Tramadol hydrochloride extended-release capsules: 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 Tramadol hydrochloride extended-release capsules is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Tramadol hydrochloride extended-release capsules is an opioid agonist indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Seizures: Can occur within the recommended dose range. Concomitant use with certain other drugs may increase the seizure risk. Risk of convulsions may increase in patients with epilepsy, history of seizures, and with a recognized risk for seizure ( 5.1 , 5.9 ). Suicide: Do not prescribe for suicidal or addiction-prone patients ( 5.2 ). Serotonin Syndrome: May be life-threatening. Can occur with tramadol alone or with concomitant use of other serotonergic drugs or those that inhibit metabolism of tramadol (5.3. 5.9). Anaphylactoid Reactions: Serious and rarely fatal anaphylactoid reactions have occurred. Increased risk in patients with history of anaphylactoid reactions to other opioids ( 5.4 ). Hypersensitivity reactions: Serious and rarely fatal anaphylactoid reactions have occurred, often after the first dose. Other reactions include pruritus, hives, bronchospasm, angioedema, TEN, SJS. ( 5.4 ) Respiratory Depression: Administer cautiously in patients at ris…

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. A match on the drug name does not mean the trial studied this specific product.

29 trials, recruiting first

		Phase	Countries
Erector Spinae Plane Block for Chronic Pain After Spinal Surgery NCT07834502	Not yet recruiting	Not applicable	Turkey (Türkiye)	Aydin Adnan Menderes University	2026-10-01
Comparison of Two Postoperative Care Strategies After Breast Surgery NCT07880223	Not yet recruiting	Not applicable	Greece	Moumtzidou Maria Aikaterini	2026-10
EOIB for Laparoscopic Cholecystectomy NCT06656299	Recruiting	Not applicable	Turkey (Türkiye)	Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital	2024-10-30
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow NCT06373978	Recruiting	Phase 4	United States	The Cleveland Clinic	2024-08-12
Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain NCT05125978	Withdrawn	Phase 2		EMS	2026-09
Tapentadol vs Tramadol in Arthroscopic Rotator Cuff Repair NCT07779473	Active, not recruiting		Greece	University of Thessaly	2026-07-01
Tapentadol vs Tramadol in Total Knee Arthroplasty NCT06269770	Unknown status	Phase 4	Greece	University of Thessaly	2023-05-01
Tapentadol Versus Tramadol Analgesia Post Cardiac Surgery NCT04718116	Unknown status	Not applicable	Greece	Aretaieion University Hospital	2022-11-01
Efficacy of Duloxetine in Conjunction With Tramadol for Chronic Cancer Pain NCT05311774	Completed	Not applicable	Egypt	Assiut University	2022-04-01
Pain Multidisciplinar Intervention in Major Trauma Patients NCT05355441	Completed		Spain	Nuria Llorach-Perucho	2022-04-01
Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain NCT04589494	Unknown status	Phase 2, Phase 3	Egypt	Assiut University	2020-04-16
Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain NCT02722603	Terminated	Phase 3	Germany, Netherlands	Pharmaceutical Research Management srl	2018-09-12
Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study NCT03494426	Completed	Not applicable	Egypt	Assiut University	2018-04-01
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma NCT03255330	Withdrawn	Phase 3	Czechia	Masaryk University	2017-10
A Phase 3 Study of Tanezumab for Chronic Low Back Pain NCT02528253	Completed	Phase 3	Canada, Denmark, France, Hungary...	Pfizer	2015-08-18
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? NCT02307305	Unknown status	Phase 2	South Korea	Hanyang University Seoul Hospital	2014-08
An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain NCT01112267	Completed	Phase 3		Janssen Korea, Ltd., Korea	2009-05
An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain NCT00736853	Completed	Phase 3	Japan	Janssen Pharmaceutical K.K.	2008-06
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain NCT00736957	Completed	Phase 3	Japan	Janssen Pharmaceutical K.K.	2008-05
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain NCT00662558	Completed	Phase 3	United States	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	2008-01
Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics NCT00505531	Terminated		United States	Massachusetts General Hospital	2007-06
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine NCT00426647	Completed	Phase 4	Finland	Norpharma A/S	2007-02
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. NCT00290901	Completed	Phase 4	Puerto Rico, United States	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	2006-03
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain NCT01968018	Completed	Phase 4	Thailand	Janssen-Cilag Ltd.,Thailand	2004-07
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA) NCT00348452	Completed	Phase 3		Bausch Health Americas, Inc.	2002-09
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip NCT00325858	Completed	Phase 3	United States	Bausch Health Americas, Inc.	2002-01
A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain NCT00347724	Completed	Phase 3		Bausch Health Americas, Inc.	2000-11
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee NCT00348010	Completed	Phase 3		Bausch Health Americas, Inc.	2000-11
A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain. NCT00347685	Completed	Phase 3	United States	Bausch Health Americas, Inc.	2000-10

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