Medications and Drugs

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Brand Names: Fentora, Onsolis

Generic Name: fentanyl (buccal) (Pronunciation: FEN ta nil (BUK al))

• What is fentanyl buccal (Fentora, Onsolis)?
• What are the possible side effects of fentanyl buccal (Fentora, Onsolis)?
• What is the most important information I should know about fentanyl buccal (Fentora, Onsolis)?
• What should I discuss with my healthcare provider before using fentanyl buccal (Fentora, Onsolis)?
• How should I use fentanyl buccal (Fentora, Onsolis)?
• What happens if I miss a dose (Fentora, Onsolis)?
• What happens if I overdose (Fentora, Onsolis)?
• What should I avoid while using fentanyl buccal (Fentora, Onsolis)?
• What other drugs will affect fentanyl buccal (Fentora, Onsolis)?
• Where can I get more information?

What is fentanyl buccal (Fentora, Onsolis)?

Fentanyl is a narcotic (opioid) pain medicine.

Fentanyl buccal tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines. 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 other purposes not listed in this medication guide.

What are the possible side effects of fentanyl buccal (Fentora, Onsolis)?

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.

Stop using fentanyl buccal and call your doctor at once if you have any of these serious side effects:

• weak, shallow breathing;
• severe weakness, drowsiness, or confusion;
• cold, clammy skin; or
• feeling light-headed or fainting.

Less serious side effects may include:

• nausea, vomiting, stomach pain, constipation;
• dizziness, drowsiness, headache;
• swelling; or
• pain or mouth sores where the tablet 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 is the most important information I should know about fentanyl buccal (Fentora, Onsolis)?

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 that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Do not use fentanyl if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 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.

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.

Fentanyl buccal may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.