Two medicines, side by side
Hydromorphone vs tramadol
Hydromorphone and tramadol are both labeled for pain. Drugs@FDA records approvals of hydromorphone since 1984 and of tramadol since 1995. Pharmacies paid $0.219 per hydromorphone 4 mg tablet and $0.0248 per tramadol HCl 50 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. 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.”; Tramadol, “Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.”
Check it at the source: the hydromorphone FDA label on DailyMed (effective May 14, 2026); the tramadol FDA label on DailyMed (effective March 5, 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 tramadol record
Tramadol (Ultram) · label of March 5, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of Tramadol hydrochloride extended-release tablet 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: indicationsTramadol hydrochloride extended-release tablet 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. […]
On the market
- Earliest approval on file
- March 3, 1995
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.0248 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 8
Source: FDA drug labels via openFDA (Hydromorphone label of May 14, 2026, Tramadol label of March 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do hydromorphone and tramadol 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.”; Tramadol, “Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin.”
Both are in FDA's class opioid agonists.
Both labels carry a boxed warning; the records quote them.
Generics: hydromorphone since 1995; tramadol since 2002 (Drugs@FDA).
DEA schedule: hydromorphone CII; tramadol CIV.
| Hydromorphone | Tramadol | |
|---|---|---|
| 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. | Tramadol hydrochloride extended-release tablet contains tramadol, an opioid agonist and an inhibitor of reuptake of norepinephrine and serotonin. |
| Half-life (label) | The terminal elimination half-life of hydromorphone after an intravenous dose is about 2.3 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | January 11, 1984 | March 3, 1995 |
| First generic approved | August 23, 1995 | June 19, 2002 |
| Generic labelers (NDC) | 13 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.219 per tablet (Hydromorphone 4 mg tablet) | $0.0248 per tablet (Tramadol HCl 50 mg tablet) |
| 12-month price change | +11% | -1% |
| Boxed warning | Yes | Yes |
| Shortage now | In shortage | No current entry |
| Recalls recorded | 30 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 91,453 | 37,421 |
| DEA schedule | CII | CIV |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
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 …
Tramadol 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 tramadol hydrochloride extended-release tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics …
Source: FDA drug labels via openFDA
What next?
- Alternatives to hydromorphone
- every medicine labeled for the same conditions