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Actiq Patient Information Including Side Effects

Brand Names: Actiq

Generic Name: fentanyl citrate (oral transmucosal) (Pronunciation: FEN ta nil SIT rayt)

What is fentanyl citrate (Actiq)?

Fentanyl citrate is an opioid pain medication. An opioid is sometimes called a narcotic.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as migraine headaches or pain after surgery.

Fentanyl citrate is available only under a special program called Actiq REMS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

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

What are the possible side effects of fentanyl citrate (Actiq)?

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 citrate and call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing, slow heart rate;
  • extreme sleepiness; or
  • feeling like you might pass out.

Less serious side effects may include:

  • dry mouth;
  • headache, dizziness, weakness, anxiety; or
  • nausea, vomiting, or constipation.

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.

Read the Actiq (fentanyl citrate) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about fentanyl citrate (Actiq)?

You should not use this medication 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.

Do not use fentanyl citrate 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.

Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Fentanyl citrate may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Do not use more than four Actiq units per day.

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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