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Fentanyl Transdermal System

(fent-uh-nil)

Trade/other name(s): Duragesic, fentanyl film, fentanyl patch

Why would this drug be used?

Fentanyl transdermal is a strong pain medicine (an opioid analgesic) that comes in a patch. It is used to treat long-term moderate to severe pain. It is only used in people who need continuous pain relief. Before starting fentanyl patches, the person must have already gotten used to taking opioid pain medicines such as morphine, hydromorphone, or oxycodone, and have taken them every day for at least a week before starting fentanyl.

(Note that there is also a gel patch known as Ionsys, a special fentanyl formula used for short-term pain relief after surgery. The information here does not apply to Ionsys.)

How does this drug work?

Fentanyl transdermal system is an opioid pain reliever. It binds to opioid receptors in the brain and central nervous system, reducing the perception of pain as well as the emotional response to pain.

The fentanyl patch is stuck onto the skin, and usually left there for 3 days. The drug is gradually absorbed through the layers of skin over that time. When it is removed, a new patch is applied to a different area of skin.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods, or any types of glue or adhesive.
  • Exactly how much of which pain medicines you have been taking, and how much they relieved your pain. This will help the doctor decide what starting dose of fentanyl you should get.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), low thyroid function, or Addison’s disease (low adrenal function). These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you have abdominal pain or any disorder with slowed or blocked intestines, such as paralytic ileus, you shouldn’t take fentanyl. If you’ve had this kind of problem in the past, tell your doctor so that you can be watched in case it comes back.
  • If you have trouble passing urine, a narrow urethra, or if you have an enlarged prostate. Fentanyl can make it harder to urinate.
  • If you have ever had a seizure, head injury, or if you have had problems with pressure, infection, or a tumor in your head or brain. Fentanyl can raise your risk of seizures.
  • If you have ever been told you have a slow heart rate (bradycardia) or an abnormal heart rhythm. Fentanyl can slow the heart rate in some people. Your doctor might need to watch you more closely.
  • If you have low blood pressure. Fentanyl can worsen this.
  • If you have asthma, emphysema, chronic bronchitis, sleep apnea, or another breathing problem. Fentanyl can make it worse, and even cause death by stopping your breathing.
  • If you have gallstones, gallbladder disease, or pancreatitis. Fentanyl can sometimes worsen these problems.
  • If you have taken monoamine oxidase inhibitors (MAOIs) within the past 2 weeks (see “Interactions with other drugs”). Fentanyl can cause slow or shallow breathing, low blood pressure, excitability, seizures, coma, or shock if any MAOI is left in the body.
  • If you are planning to have surgery or anything requiring general anesthesia in the near future. (See also “Precautions.”)
  • If you drink alcohol or take any medicine that can affect your brain or nervous system. These may worsen the side effects of fentanyl or cause other problems.
  • If you have serious mental illness or if you have ever had delirium tremens (severe alcohol withdrawal symptoms). You may have more problems on fentanyl.
  • If you have trouble with addiction, alcohol, or drug abuse now or have had problems with any of these in the past. Fentanyl can be habit forming, especially for those who have had problems before.
  • If any family members have or have had an addiction or drug problem. Fentanyl is sometimes stolen by or for those who have become addicted to it or drugs like it.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. There may be an increased risk of harm to the fetus if a woman takes this drug during pregnancy, especially later in pregnancy (see “Precautions” section).
  • If you are breastfeeding. The drug passes into breast milk and can harm the baby.
  • About all other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

The following drugs can cause fentanyl to build up in the body, raising the risk of serious side effects or even overdose. If you need one of these medicines while you are taking fentanyl, your doctor may be able to adjust your fentanyl dose:

  • Antidepressant drugs such as nefazodone (Serzone), fluvoxamine (Luvox), and fluoxetine (Prozac, Serafem)
  • Antibiotics such as erythromycin (E.E.S., E-Mycin, Erythrocin), clarithromycin (Biaxin), and norfloxacin (Noroxin)
  • Anti-fungals such as ketoconazole (Nizoral), itraconazole (Sporanox), and voriconazole (Vfend)
  • The anti-nausea drug aprepitant (Emend)
  • Certain blood pressure medicines such as diltiazem and verapamil
  • HIV drugs such as indinavir, ritonavir, amprenavir, fosamprenavir, and nelfinavir

Do not start or stop these medicines while on fentanyl without talking with the prescribing doctor(s) about all of the medicines you take, including fentanyl.

Antidepressants of the older monoamine oxidase inhibitor (MAOI) type such as phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan), or selegiline (Emsam) may cause slow or shallow breathing, low blood pressure, excitability, seizures, shock, or even coma if fentanyl is given within 2 weeks of the last MAOI dose.

Medicines or substances that slow down the brain or nervous system, such as these, can cause worse side effects if taken with fentanyl:

  • Anti-anxiety drugs (tranquilizers or sedatives)
  • Sleeping pills
  • Muscle relaxers
  • Barbiturates
  • Anti-seizure medicines
  • Other opioid drugs
  • Anesthetics
  • Tricyclic antidepressants such as amitriptyline (Elavil), nortriptyline (Pamelor), imipramine (Tofranil), desipramine (Norpramin), doxepin (Sinequan), and others
  • Anti-psychotic drugs
  • Certain anti-nausea medicines
  • Certain antihistamines (those that cause sleepiness)
  • Alcohol-containing drugs or beverages, including beer, wine, and mixed drinks

Some of these drugs can cause slowed breathing, low blood pressure, extreme sleepiness, coma, or even death if taken with fentanyl.

Naltrexone will keep fentanyl from working or stop it from working.

Buprenorphine (Subutex, Suboxone), butorphanol (Stadol), nalbuphine (Nubain), or pentazocine (Talwin, Talacen) may decrease the effects of fentanyl or stop its action altogether. This can cause withdrawal symptoms if you have used fentanyl for some time.

Some medicines, such as the anti-seizure drugs carbamazepine and phenytoin, can make the body get rid of fentanyl faster, as can the TB drugs rifampin and rifabutin, and the herb St. John’s wort. They can make fentanyl less effective in controlling pain, although doses can be adjusted if you are taking the medicines regularly. If you are on one of these medicines when you start taking fentanyl, talk to your doctor before you stop them. You may need less fentanyl after you stop the drug.

Check with your doctor, nurse, or pharmacist about whether other medicines, vitamins, herbs, and supplements can cause problems with this medicine.

Do not start or stop any medicines while on fentanyl without talking with the prescribing doctor(s) about all of the medicines you take, including fentanyl.

Interactions with foods

Certain foods, such as grapefruit or grapefruit juice, may raise the level of this drug in your body. This can worsen any bad effects the drug may have on you.

Beverages that contain alcohol, including beer, wine, and mixed drinks, can raise the risk of harmful effects and death if taken while you’re being treated with fentanyl.

Check with your doctor, nurse, or pharmacist about whether other foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Fentanyl transdermal system is a patch that contains medicine in gel form inside it. When you first start the patch, or when the dose is changed, it can take 12 to 24 hours for the drug to provide pain relief. It may take 3 to 6 days for the drug to reach a stable level in the body so that you and your doctor are able to gauge its effects. You may need to take another pain medicine at first, until the fentanyl reaches a level that works for your pain.

First, decide on a good place on your body to put the patch. The area should be clean, flat, and without any injuries, sores, or bumps. Avoid skin that is irritated, cut, or has been radiated. You may clip any hair at the site with scissors, but do not shave it. Avoid sites where the skin bends or wrinkles a lot. On the chest below the collar bones, on your back, on the side of your waist (flank), or on the upper arms are the best sites to apply the patch. If skin needs to be cleaned, use clear water only and allow the skin to dry completely before putting on the patch. Do not use soap, oil, lotion, or alcohol on the skin before putting on the patch.

Open the package just before you plan to use it. Do not use the patch if the seal was broken on the package, or if the patch is torn or damaged in any way. Never cut or tear the fentanyl patch. Handle the patch by its edges and carefully remove the protective liner.

To help keep track of your doses, write the date and time on the white sticker that comes with the patch. Press the sticky side of the patch firmly to the skin, and keep the palm of your hand pressed on the patch for at least 30 seconds. Be sure that all the edges stick to your skin. To make sure the patch stays in place, some people like to tape the edges of the patch to the skin with paper tape or put a clear film dressing over it. Never cover a patch with any other bandage or tape. If you have trouble keeping the patch in place, ask your nurse or doctor about the best way to handle this.

Never put a heating pad or any other heat source near the patch. Heat can make the medicine absorb faster, and cause a serious or fatal overdose. Changing the patch too often or using more patches than prescribed can also cause an overdose. You can shower, bathe, or swim in cool water or warm water while wearing your patch.

The patch should be left on for 3 days (72 hours). Try to change the patch at about the same time of the day each time. If it falls off before 72 hours has passed, discard it carefully (as described below) and put a new one on at a different site, then wait 72 hours after you put it on to replace it again. Be sure to tell your doctor this happened.

Always take off the old patch before putting on a new one. To remove it, gently pull it off the skin. Fold the sticky side of the patch in half back on itself. Flush the used patch down the toilet to get rid of any drug left in it. Do not throw it into the trash where a child, pet, or another person might find it or accidentally come in contact with it.

Select a different site for a new fentanyl patch and apply it as noted above. Wash your hands after touching new or used patches.

Call your doctor or nurse if you have skin problems where you apply the patch. They will help you find ways to prevent this.

Never use more than one patch at a time unless your doctor tells you to.

The starting dose depends on how much opioid medicine you needed before to control your pain. Keep your doctor or nurse informed about how well it relieves your pain. The right dose is the dose that controls your pain.

Take this drug exactly as directed by your doctor; if you do not understand these instructions, ask your doctor or nurse to explain them to you.

Keep the box of unopened patches in a safe place, protected from theft or misuse, and out of the reach of children, pets, and other people. Deaths have occurred when children or pets have gotten fentanyl patches, or when they were used by others.

Precautions

If you have never taken opioid pain relievers before, be sure your doctor or nurse knows that before you start using fentanyl. Only people who have taken opioid pain medicines regularly and recently should use fentanyl patches. It is important that your doctor know exactly what medicines you were taking before starting fentanyl. Keep a record of the names of pain relievers you are taking and how often you take them so that you can show it to your doctor or nurse. This will help your doctor choose the best dose of fentanyl for you.

This drug is not intended for “as needed” use or for short term pain. Talk to your doctor or nurse if you have questions about this.

Always talk with your doctor before starting or stopping any medicines while on fentanyl. Because some drugs cause fentanyl to build up in the body, you can get too much fentanyl and have serious side effects or even overdose. Other drugs can cause fentanyl to leave the body faster so that your pain is not controlled.

This medicine can cause drowsiness and lightheadedness. Do not drive, operate machinery, or perform other activities that require alertness until you know how you react to this medicine.

Fentanyl can make you feel dizzy or faint, and increase your risk of falling. Be careful getting up, changing position, or walking. Get up slowly and hold onto something or someone to keep you steady. If you feel lightheaded or dizzy, it may help to lie down. It is best to have a responsible adult with you for the first few days after starting the fentanyl or after any increase in dose, until you know how you will respond to it.

Do not expose your skin to heat sources such as heat or tanning lamps, heating pads, electric blankets, saunas, hot tubs, heated water beds, or other warming devices while the patch is on it. Avoid long, hot baths or sunbathing. Heating the patch can cause your body to absorb the drug more quickly and cause an accidental overdose.

Fever can also cause the body to absorb more fentanyl through the skin. If you have a fever, call your doctor or nurse for instructions. Your dose may need to be reduced until your fever goes down. Physical exertion can raise the skin temperature and cause more fentanyl to be absorbed.

Since fentanyl affects the central nervous system, it is important not to take other drugs or substances that slow down the brain or nervous system such as alcohol, sedatives, muscle relaxers, and sleeping medicines unless your doctor tells you to do so (see “Interactions with other drugs”).

Call your doctor right away if you have trouble breathing, get short of breath, dizzy, faint, get confused, feel very drowsy, or start seeing or hearing things that aren't there. These may be signs your dose is too high, or you could have gotten an accidental overdose of the medicine.

Tell your doctor or nurse right away if you have trouble passing urine, walking, vision problems, fainting, trouble swallowing, or other problems.

If you are having any kind of surgery or medical procedure, be sure to tell the doctor or dentist in charge that you are using this medicine. Some anesthetic drugs can cause a dangerous drop in blood pressure if fentanyl is in your system. You will also need to take off the patch before getting an MRI (magnetic resonance imaging) test to avoid skin burns.

Constipation is a very common side effect of taking opioid pain medicines. While you’re taking fentanyl, your doctor may advise you to take medicines such as stool softeners, bulk-forming agents, and/or laxatives as needed to have regular (daily) bowel movements. Talk to your nurse or doctor about this when you first start this medicine. Drink plenty of fluids throughout the day, and try to eat foods high in fiber such as whole grains, bran, fruits, and vegetables. Call your doctor or nurse right away if you have not moved your bowels in 2 days.

Acetaminophen or aspirin are often used with fentanyl transdermal system to increase the pain relief action. It is important to know if any of your other medicines contain either of these drugs. Because they are in many other prescription and non-prescription drugs, it is easy to accidentally get too much of them. Check with your doctor, nurse, or pharmacist to find out which of these drugs are included in your daily medicines, and how much more, if any, you can safely take.

Most cancer pain can be controlled. Tell your cancer team if your medicines do not control your pain, and keep them informed about any side effects you are having. Your doctor may need to adjust your medicines several times before they find the medicines that work best for you. When the patch is used, it can take a day or so before the drug begins to act, and 3 or more days to find out if the fentanyl dose will work for you.

Even if you feel the medicine is not working, do not increase the amount of fentanyl. If you’ve just started using fentanyl patches, it will take 3 to 6 days for the drug to reach its full effect. Call your doctor or nurse to find out if you can take a different pain medicine. Most people need short-acting pain medicines to control their pain for the first few days until the fentanyl gets to its full effect and the dose is figured out.

If your pain comes back while the patch is in place, talk to your doctor about changing your medicine or adding a short-acting drug to take for “breakthrough” pain not controlled by the fentanyl. If an extra medicine is prescribed for this purpose, don’t wait until the pain is bad before you take it. If pain is allowed to worsen, it takes more medicine to get it under control. However, do not take more of the “breakthrough” medicine or take it more often than the doctor directs. If you do, it could increase your chance of overdose and serious side effects.

Talk to your doctor or nurse about using the smallest effective dose to reduce side effects. Tolerance (when larger doses are needed to give the same effect) and physical dependence (when the body goes into withdrawal if drug is suddenly stopped) happen normally when strong opioid medicines are taken over several weeks to treat chronic pain. But this is different from addiction, which starts when the drug is taken for pleasure rather than for relief of pain. Tell your doctor or nurse if you still have pain even though you are taking fentanyl as directed. Do not adjust your dose without talking to your doctor or nurse.

Do not stop taking this medicine without talking to your doctor or nurse. When no longer needed, your dose should be gradually reduced with the help of your doctor. If it is stopped quickly, withdrawal symptoms may occur, such as restlessness, irritability, anxiety, runny nose, watering eyes, yawning, sweating, chills, gooseflesh, aches, nausea, vomiting, diarrhea, poor appetite, high blood pressure, fast heartbeat, and fast breathing. Note that some fentanyl remains in the skin after the patch is removed and that it will still be absorbed from the skin for several hours after the patch is removed.

Using opioid drugs such as fentanyl during pregnancy, especially near the end of the pregnancy, can cause neonatal opioid withdrawal. This can be life-threatening to a newborn if it’s not recognized and treated.

This drug is a controlled substance, and may be habit forming. Keep your medicine in a safe place, away from other people, and do not let anyone else take it. Fentanyl has caused deaths in people who were not accustomed to taking opioids, and death happened faster in those who put the patch in their mouths or tried to extract all the medicine at once. A person who has taken opioid medicines for a long time often needs large doses for pain relief, while the same amount could quickly kill someone else.

If children or others accidentally get the patch on their bodies, remove it as quickly as possible and flush the area with plenty of clear water while calling for emergency help. Using alcohol or soap may allow more of the medicine to absorb through the skin.

If you think you or someone else may have taken an overdose of fentanyl, or if someone else has applied even one patch, get emergency help right away. Symptoms of an overdose may take some time to appear, so do not wait. Symptoms of fentanyl overdose may include extreme drowsiness, slow heartbeat, slow or irregular breathing, cold clammy skin, or coma. Fentanyl overdose can cause the heart or breathing to stop. Because it can take up to a day for all medicine to absorb from the skin layers after the patch is removed, the person may need to be observed for some time after getting the drug.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Sleepiness
  • Constipation*
  • Dizziness*
  • Nausea
  • Vomiting

Less Common

  • Slow or shallow breathing, or trouble breathing*
  • Confusion*
  • Tremors
  • Mood changes, such as euphoria (happiness), depression, or irritability
  • Low blood pressure, which can cause dizziness when sitting up or standing*
  • Trouble urinating*
  • Lack of coordination
  • Trouble speaking
  • Chest pain
  • Abdominal (belly) pain
  • Sweating
  • Rash (usually under skin patch)
  • Itching
  • Headache

Rare

  • Blood-tinged sputum
  • Hiccups
  • Hallucinations (seeing or hearing things that aren’t there)*
  • Sore throat
  • Trouble walking*
  • Urinary urgency
  • Slowed heart rate
  • Opioid withdrawal and even death in the newborn if it’s taken during pregnancy*
  • Death due to accidental exposure, misuse, or even when used as prescribed*

*See “Precautions” section for more detailed information.

There are some other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1990

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 06/18/2014
Last Revised: 06/18/2014