FDA label
What is Butrans used for?
Butrans contains buprenorphine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
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Indications and Usage, quoted from the label by Knoa Pharma LLC (NDA021306). Cross-references to other label sections are left out.
BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
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 BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- BUTRANS is not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id 794aa355-66de-41b8-aedf-f2c40f6bc664, version 32, effective May 1, 2026. NDC 59011-750, one of 5 listings for this product.
Questions
What is Butrans used for?
The FDA label says: “BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
What drug class is Butrans?
FDA lists buprenorphine in the Partial Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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- NDC 59011-752Butrans NDC record
- Schedule III drugs listDEA schedule