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HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE is a drug. It is currently FDA-approved (first approved 1984).
At a glance
| Generic name | HYDROMORPHONE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
Boxed warnings
- WARNING: 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. ( 2.1 , 5.1 ) Hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.2 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets are essential. ( 5.3 ) Accidental ingestion of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets, especially by children, can result in a fatal overdose of hydromorphone. ( 5.3 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.4 , 7 ) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.5 ) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.6 ) Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering hydromorphone hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other hydromorphone oral solutions of different concentrations can result in accidental overdose and death [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Addiction, Abuse, and Misuse Because the use of hydromorphone hydrochloride oral solution and 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 and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.2) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets are essential [see Warnings and Precautions (5.3) ]. Accidental Ingestion Accidental ingestion of even one dose of hydromorphone hydrochloride oral solution or hydromorphone hydrochloride tablets, especially by children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.3) ] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . Reserve concomitant prescribing of hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.4) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [ see Warnings and Precautions (5.5)] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.6) ].
Common side effects
- Lightheadedness
- Dizziness
- Sedation
- Nausea
- Vomiting
- Sweating
- Flushing
- Dysphoria
- Euphoria
- Dry mouth
- Pruritus
- Constipation
Serious adverse events
- Respiratory depression
- Apnea
- Respiratory arrest
- Cardiac arrest
- Circulatory depression
- Shock
- Serotonin syndrome
- Anaphylaxis
- Adrenal insufficiency
- Opioid-induced esophageal dysfunction
Key clinical trials
- Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain (EARLY_PHASE1)
- Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (NA)
- Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (PHASE4)
- Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (PHASE3)
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery (PHASE4)
- Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
- Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HYDROMORPHONE HYDROCHLORIDE CI brief — competitive landscape report
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Frequently asked questions about HYDROMORPHONE HYDROCHLORIDE
What is HYDROMORPHONE HYDROCHLORIDE?
HYDROMORPHONE HYDROCHLORIDE is a Small molecule drug.
When was HYDROMORPHONE HYDROCHLORIDE approved?
HYDROMORPHONE HYDROCHLORIDE was first approved on 1984.
What development phase is HYDROMORPHONE HYDROCHLORIDE in?
HYDROMORPHONE HYDROCHLORIDE is FDA-approved (marketed).
What are the side effects of HYDROMORPHONE HYDROCHLORIDE?
Common side effects of HYDROMORPHONE HYDROCHLORIDE include Lightheadedness, Dizziness, Sedation, Nausea, Vomiting, Sweating. Serious adverse events: Respiratory depression, Apnea, Respiratory arrest, Cardiac arrest.