Last reviewed · How we verify
DIHYDROCODEINE BITARTRATE
At a glance
| Generic name | DIHYDROCODEINE BITARTRATE |
|---|---|
| Drug class | Central Nervous System Stimulant [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1983 |
Approved indications
Boxed warnings
- WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
Common side effects
- Light-headedness
- Dizziness
- Drowsiness
- Headache
- Fatigue
- Sedation
- Sweating
- Nausea
- Vomiting
- Constipation
- Pruritus
- Skin reactions
Serious adverse events
- Hepatoxicity
- Hypersensitivity reactions/Anaphylactoid reactions
- Hallucinations
- Granulomatous interstitial nephritis
- Acute renal failure
- Severe narcosis
- Agranulocytosis
- Thrombocytopenia
- Pancytopenia
- Angioedema
Key clinical trials
- Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments. (NA)
- Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain (PHASE4)
- A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs). (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- DIHYDROCODEINE BITARTRATE CI brief — competitive landscape report
- DIHYDROCODEINE BITARTRATE updates RSS · CI watch RSS