Fentanyl nasal (for the nose) is an opioid medication used to treat "breakthrough" cancer pain. Fentanyl nasal is not for treating pain that isn't cancer-related, such as pain from surgery, dental work, or migraine headaches.

Fentanyl nasal is given with other non-fentanyl opioid pain medicine that is used around the clock.

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

Do not use fentanyl nasal to replace any other form of fentanyl. If you switch from another form of fentanyl, you will not use the same dose.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use fentanyl in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of fentanyl.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Never use fentanyl nasal together with a second form of fentanyl or to replace any other form of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).

If you switch to fentanyl nasal from another form of fentanyl, you will not use the same dose. You must start with the lowest dose.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if you still have pain more than 30 minutes after using the nasal spray, or if you have breakthrough pain more than 4 times in one day.

You must wait at least 2 hours after your last dose of fentanyl nasal before you can treat a new pain episode.

Do not stop using fentanyl suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature, away from heat and moisture. Keep this medicine out of the reach of children. The amount of fentanyl in each bottle of Lazanda can be fatal to a child.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion.

You should not use fentanyl if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

You should not use fentanyl nasal unless you already use a similar opioid medicine and your body is tolerant to it.

Do not give this medication to anyone under 18 years old.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, mental illness;

• urination problems;

• liver or kidney disease;

• a blockage in your stomach or intestines; or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breastfeed. Fentanyl can cause drowsiness, breathing problems, or withdrawal symptoms in a nursing infant.

Since fentanyl is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how fentanyl will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Fentanyl may cause serious side effects. Call your doctor at once if you have:

• slow heart rate, sighing, shallow breathing, breathing that stops during sleep;

• confusion, extreme fear, unusual thoughts or behavior;

• dizziness, feeling like you might pass out; or

• worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects of fentanyl may include:

• dizziness, drowsiness, weakness;

• anxiety, depression;

• trouble sleeping;

• stomach pain, nausea, vomiting, constipation; or

• swelling in your arms, hands, legs or feet.

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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may affect fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.