Morphine Sulfate Tablets: US FDA label indications

US FDA labelNot medical advice

The product name above is taken from the label's own indications text; the source record has no brand or generic name field.

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE Morphine Sulfate Tablets are indicated for the management of: adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1 ) ] , reserve Morphine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Pediatric use information is approved for Hikma Pharmaceuticals USA Inc.’s morphine sulfate tablets. However, due to Hikma Pharmaceuticals USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Morphine Sulfate Tablets are an opioid agonist indicated for the management of: adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Su…

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( 5.6 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.8 ) Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Tablets in patients with circulatory shock. ( 5.9 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Tablets in patients with impaired consciousness or coma. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Morphine Sulfate Tablets contain morphine, a Schedule II controlled substance. As an opioid, Morphine Sulfate Tablets expose users to the risks of addiction, abuse, and misuse [see Drug A…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).

Trials whose interventions mention this drug

Canadian trials first. Showing 50 of 62. A match on the drug name does not mean the trial studied this specific product.

50 trials, recruiting first

		Phase	Countries
A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain NCT03967327	Unknown status	Phase 3	China	Mundipharma (China) Pharmaceutical Co. Ltd	2019-04-22
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain NCT03761277	Completed	Phase 4	United States	MedtronicNeuro	2019-01-16
Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section NCT03451695	Completed	Phase 4	Nepal	B.P. Koirala Institute of Health Sciences	2018-04-01
Effect of Combined Morphine and Duloxetine on Chronic Pain NCT03249558	Completed	Phase 4	United States	Massachusetts General Hospital	2018-03-12
Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain NCT03275012	Withdrawn	Phase 2		Pharmaceutical Research Management srl	2017-04-04
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain NCT02824276	Completed	Phase 1	United States	Brigham and Women's Hospital	2017-01-06
Nasal Fentanyl for Chronic Cancer Pain NCT01906073	Withdrawn	Phase 3		Norwegian University of Science and Technology	2017-01
Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision NCT02817321	Completed	Not applicable	China	Cui Xulei	2016-11
Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain NCT02935933	Unknown status	Phase 1, Phase 2	Egypt	Assiut University	2016-10
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain NCT02741076	Terminated	Phase 4	United States	Member Companies of the Opioid PMR Consortium	2016-09-14
Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function NCT02469077	Completed	Not applicable	United States	Vanderbilt University Medical Center	2015-08
NEUROIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the Knee Joint NCT02967302	Unknown status	Phase 2, Phase 3	Germany	Hildrun Haibel	2015-08
The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy: NCT02460640	Completed	Not applicable	Italy	Regina Elena Cancer Institute	2015-05
A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain NCT02151682	Completed	Phase 2, Phase 3	Belgium, Bulgaria, Chile, France...	Grünenthal GmbH	2015-04-29
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain NCT02462577	Completed	Phase 2	Egypt	Assiut University	2015-01
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain NCT02289261	Completed	Phase 4	Turkey (Türkiye)	Cukurova University	2014-11
Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance NCT01681264	Terminated	Phase 4	United States	Massachusetts General Hospital	2014-09
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients NCT02085577	Completed	Phase 4	Denmark	Copenhagen University Hospital, Rigshospitalet	2014-05
Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds NCT02028923	Terminated	Phase 3	France	Institut Curie	2014-04
CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer NCT01964378	Terminated	Phase 3	Austria, Belgium, Bulgaria, Chile...	Tris Pharma, Inc.	2013-10-29
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects NCT01924182	Terminated	Not applicable	United States	MedtronicNeuro	2013-10
Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica NCT01914042	Unknown status	Phase 2	Israel	Rambam Health Care Campus	2013-07
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film NCT01871285	Completed	Phase 2	United States	BioDelivery Sciences International	2013-06
Methadone in Neuropathic Pain NCT01205516	Terminated	Phase 4	Canada	Nova Scotia Health Authority	2013-01
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery NCT02035904	Unknown status	Phase 4	Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	2013-01
The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain NCT02969629	Completed	Phase 4	Israel	Rambam Health Care Campus	2012-12
Perioperative Pain Management In Spine Surgery Patients: Part I NCT01447888	Completed	Not applicable	United States	Allina Health System	2011-09
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain NCT01185470	Completed	Phase 2, Phase 3	United States	Medallion Therapeutics, Inc.	2011-02
Conversion to Embeda With Rescue Trial NCT01179191	Terminated	Phase 4	United States	Pfizer	2010-08
A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants NCT01309386	Completed	Phase 3	Japan	Janssen Pharmaceutical K.K.	2010-08
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo NCT01595867	Completed	Phase 1		Pfizer	2010-08
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients NCT01100437	Terminated	Phase 4	United States	Pfizer	2010-04
A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer NCT00943566	Withdrawn	Phase 2		Labtec GmbH	2010-01
Effect of Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest NCT01037335	Withdrawn	Phase 4		The Cleveland Clinic	2009-04
Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer NCT00726830	Terminated	Not applicable	United States	M.D. Anderson Cancer Center	2009-03
Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain NCT00916890	Suspended	Phase 4	Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	2009-02
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms NCT01502644	Completed	Phase 4	United States	Brigham and Women's Hospital	2009-02
Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza NCT00640042	Completed	Phase 4	Puerto Rico, United States	Pfizer	2008-03
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine NCT00472303	Completed	Phase 3	Austria, Bulgaria, Croatia, Czechia...	Grünenthal GmbH	2007-07
Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury NCT00488969	Completed	Phase 2	United States	Icahn School of Medicine at Mount Sinai	2007-07
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine NCT00505414	Terminated	Phase 3	Argentina, Chile, France, Latvia...	Grünenthal GmbH	2007-06
Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation NCT00349401	Withdrawn	Phase 2		Wake Forest University Health Sciences	2006-12
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain NCT00415597	Completed	Phase 3	United States	Pfizer	2006-12
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee NCT00420992	Completed	Phase 3	United States	Pfizer	2006-12
Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain NCT00306020	Withdrawn	Not applicable		Soroka University Medical Center	2006-01
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine NCT00314340	Completed	Phase 4		University of California, Davis	2005-11
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients NCT00246532	Completed	Phase 4	United States	National Institute of General Medical Sciences (NIGMS)	2005-10
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain NCT01816243	Completed	Phase 4	Thailand	Janssen-Cilag Ltd.,Thailand	2004-04
Treatment for Chronic Pain in Patients With Advanced Cancer NCT00003687	Completed	Phase 3	Canada	NCIC Clinical Trials Group	1998-06-11
Efficacy of Opioids and Mexiletine for the Treatment of Postamputation Pain NCT00383682	Completed	Phase 2	United States	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1997-07

Source: openFDA drug label (US FDA), snapshot October 2026. Not a Health Canada Product Monograph.