FDA label
What is tramadol used for?
The FDA-approved uses of tramadol, 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: “Tramadol hydrochloride extended-release tablets are 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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Tramadol Hydrochloride, tablet, extended release
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA091607). Cross-references to other label sections are left out.
Tramadol hydrochloride extended-release tablets are 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 tramadol hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id dc420d50-6192-482d-b3da-3be55870a79a, version 28, effective December 5, 2025. NDC 47335-531, one of 51 listings for this product.
Tramadol Hydrochloride, tablet, coated
Indications and Usage, quoted from the label by Amneal Pharmaceuticals NY LLC (ANDA076003). Cross-references to other label sections are left out.
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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 tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 8ec4e4e5-a56e-4198-8428-6b770b9bf27d, version 5, effective June 6, 2026. NDC 60219-2348, one of 34 listings for this product.
Questions
What is tramadol used for?
The FDA label says: “Tramadol hydrochloride extended-release tablets are 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 tramadol?
FDA lists tramadol in the 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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