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Fentanyl has a risk for abuse and addiction, which can lead to overdose and death. Fentanyl may also cause severe, possibly fatal, breathing problems. Do not use fentanyl lozenges unless you have been regularly taking moderate to large amounts of opioid pain medication. Otherwise, it may cause overdose (even death). To lower your risk, your doctor should have you use the smallest dose of fentanyl that works, and use it for the shortest possible time. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you use the wrong dose/strength. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to use fentanyl and what other drugs you should avoid using with it. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Carefully follow the specific directions for using fentanyl lozenges. Since they are not taken the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works. Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval. Keep this medicine in a safe place to prevent theft, misuse, or abuse. Properly throw away all opened units of this drug. If someone accidentally swallows this drug, get medical help right away. To receive fentanyl in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Pain, sores, or irritation in the mouth (where the medication has been applied) may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss). Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, severe drowsiness/difficulty waking up. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan. Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include azole antifungals (such as itraconazole, ketoconazole), calcium channel blockers (such as diltiazem, verapamil), HIV protease inhibitors (such as nelfinavir), macrolide antibiotics (such as erythromycin), mifepristone, nefazodone, rifamycins (such as rifabutin), ritonavir, certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Some examples are street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (such as SSRIs like fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. This medication may interfere with certain lab tests (such as amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.