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Codeine/acetaminophen
Codeine is converted to morphine in the body to activate opioid receptors for pain relief, while acetaminophen inhibits prostaglandin synthesis to reduce pain and fever.
Codeine is converted to morphine in the body to activate opioid receptors for pain relief, while acetaminophen inhibits prostaglandin synthesis to reduce pain and fever. Used for Moderate acute pain, Moderate chronic pain.
At a glance
| Generic name | Codeine/acetaminophen |
|---|---|
| Also known as | Tylenol with codeine |
| Sponsor | Montefiore Medical Center |
| 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
Codeine is a prodrug opioid agonist that undergoes hepatic metabolism (primarily via CYP2D6) to morphine, which binds mu-opioid receptors in the central nervous system to produce analgesia. Acetaminophen works through a separate mechanism by inhibiting cyclooxygenase (COX) enzymes and reducing prostaglandin production, providing additional analgesic and antipyretic effects. The combination provides synergistic pain relief for moderate pain.
Approved indications
- Moderate acute pain
- Moderate chronic pain
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Vomiting
- Hepatotoxicity (acetaminophen)
- Respiratory depression
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:
- Codeine/acetaminophen CI brief — competitive landscape report
- Codeine/acetaminophen updates RSS · CI watch RSS
- Montefiore Medical Center portfolio CI