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fentanyl (buccal)

Pronunciation: FEN ta nil (BUK al)

Brand: Fentora, Onsolis

What is the most important information I should know about fentanyl buccal?

Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

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Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Fentanyl buccal tablets are used to treat "breakthrough" cancer pain. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

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Do not use fentanyl buccal if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using fentanyl buccal, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.

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Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

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Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What is fentanyl buccal?

Fentanyl is a narcotic (opioid) pain medicine.

Fentanyl buccal is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl buccal is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Fentanyl buccal may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using fentanyl buccal?

Multum donot

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, and others), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.

Multum donot

Do not use fentanyl if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take fentanyl buccal, tell your doctor if you have any of these other conditions:

  • a breathing disorder such as chronic obstructive pulmonary disease (COPD);
  • a history of head injury or brain tumor;
  • a heart rhythm disorder;
  • seizures or epilepsy;
  • mental illness such as depression, hallucinations;
  • low blood pressure;
  • liver or kidney disease; or
  • a history of drug or alcohol addiction.
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Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl buccal with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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FDA pregnancy category C. It is not known whether fentanyl buccal will harm an unborn baby. Fentanyl may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl buccal.

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Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while you are using fentanyl buccal.

How should I use fentanyl buccal?

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Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Use exactly as prescribed. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets), you will not use the same fentanyl dose. Fentora is given at lower doses than Actiq. Using too much Fentora can cause a fatal overdose.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use only dry fingers when handling fentanyl buccal tablets or film. Use only 1 tablet or film at a time. Do not swallow the tablet or film whole. Allow the medicine to dissolve in your mouth without breaking, chewing, or sucking on it.

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If you feel dizzy, nauseated, or very sleepy while the tablet is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the tablet. Call your doctor for instructions.

If your pain does not completely go away, use a second tablet or film only if your doctor has approved it.

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Wait at least 2 hours to treat a new pain episode with fentanyl buccal film. Wait at least 4 hours to treat a new pain episode with fentanyl buccal tablets.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.

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Do not stop using fentanyl buccal suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl.

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Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

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Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine its original package until you are ready to take your dose.

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Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not use a fentanyl buccal tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet down a toilet. Throw away any other unused tablets or by removing them from the blister pack and flushing them down a toilet.

Throw away unused film by removing them from the blister pack and flushing them down a toilet.

What happens if I miss a dose?

Since fentanyl buccal is used on an as needed basis, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.

Overdose symptoms may include extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, weak pulse, fainting, slow breathing (breathing may stop).

What should I avoid while using fentanyl buccal?

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Do not use fentanyl with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

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This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you.

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Do not drink alcohol. It can increase drowsiness or breathing problems caused by fentanyl.

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of fentanyl buccal?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness;
  • headache;
  • feeling weak or tired;
  • swelling in your hands or feet; or
  • pain or mouth sores where the medicine was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fentanyl buccal?

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Do not take fentanyl buccal with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • St. John's wort;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);
  • antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with fentanyl buccal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fentanyl buccal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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