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Important Safety Information
FENTORA can cause life-threatening breathing problems.
Do not use FENTORA unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant. Keep FENTORA in a safe place away from children. Read More Important Safety Information

Cancer can cause breakthrough pain1

For patients with cancer, experiencing pain throughout the day is common. This persistent pain can be controlled with daily around-the-clock (ATC) pain medications.1,2

However, relief can be disrupted by breakthrough pain (BTP) – intense “flares” of pain that “break through” ATC medications. Studies have shown that breakthrough pain is experienced by over half (51%-89%) of patients with cancer who take ATC medications daily to control persistent pain.1-3

Image showing breakthrough pain in cancer breaks through the cover of around-the-clock opioid medication

Breakthrough pain has unique characteristics that make it different from persistent cancer pain2-4

  • Comes on rapidly
  • It is often unpredictable
  • Usually lasts only for a short period of time
  • Can happen several times a day
Breakthrough pain requires a specific management therapy5

Let's build a

A discussion guide is a good way to start a conversation
with your doctor about your breakthrough cancer pain.

Fill in your answers to these 7 questions, print your results,
and bring them on your next doctor's visit. If you prefer,
you can email the answers to yourself.

Question 1 of 7
I've been taking my opioids around-the-clock and I'm still having pain.
Question 2 of 7
My most recent breakthrough pain episode occurred on:
Select Today
Select a Date
Question 3 of 7
I experienced breakthrough pain on
day(s) within the last 2 weeks.
Question 4 of 7
On a scale of 0 to 10 (0 being "no pain" and 10 being "worst pain I ever felt")
I gave my most recent pain episode a _______ rating.
Question 5 of 7
The pain felt like (type in a description of how your pain felt,
or choose from one of the examples):
Description must not exceed 500 characters.
Question 6 of 7
I took the prescribed dose of the medication
Medication name must not exceed 500 characters.
Set Time
Question 7 of 7
30 minutes after taking the dose of medication, I gave this pain a ____ rating
(0 being "no pain" and 10 being "worst pain I ever felt").
Your custom discussion guide has been created.



Do not use FENTORA® (fentanyl buccal tablet) CII unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep FENTORA in a safe place away from children.

Get emergency help right away if:

  • a child takes FENTORA. FENTORA can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed FENTORA uses it.
  • an adult who is not already taking opioids around-the-clock, uses FENTORA.

These are medical emergencies that can cause death. If possible, try to remove FENTORA from the mouth.

Important information about FENTORA:

  • Get emergency help right away if you take too much FENTORA (overdose). When you first start taking FENTORA, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur.
  • Taking FENTORA with other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
  • Never give anyone else your FENTORA. They could die from taking it. Store FENTORA away from children and in a safe place to prevent stealing or abuse. Selling or giving away FENTORA is against the law.
  • If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using FENTORA. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  • FENTORA is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive FENTORA, you must:
    • - talk to your healthcare provider
    • - understand the benefits and risks of FENTORA
    • - agree to all of the instructions
    • - sign the Patient-Prescriber Agreement form
  • FENTORA is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your FENTORA prescription filled.
  • Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not take FENTORA if:

  • You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines.
  • You have severe asthma, trouble breathing, or other lung problems.
  • You have a bowel blockage or have narrowing of the stomach or intestines.
  • You are allergic to any of the ingredients in FENTORA. See the Medication Guide for a complete list of ingredients in FENTORA.
  • You have short-term pain that you would expect to go away in a few days, such as: pain after surgery, headache or migraine, dental pain

Before taking FENTORA, tell your healthcare provider if you have a history of: troubled breathing or lung problems such as asthma, wheezing, or shortness of breath; head injury, seizures; slow heart rate or other heart problems; low blood pressure; mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)]; problems urinating; liver, kidney, thyroid problems; pancreas or gallbladder problems; abuse of street or prescription drugs, alcohol addiction, or mental health problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of FENTORA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. FENTORA passes into breast milk and may harm your baby.
  • taking prescription over-the-counter medicines, vitamins, or herbal supplements. Taking FENTORA with certain other medicines can cause serious side effects that could lead to death.

When taking FENTORA:

  • DO NOT Drive or operate heavy machinery, until you know how FENTORA affects you. FENTORA can make you sleepy, dizzy, or lightheaded.
  • DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with FENTORA may cause you to overdose and die.
  • DO NOT Switch from FENTORA to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of FENTORA is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of FENTORA that may be different than other fentanyl containing medicines you may have been taking.

Possible side effects of FENTORA:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, low red blood cell count, swelling of the arms, hands, legs and feet. Call your healthcare provider if you have any of these symptoms and they are severe.
  • decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  • pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • These symptoms can be a sign that you have taken too much FENTORA or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more FENTORA until you have talked to your healthcare provider.

These are not all the possible side effects of FENTORA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to

Please read the Medication Guide located at the end of the Full Prescribing Information for FENTORA.

References: 1. Weinstein SM, Messina J, Xie F. Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: a long-term, open-label safety study. Cancer. 2009;115(11):2571-2579. 2. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273-281. 3. Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage. 2000;20(2):87-92. 4. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81(1-2):129-134. 5. Portenoy RK, Taylor D, Messina J, Tremmel L. A randomized placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. Clin J Pain. 2006;22(9):805-811. 6. Fentora [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2016.
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FENTORA Patient Brochure and Journal
Download a brochure to keep track of your breakthrough cancer pain and learn about treatment with FENTORA.
FENTORA provides relief that generally matches the pattern
of breakthrough pain in opioid-tolerant adults with cancer.5,6
FENTORA is an oral tablet placed inside your mouth to dissolve.6