Two medicines, side by side
Hydromorphone vs methadone
Hydromorphone and methadone are both labeled for pain. Drugs@FDA records approvals of hydromorphone since 1984 and of methadone since 1947. Pharmacies paid $0.219 per hydromorphone 4 mg tablet and $0.177 per methadone HCl 10 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.”; Methadone, “Methadone hydrochloride is a mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and …”
Check it at the source: the hydromorphone FDA label on DailyMed (effective May 14, 2026); the methadone FDA label on DailyMed (effective December 8, 2025).
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 methadone record
Methadone (Diskets) · label of December 8, 2025
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE TABLETS: Addiction, Abuse, and Misuse Because the use of methadone 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: indicationsMethadone hydrochloride tablets are indicated for the: 1. 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
- August 13, 1947
- Generic labelers
- 18 labelers
- Pharmacy cost
- $0.177 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Source: FDA drug labels via openFDA (Hydromorphone label of May 14, 2026, Methadone label of December 8, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do hydromorphone and methadone 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.”; Methadone, “Methadone hydrochloride is a mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and …”
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.”; Methadone, “Published reports indicate that after multiple dose administration the apparent plasma clearance of methadone ranged …”
Both labels carry a boxed warning; the records quote them.
Generics: hydromorphone since 1995; methadone since 1981 (Drugs@FDA).
| Hydromorphone | Methadone | |
|---|---|---|
| Labeled for | Pain | Pain, Opioid use disorder |
| 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. | Methadone hydrochloride is a mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and organs composed of smooth muscle. |
| Half-life (label) | The terminal elimination half-life of hydromorphone after an intravenous dose is about 2.3 hours. | Published reports indicate that after multiple dose administration the apparent plasma clearance of methadone ranged between 1.4 and 126 L/h, and the terminal half-life (T 1/2 ) was highly variable and ranged between 8 … |
| Earliest approval on file (Drugs@FDA) | January 11, 1984 | August 13, 1947 |
| First generic approved | August 23, 1995 | May 22, 1981 |
| Generic labelers (NDC) | 13 labelers | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.219 per tablet (Hydromorphone 4 mg tablet) | $0.177 per tablet (Methadone HCl 10 mg tablet) |
| 12-month price change | +11% | -7% |
| Boxed warning | Yes | Yes |
| Shortage now | In shortage | No current entry |
| Recalls recorded | 30 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 91,453 | 45,988 |
| 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)
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 …
Methadone 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 Methadone hydrochloride tablets with benzodiazepines and/or other CNS depressants (e.g., alcohol, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin …
Source: FDA drug labels via openFDA
What next?
- Alternatives to hydromorphone
- every medicine labeled for the same conditions