Generic name: Fentanyl Sublingual Spray (FEN ta nil)
Brand name: Subsys
Drug class: Narcotic analgesics
Medically reviewed by Drugs.com. Last updated on Oct 9, 2020.
- This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
- The chance of very bad and sometimes deadly breathing problems may be greater when you first start fentanyl sublingual spray or anytime your dose is raised.
- Even one dose of fentanyl sublingual spray may be deadly if it is taken by someone else or by accident, especially in children. If fentanyl sublingual spray is taken by someone else or by accident, get medical help right away.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of fentanyl sublingual spray can lead to overdose and death. Talk with your doctor.
- You will be watched closely to make sure you do not misuse, abuse, or become addicted to fentanyl sublingual spray.
- This medicine has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor.
- Many drugs interact with fentanyl sublingual spray and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use fentanyl sublingual spray with all of your drugs.
- Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
- Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.
- Using fentanyl sublingual spray for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
Uses of Fentanyl Sublingual Spray:
- It is used to ease pain.
- This medicine is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).
- This medicine is only for use by people who have been taking pain drugs (opioids) and are used to their effects. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Fentanyl Sublingual Spray?
- If you are allergic to fentanyl sublingual spray; any part of fentanyl sublingual spray; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
- If you have any of these health problems: Kidney disease or liver disease.
- If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
- If you are taking any of these drugs: Linezolid or methylene blue.
- If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
- If have sores in your mouth, talk with your doctor.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with fentanyl sublingual spray.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take fentanyl sublingual spray with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Fentanyl Sublingual Spray?
- Tell all of your health care providers that you take fentanyl sublingual spray. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how fentanyl sublingual spray affects you.
- To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
- Long-term or regular use of opioid drugs like fentanyl sublingual spray may lead to dependence. Lowering the dose or stopping fentanyl sublingual spray all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop fentanyl sublingual spray. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- Do not take fentanyl sublingual spray with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
- If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
- This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking fentanyl sublingual spray.
- Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
- If you are 65 or older, use fentanyl sublingual spray with care. You could have more side effects.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking fentanyl sublingual spray, call your doctor right away.
How is this medicine (Fentanyl Sublingual Spray) best taken?
Use fentanyl sublingual spray as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Spray into the mouth under the tongue.
What do I do if I miss a dose?
- If you use fentanyl sublingual spray on a regular basis, use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses at the same time or extra doses.
- Many times fentanyl sublingual spray is taken on an as needed basis. Do not take more often than told by the doctor.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Feeling confused.
- Severe constipation or stomach pain. These may be signs of a severe bowel problem.
- Noisy breathing.
- Chest pain.
- Fast or slow heartbeat.
- Low mood (depression).
- Trouble controlling body movements.
- Swelling in the arms or legs.
- A severe and sometimes deadly problem called serotonin syndrome may happen if you take fentanyl sublingual spray with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
- Taking an opioid drug like fentanyl sublingual spray may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
What are some other side effects of Fentanyl Sublingual Spray?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling dizzy, sleepy, tired, or weak.
- Dry mouth.
- Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
- Feeling cold.
- Trouble sleeping.
- Sweating a lot.
- Irritation where fentanyl sublingual spray is used.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Fentanyl Sublingual Spray?
- Store at room temperature. Do not freeze.
- Store fentanyl sublingual spray in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep fentanyl sublingual spray safe. Keep all drugs away from pets.
- Follow the information that comes with fentanyl sublingual spray for throwing out doses that are not needed. Check with your pharmacist if you have questions about how to throw out fentanyl sublingual spray.
Consumer information use
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time fentanyl sublingual spray is refilled. If you have any questions about fentanyl sublingual spray, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Frequently asked questions
More about fentanyl
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- During Pregnancy or Breastfeeding
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.