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acetaminophen/codeine and ibuprofen
acetaminophen/codeine and ibuprofen is a Combination analgesic (opioid + NSAID + acetaminophen) Small molecule drug developed by University of California, Davis. It is currently FDA-approved for Moderate pain. Also known as: Tylenol-Codeine No. 3, Advil.
This combination product uses acetaminophen and codeine for pain relief via different pathways, while ibuprofen provides additional anti-inflammatory and analgesic effects.
This combination product uses acetaminophen and codeine for pain relief via different pathways, while ibuprofen provides additional anti-inflammatory and analgesic effects. Used for Moderate pain.
At a glance
| Generic name | acetaminophen/codeine and ibuprofen |
|---|---|
| Also known as | Tylenol-Codeine No. 3, Advil |
| Sponsor | University of California, Davis |
| Drug class | Combination analgesic (opioid + NSAID + acetaminophen) |
| Target | Mu opioid receptor (codeine); COX-1/COX-2 (ibuprofen); unclear (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Acetaminophen works as a centrally-acting analgesic and antipyretic through unclear mechanisms possibly involving serotonergic and cannabinoid pathways. Codeine is an opioid agonist that binds mu opioid receptors to reduce pain perception. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, providing analgesia and anti-inflammatory effects.
Approved indications
- Moderate pain
Common side effects
- Nausea
- Dizziness
- Constipation
- Gastrointestinal upset
- Drowsiness
Key clinical trials
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial (PHASE2)
- Opioid Use After Laparoscopic Salpingectomy (PHASE4)
- Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction (PHASE1)
- Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures (PHASE4)
- Supracondylar Post-Operative Pain Study (PHASE4)
- ICE-T Pain Regimen for Total Laparoscopic Hysterectomy (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:
- acetaminophen/codeine and ibuprofen CI brief — competitive landscape report
- acetaminophen/codeine and ibuprofen updates RSS · CI watch RSS
- University of California, Davis portfolio CI
Frequently asked questions about acetaminophen/codeine and ibuprofen
What is acetaminophen/codeine and ibuprofen?
How does acetaminophen/codeine and ibuprofen work?
What is acetaminophen/codeine and ibuprofen used for?
Who makes acetaminophen/codeine and ibuprofen?
Is acetaminophen/codeine and ibuprofen also known as anything else?
What drug class is acetaminophen/codeine and ibuprofen in?
What development phase is acetaminophen/codeine and ibuprofen in?
What are the side effects of acetaminophen/codeine and ibuprofen?
What does acetaminophen/codeine and ibuprofen target?
Related
- Drug class: All Combination analgesic (opioid + NSAID + acetaminophen) drugs
- Target: All drugs targeting Mu opioid receptor (codeine); COX-1/COX-2 (ibuprofen); unclear (acetaminophen)
- Manufacturer: University of California, Davis — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate pain
- Also known as: Tylenol-Codeine No. 3, Advil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing