TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (acetaminophen)
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options (e.g.
Details
- Status
- Discontinued
- First Approved
- 2005-04-21
- Routes
- ORAL
- Dosage Forms
- TABLET
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Approval History
What TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Treats
11 FDA approvalsOriginally approved for its first indication in 2005 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Apr 2005)Letter
- • Approved indication (Dec 2005)
- • Approved indication (Jul 2006)
- • Approved indication (Sep 2008)Letter
- • Approved indication (Dec 2009)
- • Approved indication (Mar 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Apr 2014)
- • Approved indication (Mar 2017)
- • Approved indication (May 2017)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN Addiction, Abuse, and Misuse Because the use of tramadol hydrochloride and acetaminophen exposes 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 (5.1) ]. Life-Threatening Respi...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN Addiction, Abuse, and Misuse Because the use of tramadol hydrochloride and acetaminophen exposes 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 (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol hydrochloride and acetaminophen, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride and acetaminophen are essential [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of tramadol hydrochloride and acetaminophen, especially by children, can result in a fatal overdose of tramadol [see Warnings and Precautions (5.2) ]. 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 tramadol hydrochloride and acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. NeonatalOpioidWithdrawal 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 (5.4) ]. Opioid Analgesic Risk Evaluation and Mitigation St
Clinical Trial Registry
253 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04165096 results posted | 3475-01C MK-3475-01C, KEYMAKER-U01C | Ph 2 | completed | KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C) |
| NCT06009926 | NCI-2023-06404 NCI-2023-06404, STUDY00003544 | Ph 2 | active not recruiting | Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters |
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT05878015 | 23-000547 | Ph 4 | enrolling by invitation | A Study of Intravenous Acetaminophen for Small Bowel Obstruction |
| NCT07567924 | SIUT-ERC-2024/A-475 | Ph 4 | completed | Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome |
| NCT04221477 REGENCY results posted | CA41705 2019-004034-42, 2023-503628-22-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis |
| NCT06043323 | 2023-0087 NCI-2023-07173 | Ph 2 | recruiting | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma |
| NCT07571252 | 2603555595 | Ph 4 | not yet recruiting | Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery |
| NCT06762600 | HRS-4729-101 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects |
| NCT07525791 | NN9662-8158 U1111-1328-3457 | Ph 1 | recruiting | A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight |
| NCT07508241 | C6491010 MET097-25-106 | Ph 1 | recruiting | A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity |
| NCT07525219 | IRB00146434 | Ph 3 | not yet recruiting | Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen |
| NCT03823534 | 28927 | Ph 3 | recruiting | Post-Op Pain Control for Prophylactic Intramedullary Nailing. |
| NCT05722002 CARES | HUM00215416 CER-2021C1-22398 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial |
| NCT05285813 | 2021-1124 NCI-2022-02215 | Ph 2 | terminated | A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure |
| NCT03759028 | IRB# 18-001158 | Ph 4 | recruiting | Supracondylar Post-Operative Pain Study |
| NCT04629248 MAJESTY | WA41937 2020-003233-38, 2023-506525-11-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy |
| NCT06214468 | 23-067/2026659-2 | Ph 1 | completed | Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity |
| NCT06187584 results posted | STUDY00000286 | Ph 4 | completed | Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management |
| NCT07502001 | HDM1005-104 | Ph 1 | not yet recruiting | Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin |
| NCT04268498 ADVANCE | 20201316 2019-001645-41, 19-339 | Ph 2 | active not recruiting | A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma |
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| NCT03258593 results posted | 170157 17-C-0157 | Ph 1 | completed | Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) |
| NCT04459117 TREOCAPA | C19-29 2019-004297-26 | Ph 2, Ph 3 | completed | Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen |
| NCT05896228 Iber-KDd | 20230227 | Ph 2 | recruiting | Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma |
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05597878 | IRB00091354 P30CA012197, WFBCCC 01122 | Ph 2, Ph 3 | terminated | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy |
| NCT06671002 CARES for Kids | HUM00252793 BPS-2023C1-32147 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial |
| NCT03974932 results posted | HTX-011-306 | Ph 3 | completed | Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen |
| NCT03695367 results posted | HTX-011-215 | Ph 2 | completed | Phase 2 Herniorrhaphy Study for Opioid Elimination |
| NCT07429032 | 20230012 | Ph 1 | completed | The Effect of AMG 133 on Gastric Emptying |
| NCT06356571 SubQSA | LPS18183 U1111-1298-7348 | Ph 2 | recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT04224558 | Pro00051458 | Ph 1, Ph 2 | recruiting | Stem Cell Transplantation in Crohn's Disease |
| NCT06994442 OPTICOM | 24-12028276 U01HD116260 | Ph 3 | recruiting | Optimizing Pain Treatment in Children On Mechanical Ventilation |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT05488847 results posted | 15592 | Ph 4 | active not recruiting | Opioid-Free Pain Protocol After Shoulder Arthroplasty |
| NCT07101445 | STUDY00008909 NCI-2025-03018, STUDY00008909 | Ph 4 | recruiting | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial |
| NCT05640674 results posted | 52475 | Ph 4 | terminated | Post-operative Pain Management in Children With Supracondylar Humerus Fractures |
| NCT04918147 results posted | DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 | Ph 2 | terminated | Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
| NCT01391962 results posted | 110200 11-C-0200 | Ph 2 | completed | Sunitinib or Cediranib for Alveolar Soft Part Sarcoma |
| NCT04681105 | 20472 NCI-2020-08118, 20472 | Ph 1 | completed | Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies |
| NCT06997016 | Baylor IRB #025-220 | Ph 4 | enrolling by invitation | Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients |
| NCT02797522 results posted | ARC5211001 | Ph 1 | terminated | A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) |
| NCT05211336 results posted | 10000516 000516-C | Ph 1 | active not recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System |
| NCT03978767 PANDA | 201901202 | Ph 2 | completed | Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial |
| NCT05704049 IZALCO | ACT17453 U1111-1280-5090, 2023-508870-27 | Ph 2 | active not recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT05603832 | 100-CIP02-P | Ph 3 | completed | A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement |
| NCT04270409 | EFC15992 U1111-1222-7068, 2023-507419-37 | Ph 3 | active not recruiting | Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma |
| NCT03997851 results posted | 20190133 | Ph 1, Ph 2 | completed | Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects |
| NCT05035407 results posted | 10000045 000045-C | Ph 1 | terminated | T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers |
Showing 50 of 253 trials
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.
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN FDA Label Details
Indications & Usage
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Tramadol hydrochlorideandacetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analges...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN Addiction, Abuse, and Misuse Because the use of tramadol hydrochloride and acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.