Hydromorphone
Dilaudid (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 delta-type opioid receptor and kappa-type opioid receptor.
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Commercial
Trade Name
FDA
EMA
Dilaudid (generic drugs available since 1998-07-29, discontinued: Exalgo, Palladone)
Drug Products
FDA
EMA
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 | 3 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 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dilaudid | New Drug Application | 2021-03-08 |
| exalgo | New Drug Application | 2013-01-28 |
| hydromorphone hydrochloride | NDA authorized generic | 2023-06-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cough | HP_0012735 | D003371 | R05 |
| postoperative pain | — | D010149 | G89.18 |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
404 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 11 | 20 | 8 | 2 | 2 | 39 | |
| Septic shock | D012772 | A48.3 | 1 | 7 | 12 | 5 | 4 | 26 | |
| Adrenal insufficiency | D000309 | 4 | 3 | 3 | 8 | 3 | 20 | ||
| Sepsis | D018805 | A41.9 | — | 4 | 6 | 3 | 7 | 19 | |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 6 | — | 5 | 3 | 15 |
| Congenital adrenal hyperplasia | D000312 | E25.0 | 4 | 7 | 2 | 3 | 1 | 15 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | 3 | 9 | 13 |
| Healthy volunteers/patients | — | 5 | 1 | 1 | 2 | — | 9 | ||
| Addison disease | D000224 | E27.1 | 1 | 5 | 1 | 1 | 3 | 9 | |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 2 | 3 | 1 | — | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 1 | 12 | 10 | — | 2 | 24 | |
| Prostatic neoplasms | D011471 | C61 | 2 | 11 | 5 | — | 1 | 17 | |
| Lymphoma | D008223 | C85.9 | — | 6 | 6 | — | — | 12 | |
| Myeloid leukemia acute | D015470 | C92.0 | 6 | 3 | 2 | — | — | 10 | |
| Myelodysplastic syndromes | D009190 | D46 | 3 | — | 3 | — | — | 6 | |
| Heart arrest | D006323 | EFO_0009492 | I46 | 2 | 2 | 2 | — | 2 | 6 |
| Covid-19 | D000086382 | U07.1 | — | — | 2 | — | 3 | 5 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 3 | — | 1 | 4 |
| Bronchopulmonary dysplasia | D001997 | P27.8 | — | 2 | 2 | — | — | 4 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | 1 | 1 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | 2 | 4 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | 3 | — | — | 1 | 4 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 2 | — | — | 1 | 3 |
| Neoplasms | D009369 | C80 | — | 3 | — | — | — | 3 | |
| Burkitt lymphoma | D002051 | C83.7 | 1 | 3 | — | — | — | 3 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 3 | — | — | — | 3 |
| Biphenotypic leukemia acute | D015456 | C95.0 | — | 2 | — | — | — | 2 | |
| Head and neck neoplasms | D006258 | — | 1 | — | — | 1 | 2 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | 1 | 2 |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | — | — | — | 2 | 5 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | — | — | — | — | 2 |
| Hematologic neoplasms | D019337 | 1 | — | — | — | 1 | 2 | ||
| Blood pressure | D001794 | EFO_0004325 | 2 | — | — | — | — | 2 | |
| T-cell lymphoma | D016399 | 2 | — | — | — | — | 2 | ||
| Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | 1 | 2 | |
| Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | 1 | 2 | |
| Infections | D007239 | EFO_0000544 | 1 | — | — | — | 1 | 2 | |
| Recurrence | D012008 | 2 | — | — | — | — | 2 | ||
| T-cell lymphoma peripheral | D016411 | C84.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 3 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 2 | 2 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | 2 | 2 | |
| Pituitary diseases | D010900 | E23.7 | — | — | — | — | 1 | 1 | |
| Circadian rhythm sleep disorders | D020178 | G47.2 | — | — | — | — | 1 | 1 | |
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | — | — | — | 1 | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | — | 1 | 1 |
| Orthostatic hypotension | D007024 | I95.1 | — | — | — | — | 1 | 1 | |
| Hypothermia | D007035 | HP_0002045 | T68 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
Show 39 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 | — |
| 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 | 3423 |
| ChEMBL ID | CHEMBL398707 |
| ChEBI ID | 5790 |
| PubChem CID | 5284570 |
| DrugBank | DB00327 |
| UNII ID | Q812464R06 (ChemIDplus, GSRS) |
Target
Variants
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Trends
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Safety
Black-box Warning
Black-box warning for: Dilaudid, Exalgo, Hydromorphone hydrochloride
Adverse Events
Top Adverse Reactions
0 adverse events reported
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