"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(Generic versions may still be available.)
Ionsys Patient Information Including Side Effects
Brand Names: Ionsys
Generic Name: fentanyl transdermal (device) (Pronunciation: FEN ta nil trans DERM al)
- What is fentanyl transdermal (Ionsys)?
- What are the possible side effects of fentanyl transdermal (Ionsys)?
- What is the most important information I should know about a fentanyl transdermal device (Ionsys)?
- What should I discuss with my healthcare provider before using a fentanyl transdermal device (Ionsys)?
- How is a fentanyl transdermal device used (Ionsys)?
- What happens if I miss a dose (Ionsys)?
- What happens if I overdose (Ionsys)?
- What should I avoid while using a fentanyl transdermal device (Ionsys)?
- What other drugs will affect fentanyl transdermal (Ionsys)?
- Where can I get more information?
What is fentanyl transdermal (Ionsys)?
Fentanyl is a narcotic (opioid) pain medicine.
The fentanyl transdermal device is used only in a hospital to treat acute pain after surgery.
Fentanyl transdermal may be used for other purposes not listed in this medication guide.
What are the possible side effects of fentanyl transdermal (Ionsys)?
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.
Tell your caregivers right away if you have any of these serious side effects:
- weak, shallow breathing;
- severe weakness, feeling light-headed or fainting;
- cold, clammy skin; or
- pale skin, easy bruising or bleeding.
Less serious side effects may include:
- nausea, vomiting, stomach pain, constipation, gas;
- dizziness, drowsiness, anxiety, sleep problems (insomnia);
- muscle stiffness, back pain;
- itching, blistering, redness, or swelling where the patch or device was worn; or
- increased sweating, urinating less than usual.
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 Ionsys (fentanyl iontophoretic transdermal system) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about a fentanyl transdermal device (Ionsys)?
The fentanyl transdermal device is used only while you are in a hospital. You will not be allowed to use the device at home. Do not leave the hospital with a device on your skin.
Fentanyl may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction.
Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.
The fentanyl transdermal device may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the device before undergoing such a test.
Additional Ionsys Information
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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