What is fentanyl used for?

Indications and Usage, quoted from the label by SpecGx LLC (ANDA077154). Cross-references to other label sections are left out.

Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.

Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

Limitations of Use

• Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including fentanyl transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.

Source: DailyMed label, set id e15a7e9b-8025-49dd-9a6d-bafcccf1959f, version 58, effective April 30, 2026. NDC 0406-9037, one of 23 listings for this product.

Indications and Usage, quoted from the label by ALVOGEN (ANDA202097). Cross-references to other label sections are left out.

Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.

Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

Limitations of Use

• Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ], reserve opioid analgesics, including fentanyl transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.

Source: DailyMed label, set id 242759ef-cb6d-4e3e-9f8d-5e31efa1f289, version 27, effective March 2, 2026. NDC 47781-423, one of 13 listings for this product.

Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (ANDA210762). Cross-references to other label sections are left out.

Fentanyl Citrate Injection is indicated for:

• analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises.
• use as a narcotic analgesic supplement in general or regional anesthesia.
• administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia.
• use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.

Source: DailyMed label, set id 38d0c14a-a0c1-44cc-a939-0304eb8037d6, version 10, effective December 31, 2024. NDC 63323-806, one of 3 listings for this product.