Hydromorphone
Dilaudid, Hydromorphone (hydromorphone) is a small molecule pharmaceutical. Hydromorphone was first approved as Dilaudid-hp on 1984-01-11. It is used to treat cough and postoperative pain in the USA. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target kappa-type opioid receptor and delta-type opioid receptor.
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Commercial
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Trade Name
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Dilaudid, Hydromorphone (discontinued: Dilaudid, Exalgo, Hydromorphone, Palladone)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydromorphone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DILAUDID | Fresenius Kabi | N-019034 RX | 2009-04-30 | 5 products, RLD, RS |
| HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals | N-217812 RX | 2023-12-14 | 1 products, RLD, RS |
| HYDROMORPHONE HYDROCHLORIDE | Hospira | N-200403 RX | 2011-12-01 | 5 products |
| DILAUDID | Rhodes Pharmaceuticals | N-019891 RX | 1992-12-07 | 1 products, RLD, RS |
| DILAUDID | Rhodes Pharmaceuticals | N-019892 RX | 1992-12-07 | 3 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dilaudid | New Drug Application | 2025-12-31 |
| exalgo | New Drug Application | 2013-01-28 |
| hydromorphone hcl | unapproved drug other | 2014-08-20 |
| hydromorphone hydrochloride | NDA authorized generic | 2026-01-29 |
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Clinical
Clinical Trials
329 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | 4 | 4 | 40 | 23 | 71 |
| Pain | D010146 | EFO_0003843 | R52 | 5 | 7 | 17 | 17 | 14 | 60 |
| Acute pain | D059787 | — | R52 | 3 | 7 | 7 | 9 | 4 | 29 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 7 | 9 | 1 | 3 | 4 | 23 |
| Cancer pain | D000072716 | — | G89.3 | — | 2 | 10 | 3 | 3 | 18 |
| Chronic pain | D059350 | — | — | 2 | 1 | 7 | 5 | — | 15 |
| Neoplasms | D009369 | — | C80 | — | 3 | 3 | 3 | 3 | 12 |
| Analgesia | D000698 | — | — | 2 | 4 | 2 | 2 | 1 | 11 |
| Agnosia | D000377 | EFO_0007136 | F88 | 2 | 2 | 2 | 2 | 2 | 10 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 2 | 1 | 7 |
Show 90 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | 3 | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | 2 | 4 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | 3 | — | — | 3 |
| Mucositis | D052016 | EFO_1001898 | — | — | 1 | 2 | — | — | 3 |
| Heroin dependence | D006556 | EFO_0004240 | — | — | — | 1 | — | 2 | 3 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | 1 | — | 1 | 2 |
| Obstetrical anesthesia | D000773 | — | — | 1 | — | 1 | — | — | 2 |
| Hernia | D006547 | — | K40-K46 | — | — | 1 | — | 1 | 2 |
| Spinal anesthesia | D000775 | — | — | — | — | 1 | — | 1 | 2 |
| Cystectomy | D015653 | — | — | — | — | 1 | — | — | 1 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 3 | 1 | — | — | 1 | 5 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | 1 | 2 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | 1 | — | — | — | 2 |
| Cannabis | D002188 | — | — | — | 2 | — | — | — | 2 |
| Anesthesia and analgesia | D000760 | — | — | — | 1 | — | — | 1 | 2 |
| Pruritus | D011537 | — | L29 | — | 1 | — | — | — | 1 |
| Vertigo | D014717 | — | H81.39 | — | 1 | — | — | — | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 1 | — | — | — | 1 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 1 | — | — | — | 1 |
| Musculoskeletal diseases | D009140 | — | — | — | 1 | — | — | — | 1 |
Show 16 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Musculoskeletal pain | D059352 | — | — | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | 1 | — | — | — | — | 1 |
| Spondylosis | D055009 | — | M47 | 1 | — | — | — | — | 1 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | — | — | — | — | 1 |
| Chronic limb-threatening ischemia | D000089802 | — | — | 1 | — | — | — | — | 1 |
| Cocaine-related disorders | D019970 | — | F14 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Delirium | D003693 | — | R41.0 | — | — | — | — | 4 | 4 |
| Local anesthesia | D000772 | — | — | — | — | — | — | 3 | 3 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 3 | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 2 | 2 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 2 | 2 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 2 | 2 |
| Conduction anesthesia | D000765 | — | — | — | — | — | — | 2 | 2 |
| Drug-seeking behavior | D058999 | — | — | — | — | — | — | 2 | 2 |
| Nerve block | D009407 | — | — | — | — | — | — | 1 | 1 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 1 | 1 |
Show 36 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydromorphone |
| INN | hydromorphone |
| Description | Hydromorphone is a morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class. It has a role as an opioid analgesic and a mu-opioid receptor agonist. It is a morphinane alkaloid and an organic heteropentacyclic compound. It derives from a hydride of a morphinan. |
| Classification | Small molecule |
| Drug class | Opioid |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@H]3[C@H]1C5 |
Identifiers
| PDB | — |
| CAS-ID | 466-99-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL398707 |
| ChEBI ID | 5790 |
| PubChem CID | 5284570 |
| DrugBank | DB00327 |
| UNII ID | Q812464R06 (ChemIDplus, GSRS) |
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Hydromorphone
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Safety
Black-box Warning
Black-box warning for: Dilaudid, Exalgo, Hydromorphone hydrochloride
Adverse Events
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89,474 adverse events reported
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