Two medicines, side by side
Codeine vs hydromorphone
Codeine and hydromorphone are both labeled for pain. Drugs@FDA records approvals of codeine since 2009 and of hydromorphone since 1984. Pharmacies paid $0.726 per codeine sulfate 30 mg tablet and $0.219 per hydromorphone 4 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: Codeine, “Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.”; 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.”
Check it at the source: the codeine FDA label on DailyMed (effective December 22, 2025); the hydromorphone FDA label on DailyMed (effective May 14, 2026).
Highlights of the codeine record
Codeine · label of December 22, 2025
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of Codeine Sulfate 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 ), Dosage and Administration ( 2.1 )].
Used for
From the label: indicationsCodeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. […]
On the market
- Earliest approval on file
- July 16, 2009
- Generic labelers
- 1 labeler
- Pharmacy cost
- $0.726 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
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
Source: FDA drug labels via openFDA (Codeine label of December 22, 2025, Hydromorphone label of May 14, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do codeine and hydromorphone differ on the record?
How each works, in its label's words: Codeine, “Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.”; 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.”
Both are in FDA's class opioid agonists.
Both labels carry a boxed warning; the records quote them.
Generics: codeine since 2014; hydromorphone since 1995 (Drugs@FDA).
| Codeine | Hydromorphone | |
|---|---|---|
| Labeled for | Pain | Pain |
| Pharmacologic class | Opioid Agonist | Opioid Agonist |
| How it works (label) | Codeine sulfate is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. | 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. |
| Half-life (label) | n/a | The terminal elimination half-life of hydromorphone after an intravenous dose is about 2.3 hours. |
| Earliest approval on file (Drugs@FDA) | July 16, 2009 | January 11, 1984 |
| First generic approved | June 13, 2014 | August 23, 1995 |
| Generic labelers (NDC) | 1 labeler | 13 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.726 per tablet (Codeine sulfate 30 mg tablet) | $0.219 per tablet (Hydromorphone 4 mg tablet) |
| 12-month price change | +8% | +11% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | In shortage |
| Recalls recorded | 0 | 30 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 3,295 | 91,453 |
| 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?
Codeine 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 Codeine Sulfate Tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids …
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 …
Source: FDA drug labels via openFDA
What next?
- Alternatives to codeine
- every medicine labeled for the same conditions