly with palm of hand for at least 30 seconds, especially around the edges.
  • If applying more than one patch, do not let edges overlap or touch.[12] Rotate site of application, preferably alternating sides of the body.
  • Change patch every three days, unless your doctor tells you to change at a different frequency.
  • Do not apply more than the prescribed dose.
  • Fold used patches in half with adhesive layer inside the fold. Flush down toilet or otherwise dispose of in secure manner.
  • Wash hands.
  • Do not stop using abruptly. A gradual reduction prevents withdrawal symptoms. Even if you stop using fentanyl patches, some of the drug can remain in older people for a few days.
  • Store at room temperature. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs are listed in the Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with this drug. We have also included potentially serious interactions listed in the drug’s FDA-approved professional product labeling or package insert. New scientific techniques have allowed researchers to predict some drug interactions before they have been documented in people. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. The number of new drugs approved for marketing increases the chance of drug interactions, and new drug interactions are being identified with old drugs. Be vigilant. Make sure to tell your doctor and pharmacist the drugs you are taking and tell your doctor if you are taking any of these interacting drugs:

People who take monoamine oxidase inhibitors should be off these drugs for 14 days before starting fentanyl.[13] These include: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.

Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics sedatives, sleeping pills, and tranquilizers. Doses of fentanyl and any of these drugs may need to be lowered by 50%. If any of these drugs are discontinued while you use fentanyl, adjustments in doses may be required.

Other drugs that can interact with fentanyl are: carbamazepine, DILANTIN, EES, erythromycin, ketoconazole, MERIDIA, naltrexone, NIZORAL, NORVIR, phenytoin, REVIA, RIFADIN, rifampin, ritonavir, sibutramine, TEGRETOL.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • abdominal swelling
  • difficulty breathing (If you care for a person who uses fentanyl patches and their breathing slows while sleeping, try to waken them. If breathing does not improve once awake, call their doctor.)[12]
  • fainting
  • problems speaking
  • chest pain
  • slow, fast, pounding, or irregular heartbeat
  • confusion
  • dizziness, incoordination, or fainting
  • fever with or without chills (your dose may be lowered temporarily)[12]
  • hallucinations
  • restlessness or nervousness
  • cold, red, swollen, or blistered skin with or without itching at patch
  • thickened or scaly skin
  • fluid-filled blisters
  • spitting blood
  • combative and/or suspicious thoughts
  • difficulty urinating (decreased frequency and/or volume)
  • mental or mood changes
  • unusual bruising
  • swollen glands
  • any change in vision
  • bladder pain

Call your doctor if these symptoms continue:

  • decreased appetite
  • anxiety, confusion
  • constipation
  • diarrhea
  • dizziness
  • unusual dreams
  • memory loss
  • drowsiness
  • dry mouth
  • headache
  • blurred vision
  • nausea or vomiting
  • red or itchy skin, sweating, tingling or burning sensation
  • weakness
  • abdominal or stomach pain
  • indigestion, gas
  • weight loss
  • sweating

Call your doctor if these symptoms continue after you stop taking this drug:

  • diarrhea
  • body aches
  • increased heartbeat
  • nervousness, restlessness, or irritability
  • nausea or vomiting
  • unusually enlarged pupils
  • shivering or trembling
  • increased sweating
  • fever, runny nose, or sneezing
  • stomach cramps
  • trouble sleeping
  • weakness
  • increased yawning
  • loss of appetite

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • blood pressure
  • heart rate
  • respiratory rate
  • degree of sedation

last reviewed February 29, 2024