Two medicines, side by side
Hydromorphone vs oxymorphone
Hydromorphone and oxymorphone are both labeled for pain. Drugs@FDA records approvals of hydromorphone since 1984 and of oxymorphone since 1959. How each works, in its label's words: Hydromorphone, “Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses.”; Oxymorphone, “Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses.”
Check it at the source: the hydromorphone FDA label on DailyMed (effective May 14, 2026); the oxymorphone FDA label on DailyMed (effective June 29, 2026).
Highlights of the hydromorphone record
Hydromorphone (Dilaudid) · label of May 14, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE See full prescribing information for complete boxed warning. Ensure accuracy when prescribing, dispensing, and administering hydromorphone hydrochloride oral solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.
Used for
From the label: indicationsHydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]
On the market
- Earliest approval on file
- January 11, 1984
- Generic labelers
- 13 labelers
- Pharmacy cost
- $0.219 per tablet
Supply and safety
- Shortage
- In shortage
- Recalls
- 30
Highlights of the oxymorphone record
Oxymorphone (Opana) · label of June 29, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS Addiction, Abuse, and Misuse Because the use of oxymorphone hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].
Used for
From the label: indicationsOxymorphone hydrochloride tablets is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]
On the market
- Earliest approval on file
- April 2, 1959
- Generic labelers
- 9 labelers
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Hydromorphone label of May 14, 2026, Oxymorphone label of June 29, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do hydromorphone and oxymorphone differ on the record?
How each works, in its label's words: Hydromorphone, “Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses.”; Oxymorphone, “Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses.”
Both are in FDA's class opioid agonists.
Half-life, in each label's words: Hydromorphone, “The terminal elimination half-life of hydromorphone after an intravenous dose is about 2.3 hours.”; Oxymorphone, “Elimination Oxymorphone hydrochloride tablets half-life ranges from approximately 9-11 hours after a single oral dose …”
Both labels carry a boxed warning; the records quote them.
Generics: hydromorphone since 1995; oxymorphone since 2010 (Drugs@FDA).
| Hydromorphone | Oxymorphone | |
|---|---|---|
| Labeled for | Pain | Pain |
| Pharmacologic class | Opioid Agonist | Opioid Agonist |
| How it works (label) | Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. | Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone is analgesia. |
| Half-life (label) | The terminal elimination half-life of hydromorphone after an intravenous dose is about 2.3 hours. | Elimination Oxymorphone hydrochloride tablets half-life ranges from approximately 9-11 hours after a single oral dose (5-40 mg). |
| Earliest approval on file (Drugs@FDA) | January 11, 1984 | April 2, 1959 |
| First generic approved | August 23, 1995 | June 14, 2010 |
| Generic labelers (NDC) | 13 labelers | 9 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.219 per tablet (Hydromorphone 4 mg tablet) | n/a |
| 12-month price change | +11% | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | In shortage | No current entry |
| Recalls recorded | 30 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 91,453 | 11,596 |
| DEA schedule | CII | CII |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Hydromorphone label, warnings and precautionsPatients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
Source: FDA drug labels via openFDA
What do the labels say about using others of their kind?
Hydromorphone label, warnings and precautionsRisks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants …
Oxymorphone label, warnings and precautionsRisks from Concomitant Use with Benzodiazepines and Other CNS Depressants Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on oxymorphone hydrochloride tablets therapy.
Source: FDA drug labels via openFDA
What next?
- Alternatives to hydromorphone
- every medicine labeled for the same conditions