Generic Name: fentanyl (FEN-ta-nil)
Brand Name: Fentora

Fentora can be harmful or fatal if taken by children, patients for whom it has not been prescribed, or patients who are not tolerant to narcotic (opioid) pain medicine. Keep Fentora out of the reach of children.

Fentora is only for breakthrough pain caused by cancer in patients who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe and sometimes fatal breathing problems can occur in patients using Fentora, especially in patients not already using other narcotic medicines or patients taking certain other medicines. Ask your health care provider if Fentora may interact with other medicines that you take. Do not use Fentora for short-term pain (including headache, dental pain, or migraine) or for pain that occurs after surgery or injuries.

Do NOT take more than the recommended dose or use more often than prescribed. You must wait at least 4 hours after your last dose of Fentora before treating a NEW episode of breakthrough pain with Fentora.

Do not switch brands of Fentora without first talking with your doctor. Different brands may release different amounts of Fentora into your body. This may cause severe and possibly fatal overdose. Talk with your doctor or pharmacist for more information.


Fentora is used for:

Managing breakthrough pain in cancer patients who are already using and are tolerant to around-the-clock narcotic pain medicines.

Fentora is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use Fentora if:

  • you are allergic to any ingredient in Fentora or to any similar medicine (eg, sufentanil)
  • you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule
  • you have mild or short-term pain, including pain from injuries, surgery, dental pain, headache, or migraine
  • you are taking enzalutamide, mifepristone, sibutramine, or sodium oxybate (GHB)
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Fentora:

Some medical conditions may interact with Fentora. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mental or mood problems (eg, depression), hallucinations, or suicidal thoughts or actions
  • if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or have had a recent head injury
  • if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, heart problems (eg, slow or irregular heartbeat), liver or kidney disease, inflammation in the mouth, an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, low blood pressure, or seizures
  • if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence
  • if you have been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)
  • if you stop taking your around-the-clock narcotic pain medicine

Some MEDICINES MAY INTERACT with Fentora. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, fluconazole, ketoconazole), benzodiazepines (eg, diazepam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, cobicistat, crizotinib, macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), mifepristone, nefazodone, other opioid medicines (eg, oxycodone), perampanel, phenothiazines (eg, chlorpromazine), protease inhibitors (eg, boceprevir, ritonavir), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), telithromycin, or troleandomycin because they may increase the risk of Fentora's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness
  • Serotonin reuptake inhibitors (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur
  • Mixed agonist/antagonist analgesics (eg, buprenorphine, butorphanol, pentazocine), nalmefene, naloxone, or naltrexone because they may decrease Fentora's effectiveness and withdrawal symptoms may occur
  • Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, enzalutamide , modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease Fentora's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fentora may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fentora:

Use Fentora as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Fentora comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Fentora refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
  • Do not use Fentora if the blister pack is damaged in any way.
  • Do not chew, crush, suck, or swallow the tablet whole. Do not try to split the tablet in half.
  • Do not remove the tablet from the blister unit until you are ready to take Fentora. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister unit to expose the tablet. Take the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
  • Place the tablet between the upper cheek and gum above the back tooth, or place the tablet under the tongue. Leave the tablet in place and allow it to dissolve. Do not eat, drink, or smoke while the tablet is dissolving.
  • Fentora usually takes 14 to 25 minutes to dissolve. If any pieces of the tablet remain after 30 minutes, you may swallow them with a glass of water.
  • Place the tablet in the opposite side of your mouth the next time you use a dose.
  • If you notice that your medicine is a different color or shape, check with your pharmacist to make sure that you have the right medicine strength.
  • If your breakthrough pain does NOT get better within 30 minutes after your first dose, you may take a second dose as directed by your doctor. If your breakthrough pain does not get better after the second dose, contact your doctor. Do NOT take more than 2 doses per episode of breakthrough pain.
  • Wait at least 4 hours after your last dose of Fentora before treating a NEW episode of breakthrough pain. If you have more than 4 episodes of breakthrough pain per day, tell your doctor.
  • Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Fentora.
  • If Fentora is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Fentora properly.
  • Fentora is usually used as needed. If you forget to use a dose of Fentora and you still have pain, use it when you remember as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fentora.

Important safety information:

  • Fentora may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fentora with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Fentora.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fentora; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Fentora may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Constipation is a common side effect of Fentora. Talk with your doctor about using laxatives or stool softeners while you take Fentora to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.
  • Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Fentora without checking with your doctor.
  • Tell your doctor or dentist that you take Fentora before you receive any medical or dental care, emergency care, or surgery.
  • Contact your doctor if your pain is not relieved or if it worsens after you use Fentora. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Fentora so that your dose can be adjusted if needed.
  • Do not switch brands of Fentora without first talking to your doctor. Different brands may release different amounts of Fentora into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.
  • Use Fentora with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.
  • Fentora can be harmful, even fatal, if used in CHILDREN. Keep Fentora out of the reach of children.
  • Use Fentora with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Fentora may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fentora while you are pregnant. Fentora is found in breast milk. Do not breast-feed while taking Fentora.

When used for long periods of time or at high doses, Fentora may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Fentora stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Fentora. This is known as DEPENDENCE or "addiction."

If you suddenly stop taking Fentora, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Fentora:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; nausea; numbness, tingling, mild pain, or irritation at the site where the tablet is used; vomiting; weakness or tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); blurred vision or other vision problems; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; seizures; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness or headache; severe or persistent stomach pain; shortness of breath; slowed or shallow breathing; swelling of the arms, hands, legs, or feet; trouble sleeping; trouble urinating; unusual or severe weakness or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Proper storage of Fentora:

Store Fentora between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not use if the foil pouch has been opened. Keep Fentora out of the reach of children and away from pets.

General information:

  • If you have any questions about Fentora, please talk with your doctor, pharmacist, or other health care provider.
  • Fentora is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Fentora or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fentora. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fentora. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fentora.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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