May 25, 2017
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(fentanyl buccal) Soluble Film



Respiratory Depression

Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.

Due to the risk of respiratory depression, ONSOLIS is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see CONTRAINDICATIONS] ONSOLIS must be kept out of reach of children. [See PATIENT INFORMATION and HOW SUPPLIED/Storage and Handling]

The concomitant use of ONSOLIS with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see DRUG INTERACTIONS].

Medication Errors

Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.

  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products toONSOLIS.
  • When dispensing, do not substitute an ONSOLIS prescription for other fentanyl products.

Abuse Potential

ONSOLIS contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ONSOLIS can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ONSOLIS in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Because of the risk for misuse, abuse, addiction, and overdose, Onsolis is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program [see WARNINGS AND PRECAUTIONS]. Further information is available at or by calling 1-866-822-1483.


Onsolis (fentanyl buccal soluble film) is an oral transmucosal form of the potent opioid analgesic, fentanyl citrate, intended for application to the buccal mucosa. Onsolis uses the BioErodible MucoAdhesive (BEMA™) bilayer delivery technology which is comprised of water-soluble polymeric films. Onsolis consists of a printed white bioadhesive layer bonded onto a white inactive layer. The active ingredient, fentanyl citrate, is incorporated into the bioadhesive layer, which adheres to the moist buccal mucosa. The amount of fentanyl delivered transmucosally is proportional to the film surface area. It is believed that the inactive layer isolates the bioadhesive layer from the saliva, which may optimize delivery of fentanyl across the buccal mucosa.

Active Ingredient

Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. Fentanyl citrate has the following structural formula:

Onsolis (fentanyl citrate) Structural Formula Illustration

Inactive Ingredients

black ink, carboxymethylcellulose, citric acid, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, , sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic sodium phosphate, vitamin E acetate, and water.

What are the possible side effects of fentanyl buccal (Fentora, Onsolis)?

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.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting,...

Read All Potential Side Effects and See Pictures of Onsolis »

What are the precautions when taking fentanyl buccal soluble film (Onsolis)?

Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating...

Read All Potential Precautions of Onsolis »

Last reviewed on RxList: 1/11/2017
This monograph has been modified to include the generic and brand name in many instances.

Onsolis - User Reviews

Onsolis User Reviews

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