Codeine
| Evidence Level: L4 | Predicted Indications: 4 |
Table of Contents
Codeine: From Opioid Analgesia to Nasal Cavity Disease
One-Sentence Summary
Codeine is an opioid medicine that is widely marketed in South Africa, generally used for pain and cough relief. The TxGNN model predicts it may be relevant to nasal cavity disease, but there are 0 clinical trials and only 2 publications, both case reports of nasal harm from opioid misuse rather than treatment benefit. This prediction should not be pursued as a therapeutic candidate.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration records provided (codeine is generally used for mild-to-moderate pain and cough) |
| Predicted New Indication | Nasal cavity disease |
| TxGNN Prediction Score | 99.93% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this record. Codeine is known to be an opioid analgesic and antitussive, but no mechanistic pathway linking it to a therapeutic effect in the nasal cavity can be established from the data provided.
The high model score is not backed by therapeutic evidence. Both publications describe harm rather than benefit. One reports tissue necrosis of the nasal cavity and pharynx after snorting a crushed opioid tablet (hydrocodone-acetaminophen). The other reports a rhinolith (a stone in the nose) that formed around a hardened codeine-and-opium mixture. This is a misuse or adverse-effect association, not a treatment signal. The graph model has most likely linked codeine to the nasal cavity because of these co-occurrences.
The lower-ranked predictions in this pack show the same pattern. For acute laryngopharyngitis there is no evidence at all, and symptomatic cough relief is only a speculative link. For allergic urticaria, the literature shows codeine causing urticaria by directly triggering mast cells, which is the opposite of a therapeutic use.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 22965281 | 2012 | Case report | The Laryngoscope | Necrosis of the nasal cavity and pharynx after intranasal abuse of hydrocodone-acetaminophen tablets. This is a harm signal, and the drug involved is not codeine. |
| 17315836 | 2007 | Case report | Ear, Nose & Throat Journal | Unilateral rhinolith formed around a hardened codeine-and-opium mixture (“opioma”) in a 21-year-old man. This is a foreign-body case, not a treatment. |
South Africa Market Information
Registrations are listed with the fields available; approved indication text was not provided in the records.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| S/2.8/137 | Empacod | Tablet | Not provided |
| B 1006 (ACT 101) | Omnopon 1ml Fresenius 20 | Injection | Not provided |
| B1192 (ACT 101) | Codeine phos | Tablet | Not provided |
| X/2.8/109 | Cogesic | Tablet | Not provided |
| G1260 (ACT101) | Codomil new formula | Syrup | Not provided |
Showing 5 of 20 registrations. Other registered forms include capsules and suspensions.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on model output alone. The only literature describes nasal injury from opioid misuse and a foreign-body case, not benefit. No trials exist and no plausible mechanism can be established.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data for codeine (for example from DrugBank)
- Any evidence of therapeutic benefit in nasal cavity disease, such as controlled or observational studies; the current publications do not qualify
- Clarification of the intended route and formulation for a nasal indication, since none is defined
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.