Is Fentanyl FDA Approved?

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Fentanyl is a synthetic opioid prescribed for treating severe pain, typically associated with advanced stages of cancer. It is 50 to 100 times more potent than morphine. Fentanyl is often misused in the United States and is a leading cause of the opioid epidemic in the United States.

Recently, fentanyl-related overdoses and deaths in the U.S. have been linked to illegally made fentanyl. Drug dealers sell it for its heroin-like effect. It is often mixed with heroin and cocaine, with or without the user’s knowledge, to increase its powerful effects.

Fentanyl deaths are on the rise. 100,000 people died from a drug overdose in 2021, and fentanyl was responsible for more than 60%. That same year, there were almost 123,000 fentanyl-related emergency department visits. Those numbers reveal a significant increase over the past several years.

Fentanyl is approved by the United States Food and Drug Administration (FDA) as a prescription medication for pain management and anesthesia and a treatment for breakthrough cancer pain in patients already receiving opioid medication. It is available in various forms, including transdermal patches, lozenges, nasal sprays, and injectable solutions. However, it is important to note that fentanyl is a highly potent and potentially dangerous medication and should only be used under the supervision of a qualified healthcare provider.

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Is Fentanyl Use FDA Approved?

As previously mentioned, fentanyl is an FDA-approved prescription medication for severe pain, anesthesia, and breakthrough cancer pain. It comes in various forms, such as transdermal patches, lozenges, nasal sprays, and injectable solutions.

This highly potent medication is primarily used to alleviate intense pain, such as pain associated with cancer or surgery. It may also be administered during surgery as an adjunct to general anesthesia to minimize the need for other anesthetic drugs. Fentanyl may also be utilized in palliative care to relieve individuals suffering from severe pain due to terminal illness.

According to the CDC, the rate of opioid prescriptions in the United States has decreased significantly. In 2020, the national opioid dispensing rate hit a record low of 43.3 prescriptions per 100 persons, the lowest in the last 15 years.

However, despite this positive trend, some regions in the country had alarmingly high dispensing rates. In fact, in 3.6% of U.S. counties, there were enough opioid prescriptions dispensed for every person in the area.

Furthermore, there were some counties where the opioid dispensing rate was as much as nine times higher than the national average of 43.3 prescriptions per 100 people. There is still work to be done to address the ongoing issue of opioid misuse and abuse and to promote safer and more effective pain management strategies.

Pharmaceutical Fentanyl Is FDA Approved for Pain Relief

Pharmaceutical fentanyl is an FDA-approved medication for the management of severe pain. It is a potent opioid typically prescribed for people who require continuous pain relief and have not responded to other pain medications or therapies. Fentanyl is available in several formulations, including transdermal patches, lozenges, nasal sprays, and injectable solutions. It is essential to use fentanyl only under the guidance of a qualified healthcare provider and as directed, as misuse or abuse can be extremely dangerous and even fatal.

Fentanyl is a potent opioid medication used for pain management because it is highly effective at relieving severe pain. It is often prescribed for people experiencing pain that cannot be managed with other medications or therapies, such as cancer or post-surgical pain. When used correctly, fentanyl can provide significant pain relief and improve the quality of life for people with severe pain.

The risk of addiction and overdose can be minimized by following safe prescribing practices, such as using the lowest effective dose for the shortest possible duration and closely monitoring patients for signs of misuse or abuse. In addition, healthcare providers can work with patients to explore alternative pain management strategies, such as physical therapy, cognitive-behavioral therapy, or non-opioid medications, that may effectively manage pain without the risk of addiction and overdose.

When Was Fentanyl Approved by the FDA for Cancer Breakthrough Pain?

Fentanyl was first approved by the FDA in 1968 as an anesthetic agent for use during surgery. However, its use for cancer breakthrough pain was not authorized until 1998, when the FDA approved the transdermal fentanyl patch to manage chronic pain in patients who require around-the-clock opioid therapy for an extended period and are tolerant to the effects of other opioid medications. The transdermal fentanyl patch provides continuous medication delivery, allowing for more consistent pain relief. Since then, different fentanyl formulations, including tablets, nasal sprays, and injectable solutions, have also been approved to manage breakthrough cancer pain.

What Is the Transmucosal Immediate Release Fentanyl (TIRF) REMS Program?

The Transmucosal Immediate Release Fentanyl (TIRF) REMS Program is a risk evaluation and mitigation strategy program designed to ensure the safe use of transmucosal immediate-release fentanyl (TIRF) medications. TIRF medications are a class of fentanyl products designed to provide rapid pain relief by delivering the medication through the mucous membranes of the mouth or nose.

The TIRF REMS Program was established by the FDA in 2011 and requires all manufacturers of TIRF medications to develop and implement a comprehensive risk management plan to minimize the risk of misuse, abuse, addiction, overdose, and other serious adverse events associated with these medications.

Under the TIRF REMS Program, healthcare providers who prescribe TIRF medications must complete specialized training and enroll in the program to ensure they understand their risks and safe use. Patients who receive TIRF medications must also be provided with a Medication Guide that includes information on the risks and safe use of these medications. The TIRF REMS Program is important to promote the safe and effective use of TIRF medications while minimizing the risk of serious adverse events.

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FDA’s Warnings on Fentanyl Patches & Accidental Exposure

The FDA has issued several warnings regarding using fentanyl patches to reduce the risk of accidental exposure and overdose. The signs are aimed at healthcare providers and patients using fentanyl patches for pain management.

One of the primary concerns with fentanyl patches is that they can be dangerous if they are not used correctly or if they come into contact with someone who does not intend to use them, such as children or pets. The FDA has advised healthcare providers to carefully assess patients before prescribing fentanyl patches and to provide clear instructions for using and disposing of the patches.

In addition, the FDA has recommended that patients use fentanyl patches only as directed and take steps to prevent accidental exposure, such as storing the patches out of reach of children and properly disposing of used patches by flushing them down the toilet. The FDA has also issued warnings about the potential for fentanyl patches to cause skin reactions. Healthcare providers have been advised to monitor patients for signs of skin irritation or damage.

The FDA’s warnings regarding fentanyl patches aim to promote these medications’ safe and effective use while minimizing the risk of accidental exposure, misuse, and overdose.

How to Dispose of Fentanyl Patches?

It is important to dispose of fentanyl patches properly to prevent accidental exposure and misuse. The FDA recommends the following steps for disposing of fentanyl patches:

  • Fold the used patch in half with the sticky sides together.
  • Flush the folded patch down the toilet immediately after removal. Do not place used patches in the trash.
  • Wash your hands with soap and water after handling the patch or any parts of it.

It is important to dispose of fentanyl patches promptly and adequately after use to prevent anyone else from being exposed to the medication accidentally. If you have any questions or concerns about disposing of fentanyl patches, ask your healthcare provider or pharmacist for guidance.

FDA Approved the Significantly More Potent Opioid Dsuvia

The FDA approved the opioid medication Dsuvia in 2018. Dsuvia is a brand name for the generic drug sufentanil, which is a synthetic opioid medication that is significantly more potent than other commonly used opioids like fentanyl and morphine.

Dsuvia is approved by the FDA only for use in medically supervised healthcare settings, such as hospitals, surgery centers, and emergency departments. It is intended to treat acute pain in adults requiring pain relief that other treatments cannot achieve.

The FDA approved Dsuvia with strict requirements for its distribution and use, including restrictions on prescribing and dispensing and required training for healthcare providers who administer the medication. The FDA also required the manufacturer to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure the safe use of the drug and minimize the risk of misuse, abuse, addiction, overdose, and other serious adverse events.

The approval of Dsuvia was controversial because of concerns about the potential for misuse and abuse of such a potent opioid medication. However, the FDA determined that the drug’s benefits in treating acute pain in appropriate patients outweighed the risks when used according to the approved label and with proper safeguards.

Use Case for Sublingual Desuvia as a Fentanyl Alternative

Dsuvia (sufentanil sublingual tablet) is a potent opioid medication that is FDA-approved for managing acute pain in medically supervised healthcare settings, such as hospitals and emergency departments. Dsuvia is intended for patients who require pain relief that other treatments cannot achieve.

One potential use case for Dsuvia is as an alternative to fentanyl for managing acute pain. While fentanyl is commonly used to manage moderate to severe pain, it can have significant risks associated with its use, including the potential for respiratory depression, overdose, and addiction.

Dsuvia may be considered an alternative to fentanyl in certain situations, such as for patients who are intolerant to or have had an inadequate response to other opioid medications. Because Dsuvia is highly potent, it may be effective in providing pain relief at lower doses than other opioid medications, which may reduce the risk of adverse effects.

Dsuvia, like other opioid medications, carries significant risks, including the potential for misuse, abuse, addiction, and overdose. Dsuvia should only be used in medically supervised healthcare settings with appropriate safeguards to minimize these risks. The decision to use Dsuvia should be made by a healthcare provider based on the patient’s individual needs and medical history.

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At Guardian Recovery, we remain dedicated to providing our clients with a comprehensive program of fentanyl detox — one that focuses on much more than physical stabilization. In addition to emphasizing physical recovery, we tackle mental, emotional, and spiritual well-being. While prioritizing a safe and pain-free drug withdrawal, we offer individualgroup, and family therapy sessions, case management services, relapse prevention training, and aftercare planning.

Contact us today if you or your loved one is ready to begin an entirely new way of life and commit to long-term recovery. As soon as you call, we start developing a plan of action that begins with an initial pre-assessment. This assessment helps us determine the most appropriate level of care for each unique case. We identify potential coverage options if our medically monitored detox program is a good fit. We work closely with most major regional and national insurance providers. Contact us today for a free, no-obligation insurance benefit check.


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Reviewed professionally for accuracy by:

Ryan Soave


Ryan Soave brings deep experience as a Licensed Mental Health Counselor, certified trauma therapist, program developer, and research consultant for Huberman Lab at Stanford University Department of Neurobiology. Post-graduation from Wake Forest University, Ryan quickly discovered his acumen for the business world. After almost a decade of successful entrepreneurship and world traveling, he encountered a wave of personal and spiritual challenges; he felt a calling for something more. Ryan returned to school and completed his Master’s Degree in Mental Health Counseling. When he started working with those suffering from addiction and PTSD, he found his passion. He has never looked back.

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Cayla Clark

Cayla Clark grew up in Santa Barbara, CA and graduated from UCLA with a degree in playwriting. Since then she has been writing on addiction recovery and psychology full-time, and has found a home as part of the Guardian Recovery team.

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