FDA label

What is hydromorphone used for?

The FDA-approved uses of hydromorphone, 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: “Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients 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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Hydromorphone Hydrochloride, tablet, extended release

Indications and Usage, quoted from the label by Trigen Laboratories, LLC (ANDA205629). Cross-references to other label sections are left out.

Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients 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.

Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral 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 hydromorphone 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.
  • Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.

Source: DailyMed label, set id 8bb81796-6990-40e9-bee4-1f292f91ae99, version 29, effective December 25, 2025. NDC 13811-701, one of 16 listings for this product.

Hydromorphone Hydrochloride, tablet

Indications and Usage, quoted from the label by SpecGx LLC (ANDA076855). Cross-references to other label sections are left out.

Hydromorphone hydrochloride tablets are indicated 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 hydromorphone 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 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2, version 29, effective July 2, 2026. NDC 0406-3243, one of 13 listings for this product.

Hydromorphone Hydrochloride, injection

Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA202159). Cross-references to other label sections are left out.

Hydromorphone hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate 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 hydromorphone hydrochloride injection 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 67e79859-4efc-4ea7-8211-cadf746bc864, version 9, effective July 30, 2026. NDC 0641-6151, one of 5 listings for this product.

Questions

What is hydromorphone used for?

The FDA label says: “Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients 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 hydromorphone?

FDA lists hydromorphone 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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