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Acetaminophen/Codeine
Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid that binds to opioid receptors to provide additional analgesic and antitussive effects.
Acetaminophen reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, while codeine is an opioid agonist that binds to mu opioid receptors to provide additional analgesic and antitussive effects. Used for Moderate pain management, Cough suppression.
At a glance
| Generic name | Acetaminophen/Codeine |
|---|---|
| Also known as | Tylenol 3 |
| Sponsor | University of Pennsylvania |
| Drug class | Opioid analgesic combination |
| Target | Mu opioid receptor (codeine); COX enzymes (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Acetaminophen's exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis in the central nervous system and modulation of serotonergic and noradrenergic pathways. Codeine is a weak opioid agonist that binds to mu, delta, and kappa opioid receptors in the brain and spinal cord, enhancing pain relief and suppressing cough reflex. The combination provides synergistic analgesia for moderate pain.
Approved indications
- Moderate acute pain
- Moderate chronic pain
- Cough suppression
Common side effects
- Drowsiness
- Dizziness
- Constipation
- Nausea
- Respiratory depression
- Dependence/addiction risk
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304) (PHASE2)
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1, PHASE2)
- Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy (PHASE2, PHASE3)
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Opioid-Sparing Joint Replacement (PHASE3)
- Reduced Opioid Prescription After Laparoscopic Hysterectomy (NA)
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 CI brief — competitive landscape report
- Acetaminophen/Codeine updates RSS · CI watch RSS
- University of Pennsylvania portfolio CI