Hydromorphone

Overview

Hydromorphone is a pure opioid, a semi-synthetic hydrogenated ketone derivative of morphine that has been available clinically since 1920. Structurally, hydromorphone derived from morphine in the modification of the hydroxyl group in the carbon 6 to a carbonyl and the absence of a double bond between the carbon 7 and 8. Due to these modifications, it presents a very high potency and comparable side effect profile to the parent compound. Even though hydromorphone does not present a 6-hydroxyl group, it is categorized under the family of phenanthrenes and it is considered a chemical under the schedule II (medical purposes with high addiction potential). The first reported approved product containing hydromorphone in the form of hydromorphone hydrochloride was developed by Fresenius Kabi USA and FDA approved in 1984.

Indication

Hydromorphone is indicated for the management of moderate to severe acute pain and severe chronic pain. Due to its addictive potential and overdose risk, hydromorphone is only prescribed when other first-line treatments have failed. The WHO has proposed a three-step ladder for the management of pain in which it is suggested to start with a non-opioid medication followed by addition of weak opioids to the non-opioid treatment for moderate pain and finishing in the use of strong opioids such as hydromorphone along with the existing regimen for cases of severe pain. Off-label, hydromorphone can be administered for the suppression of refractory cough.

Associated Conditions

Neuropathic Pain
Refractory Chronic Cough
Moderate to severe pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intravenous Hydromorphone for the Treatment of Acute Pain	2025/04/29	NCT06949059	Phase 1	Recruiting	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Reducing Pain With Methadone and Ketamine in Liver Transplant	2025/03/11	NCT06868589	Phase 4	Recruiting	Lahey Clinic
The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial	2025/01/21	NCT06785571	Phase 2	Recruiting	Wuhan Union Hospital, China
Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine	2025/01/20	NCT06784180	Phase 4	Recruiting	University of North Carolina, Chapel Hill
Personalized Post-Operative Pain Management	2024/11/01	NCT06669650	Phase 4	Active, not recruiting	University of Tennessee Graduate School of Medicine
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.	2024/10/01	NCT06617949	Early Phase 1	Recruiting	Medical College of Wisconsin
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery	2024/07/29	NCT06525740	Phase 4	Recruiting	Mayo Clinic
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy	2024/05/13	NCT06411795	Phase 2	Recruiting	Masonic Cancer Center, University of Minnesota
Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).	2024/05/09	NCT06406400	Phase 1	Terminated	AstraZeneca
Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery	2024/03/20	NCT06320041	Phase 4	Recruiting	The Fourth Affiliated Hospital of Zhejiang University School of Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Hydromorphone Hydrochloride	Teva Parenteral Medicines, Inc.	0703-0018	INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR	10 mg in 1 mL	9/21/2022
Hydromorphone Hydrochloride	Hospira, Inc.	0409-1312	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	2 mg in 1 mL	12/26/2023
hydromorphone hydrochloride	Ascent Pharmaceuticals, Inc.	43602-266	ORAL	8 mg in 1 1	9/24/2020
Hydromorphone Hydrochloride	Akorn	17478-540	INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR	10 mg in 1 mL	6/1/2020
Hydromorphone Hydrochloride	Teva Parenteral Medicines, Inc.	0703-0110	INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR	10 mg in 1 mL	9/21/2022
EXALGO	Physicians Total Care, Inc.	54868-6387	ORAL	8 mg in 1 1	1/28/2013
Hydromorphone Hydrochloride	H.J. Harkins Company, Inc.	52959-413	ORAL	8 mg in 1 1	12/8/2011
Hydromorphone Hydrochloride	Bryant Ranch Prepack	72162-1081	ORAL	2 mg in 1 1	5/10/2023
EXALGO	STAT Rx USA LLC	16590-942	ORAL	8 mg in 1 1	11/8/2011
Hydromorphone Hydrochloride	American Health Packaging	60687-590	ORAL	4 mg in 1 1	12/11/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MEDSURGE HYDROMORPHONE XHP 50 mg/1 mL hydromorphone hydrochloride 50 mg/1 mL concentrated injection ampoule	309686	Medsurge Pharma Pty Ltd	Medicine	A	11/8/2019
HYDROMORPHONE JUNO hydromorphone hydrochloride 2 mg/1 mL injection solution ampoules	303503	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/6/2019
MEDICIANZ HYDROMORPHONE HP 10 mg/1 mL hydromorphone hydrochloride 10 mg/1 mL injection ampoule	309685	Medsurge Pharma Pty Ltd	Medicine	A	11/8/2019
DILAUDID hydromorphone hydrochloride 2mg/1mL injection ampoule	272632	Mundipharma Pty Ltd	Medicine	A	9/9/2016
DILAUDID hydromorphone hydrochloride 2mg tablet bottle	67353	Mundipharma Pty Ltd	Medicine	A	8/20/1999
DILAUDID-HP hydromorphone hydrochloride 10mg/1mL injection ampoule	272633	Mundipharma Pty Ltd	Medicine	A	9/9/2016
HYDROMORPHONE JUNO-HP hydromorphone hydrochloride 10 mg/1 mL injection solution ampoules	303502	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/6/2019
HYDROMORPHONE JUNO-HP hydromorphone hydrochloride 50 mg/5 mL injection solution ampoules	303504	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/6/2019
MEDICIANZ HYDROMORPHONE 2 mg/1 mL hydromorphone hydrochloride 2 mg/1 mL injection ampoule	309681	Medsurge Pharma Pty Ltd	Medicine	A	11/8/2019
MEDICIANZ HYDROMORPHONE XHP 50 mg/1 mL hydromorphone hydrochloride 50 mg/1 mL concentrated injection ampoule	309687	Medsurge Pharma Pty Ltd	Medicine	A	11/8/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DILAUDID	purdue pharma	00705438	Tablet - Oral	1 MG	12/31/1986
BAR-HYDROMORPHONE CR	bard pharmaceuticals (1990) inc	02460777	Capsule (Extended Release) - Oral	3 MG	N/A
DILAUDID	purdue pharma	00125121	Tablet - Oral	4 MG	12/31/1984
BAR-HYDROMORPHONE CR	bard pharmaceuticals (1990) inc	02460815	Capsule (Extended Release) - Oral	12 MG	N/A
HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 18MG	purdue pharma	02243562	Capsule (Sustained-Release) - Oral	18 MG	7/3/2001
TEVA-HYDROMORPHONE	teva canada limited	02319446	Tablet - Oral	8 MG	11/16/2011
PHL-HYDROMORPHONE	pharmel inc	02249901	Suppository - Rectal	3 MG	N/A
HYDROMORPHONE HYDROCHLORIDE INJECTION, USP	fresenius kabi canada ltd	02491680	Solution - Intramuscular , Intravenous , Subcutaneous	10 MG / ML	11/10/2020
BAR-HYDROMORPHONE CR	bard pharmaceuticals (1990) inc	02460831	Capsule (Extended Release) - Oral	24 MG	N/A
BAR-HYDROMORPHONE CR	bard pharmaceuticals (1990) inc	02460807	Capsule (Extended Release) - Oral	9 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

Health Canada Drug Approvals

CIMA AEMPS Drug Approvals

Philippines FDA Drug Approvals

Saudi SFDA Drug Approvals

Malaysia NPRA Drug Approvals

UK EMC Drug Information

Related News

FDA Approves Abuse-Deterrent Roxybond 10mg for Pain Management

FDA Approves Protega's Abuse-Deterrent ROXYBOND 10 mg for Severe Pain

Philadelphia Hospitals Pioneer New Strategy for Treating 'Tranq Dope' Withdrawal

Help Us Improve

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