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Drug ReportsHydromorphone
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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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dilaudid, Hydromorphone (discontinued: Dilaudid, Exalgo, Hydromorphone, 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
DILAUDIDFresenius KabiN-019034 RX2009-04-30
5 products, RLD, RS
HYDROMORPHONE HYDROCHLORIDEHikma PharmaceuticalsN-217812 RX2023-12-14
1 products, RLD, RS
HYDROMORPHONE HYDROCHLORIDEHospiraN-200403 RX2011-12-01
5 products
DILAUDIDRhodes PharmaceuticalsN-019891 RX1992-12-07
1 products, RLD, RS
DILAUDIDRhodes PharmaceuticalsN-019892 RX1992-12-07
3 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dilaudidNew Drug Application2025-04-28
exalgoNew Drug Application2013-01-28
hydromorphone hclunapproved drug other2014-08-20
hydromorphone hydrochlorideANDA2025-09-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postoperative pain—D010149G89.18
cough—D003371R05
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Hydromorphone Hydrochloride, Dilaudid, Fresenius Kabi Usa
92482292034-03-12DP
97310822032-04-23DP
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA03: Hydromorphone
— N02AA53: Hydromorphone and naloxone
— N02AG: Opioids in combination with antispasmodics
— N02AG04: Hydromorphone and antispasmodics
HCPCS
Code
Description
J1170
Injection, hydromorphone, up to 4 mg
S0092
Injection, hydromorphone hydrochloride, 250 mg (loading dose for infusion pump)
Clinical
Clinical Trials
326 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 painD010149—G89.18———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic painD059350————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydromorphone
INNhydromorphone
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 classOpioid
Image (chem structure or protein)Loading
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-ID466-99-9
RxCUI—
ChEMBL IDCHEMBL398707
ChEBI ID5790
PubChem CID5284570
DrugBankDB00327
UNII IDQ812464R06 (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
Organism
Homo sapiens
Gene name
OPRM1
Gene synonyms
MOR1
NCBI Gene ID
4988
Protein name
mu-type opioid receptor
Protein synonyms
hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a
Uniprot ID
Q9UN57
Mouse ortholog
Oprm1 (18390)
mu-type opioid receptor (Q9R1M0)
Alternate
OPRK1
OPRK1
OPRD1
OPRD1
Organism
Homo sapiens
Gene name
OPRK1
Gene synonyms
OPRK
NCBI Gene ID
4986
Protein name
kappa-type opioid receptor
Protein synonyms
kappa opioid receptor, Opiate receptor, kappa-1
Uniprot ID
Q499G4
Mouse ortholog
Oprk1 (18387)
kappa-type opioid receptor (P33534)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Hydromorphone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,995 documents
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Safety
Black-box Warning
Black-box warning for: Dilaudid, Exalgo, Hydromorphone hydrochloride
Adverse Events
Top Adverse Reactions
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88,957 adverse events reported
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