HYDROMORPHONE HYDROCHLORIDE
Hydromorphone hydrochloride is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Due to the risks of addiction, abuse, and misuse, it is reserved for patients where non-opioid analgesics or opioid combination products have not provided adequate analgesia, or are not expected to be tolerated.
How HYDROMORPHONE HYDROCHLORIDE Works
Hydromorphone is a full opioid agonist with relative selectivity for the mu-opioid receptor, though it may bind to other opioid receptors at higher doses. Its primary therapeutic effect is analgesia, mediated by binding to specific opioid receptors throughout the brain and spinal cord. As a full agonist, hydromorphone has no ceiling effect for analgesia; clinical dosage is titrated to effect and is primarily limited by adverse reactions such as respiratory and CNS depression.
Details
- Status
- Prescription
- First Approved
- 1995-08-23
- Routes
- ORAL, INJECTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- TABLET, INJECTABLE, TABLET, EXTENDED RELEASE, SOLUTION
Companies
HYDROMORPHONE HYDROCHLORIDE Approval History
What HYDROMORPHONE HYDROCHLORIDE Treats
1 indicationsHYDROMORPHONE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
HYDROMORPHONE HYDROCHLORIDE Boxed Warning
RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydromorphone Hydrochloride Tablets expose 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 t...
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydromorphone Hydrochloride Tablets expose 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 Hydromorphone Hydrochloride Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.2 )]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions ( 5.3 )]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Hydrochloride Tablets. Monitor for respiratory depression, especially during initiation of Hydromorphone Hydrochloride Tablets or following a dose increase [see Warnings and Precautions ( 5.4 )]. Accidental Ingestion Accidental ingestion of even one dose of Hydromorphone Hydroch
HYDROMORPHONE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to HYDROMORPHONE HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03214510 | 2016-1111 NCI-2018-01124, 2016-1111 | Ph 3 | active not recruiting | Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery |
| NCT01709721 results posted | CNS-HYD201US | Ph 3 | completed | Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration |
| NCT01709747 results posted | CNS-HYD202US | Ph 3 | completed | Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration |
| NCT02459964 results posted | 2015-0086 NCI-2015-01509 | Ph 4 | completed | Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain |
| NCT04081376 HM | IMIMFTCL/HM | Ph 1 | completed | Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYDROMORPHONE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)HYDROMORPHONE HYDROCHLORIDE is indicated for the treatment of Pain.
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Ab...
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DILAUDID
Full clinical data, patents, trials, and competitive landscape for hydromorphone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.