About FENTORA

Side Effects of FENTORA

All medicines have benefits and risks. Some of FENTORA’s side effects are common to all opioids, and some may be life threatening and require immediate medical attention. It is important to know the signs of any FENTORA side effects.

When You Need Emergency Help

FENTORA can cause serious breathing problems, including slow, shallow breathing that can become life threatening, especially if FENTORA is used the wrong way.

Call your healthcare professional, or get emergency medical help right away, if you or the person taking the medication is:

  • Having trouble breathing
  • Having extreme drowsiness, with slowed breathing
  • Having slow, shallow breathing (little chest movement while breathing)
  • Feeling faint, very dizzy, confused, or have unusual symptoms

The above symptoms mean you have taken too much (overdose) 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 experience these symptoms, call 911 or emergency help immediately.

Common Side Effects

The most common side effects of FENTORA are nausea, vomiting, dizziness, sleepiness, headache, and constipation. These are not all the possible side effects of FENTORA. For a complete list, ask your healthcare professional.

Constipation (hard or infrequent bowel movements) is a very common side effect of opioid pain medicines and may happen with FENTORA. Constipation is unlikely to go away without treatment. Talk with your healthcare professional about changes in your diet and the use of laxatives and stool softeners to prevent or treat constipation while taking FENTORA.

  • FENTORA can cause pain or sores at the application site (on your gum or inside your cheek). Tell your healthcare professional if this is a problem for you.
  • FENTORA can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.
  • FENTORA can cause physical dependence. Do not stop taking FENTORA or any other opioid without talking to your healthcare professional. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
  • There is a chance of abuse or addiction with FENTORA. The chance is higher if you are or have been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental health issues.

These are not all the possible side effects of FENTORA. For a complete list, ask your healthcare professional.

Call your healthcare professional for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

IMPORTANT:

Do not use FENTORA unless you are regularly using another opioid pain medicine around-the-clock 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.

Read this Medication Guide completely before you start using FENTORA, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Share this important information with members of your household and other caregivers.

FENTORA is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.

The most important information you should know about FENTORA is:

FENTORA can cause life-threatening breathing problems which can lead to death.

  1. Do not use FENTORA if you are not opioid tolerant.
  2. 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.
  3. Use FENTORA exactly as prescribed by your healthcare provider.
    • You must not use more than 2 doses of FENTORA for each episode of breakthrough cancer pain.
    • You must wait at least 4 hours before treating a new episode of breakthrough pain with FENTORA. See the Medication Guide section “How should I use FENTORA?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to use FENTORA the right way.
  4. 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.