Last reviewed · How we verify
Norco
At a glance
| Generic name | Norco |
|---|---|
| Also known as | Hydrocodone-Acetaminophen combination medication, hydrocodone bitartrate/ acetaminophen, Hydrocodone/Acetaminophen, Narcotic |
| Sponsor | The University of Texas Health Science Center, Houston |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdo
Common side effects
- Light-headedness
- Dizziness
- Sedation
- Nausea
- Vomiting
- Drowsiness
- Mental clouding
- Lethargy
- Impairment of mental and physical performance
- Anxiety
- Fear
- Dysphoria
Serious adverse events
- Serotonin syndrome
- Adrenal insufficiency
- Anaphylaxis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Hearing impairment
- Permanent hearing loss
- Thrombocytopenia
- Agranulocytosis
- Androgen deficiency
Key clinical trials
- Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2, PHASE3)
- The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery (NA)
- The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery in Gynecologic Oncology (NA)
- A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery (NA)
- The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery (NA)
- Post-operative Pain Management in Children With Supracondylar Humerus Fractures (PHASE4)
- Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery (PHASE4)
- SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management (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:
- Norco CI brief — competitive landscape report
- Norco updates RSS · CI watch RSS
- The University of Texas Health Science Center, Houston portfolio CI