Sublimaze (Injection)

Fentanyl injection is used to ease severe pain during and after surgery. It is also used with other medicines right before or during a procedure to enhance the effect of the anesthetic (numbing medicine).

Fentanyl is part of a group of medicines known as narcotic analgesics (pain medicines). It works in the central nervous system (CNS) or brain to relieve pain. Some side effects, like drowsiness or dizziness, are also due to its effects in the CNS.

This medicine is to be given only by or under the immediate supervision of your doctor.

It is very important that your doctor monitors you closely while you or your child are receiving this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep using it.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical help. Call your doctor right away if you or your child experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Do not use more of this medicine or use it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor immediately if you notice these symptoms.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when standing up quickly from a lying or sitting position. Getting up slowly may help reduce this issue. Additionally, lying down for a while may relieve the dizziness or lightheadedness.

This medicine will increase the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or reduce alertness. Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping pills, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor or dentist before taking any of the above while you or your child are receiving this medicine.

This medicine may cause sleep-related breathing problems (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause dizziness, drowsiness, confusion, or disorientation. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or less alert.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for guidance.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may advise you to take laxatives, drink plenty of fluids, or increase your fiber intake. Be sure to follow these instructions carefully, as ongoing constipation can result in more serious issues.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or stop using it suddenly without consulting your doctor. Your doctor may want you to gradually decrease the amount you are using before stopping completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

This medicine may increase the risk of muscle rigidity and movement issues. Inform your doctor if you or your child experience stiff or rigid muscles after using this medicine.

Contact your doctor immediately if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or experience hallucinations. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you are also taking certain other medicines that affect serotonin levels in your body.

Using this medicine during pregnancy may lead to neonatal withdrawal syndrome in your newborn. Inform your doctor right away if your baby shows signs such as an unusual sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.

Taking too much of this medicine may reduce fertility (ability to have children). Discuss with your doctor before using this medicine if you plan to have children.

Do not eat grapefruit or drink grapefruit juice while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fentanyl injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl injection in the elderly. However, elderly patients are more likely to have age-related lung, kidney, liver, or heart issues, which may require caution and an adjustment in the dose for patients receiving fentanyl injection.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances before taking this medication while breastfeeding.

Interactions with Drugs

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medication, it is especially essential that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Levoketoconazole
• Mifepristone
• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following drugs is usually not recommended, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

• Abametapir
• Acepromazine
• Adagrasib
• Alefacept
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asciminib
• Asenapine
• Atazanavir
• Avacopan
• Baclofen
• Belzutifan
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Berotralstat
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Cariprazine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Eluxadoline
• Enflurane
• Enzalutamide
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lanreotide
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Milnacipran
• Mirtazapine
• Mitotane
• Mobocertinib
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicardipine
• Nicomorphine
• Nifedipine
• Nilotinib
• Nirmatrelvir
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Octreotide
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pazopanib
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Sotorasib
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tacrolimus
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Trofinetide
• Tryptophan
• Tucatinib
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Adrenal issues or
• Brain tumor, history of or
• Breathing or lung problems (eg, COPD, respiratory depression, sleep apnea) or
• Cor pulmonale (severe heart condition) or
• Drug dependence, especially with narcotics, or history of or
• Head injury, history of or
• Heart disease or
• Hypokalemia (low potassium levels in the blood) or
• Hypomagnesemia (low magnesium levels in the blood)—Use with caution. May increase risk for more severe adverse effects.

• Bradycardia (slow heart rhythm) or
• Gallbladder problems or
• Heart rhythm issues (eg, QT prolongation) or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Pancreatitis (inflammation or swelling of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its needed effects, Sublimaze (Injection) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Chest pain or discomfort
• Difficult or troubled breathing
• Irregular, fast or slow, or shallow breathing
• Lightheadedness, dizziness, or fainting
• Pale or blue lips, fingernails, or skin
• Severe muscle stiffness
• Slow or irregular heartbeat
• Unusual tiredness

Incidence not known

• Blurred vision
• Change in consciousness
• Chills
• Confusion
• Cough
• Difficulty with swallowing
• Fast heartbeat
• Feeling cold
• Headache
• Hives, itching, or skin rash
• Inability to move the eyes
• Inability to sit still
• Increased blinking or spasms of the eyelid
• Nervousness
• Pounding in the ears
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Restlessness
• Seeing, hearing, or feeling things that are not there
• Sticking out the tongue when not meaning to
• Sweating
• Tightness in the chest
• Uncontrolled twisting movements of the neck, trunk, arms, or legs
• Unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Sublimaze (Injection). Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Increased sweating
• Redness of the skin
• Vomiting
• Welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Sublimaze

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given as a shot into a muscle or vein.

• What drugs cause pinpoint pupils?
• Which drugs cause opioid-induced constipation?
• How long does Fentanyl stay in your system?
• Carfentanil vs Fentanyl: Which is more dangerous?
• Fentanyl test strips: where to get & how to use?
• Why is fentanyl so dangerous?
• What are the symptoms of a fentanyl overdose?
• How does fentanyl compare to heroin or other opiates?
• Which painkiller should you use?

View more FAQ