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Ultracet®
Ultracet combines tramadol (an opioid agonist and monoamine reuptake inhibitor) with acetaminophen to provide enhanced pain relief through dual analgesic pathways.
Ultracet combines tramadol (an opioid agonist and monoamine reuptake inhibitor) with acetaminophen to provide enhanced pain relief through dual analgesic pathways. Used for Moderate acute pain in adults.
At a glance
| Generic name | Ultracet® |
|---|---|
| Also known as | Tramadol/APAP, Tramadol APAP |
| Sponsor | Labopharm Inc. |
| Drug class | Opioid analgesic combination |
| Target | Mu-opioid receptor; norepinephrine and serotonin transporters; COX enzymes |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Tramadol acts as a weak mu-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin, enhancing descending pain inhibitory pathways. Acetaminophen works through unclear mechanisms involving central COX inhibition and endocannabinoid pathways. Together, these agents provide synergistic analgesia for moderate pain.
Approved indications
- Moderate acute pain in adults
Common side effects
- Dizziness
- Nausea
- Constipation
- Headache
- Somnolence
- Vomiting
- Pruritus
Key clinical trials
- Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination (PHASE1)
- An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) (PHASE4)
- A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers (PHASE1)
- A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery (PHASE4)
- A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain (PHASE4)
- A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache (PHASE4)
- An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients (PHASE4)
- Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis (PHASE4)
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 |
|---|---|
| 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:
- Ultracet® CI brief — competitive landscape report
- Ultracet® updates RSS · CI watch RSS
- Labopharm Inc. portfolio CI