Ranitidine
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Ranitidine: From Acid-Related Disorders to Active Peptic Ulcer Disease
One-Sentence Summary
Ranitidine is an H2-receptor antagonist that reduces gastric acid secretion. The SAHPRA data supplied do not state an approved indication. The TxGNN model predicts it may be effective for active peptic ulcer disease, but this is effectively a known use of the drug rather than a new one. Evidence includes 1 registered clinical trial (not relevant to ranitidine) and 19 retrieved publications, of which only a subset directly studies ranitidine.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA data supplied (acid-related conditions are assumed from the drug class) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L3 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 2 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on known pharmacology, ranitidine is a histamine H2-receptor antagonist. It blocks histamine at the parietal cell and so lowers gastric acid output. Acid suppression is the established basis for healing peptic ulcers.
The prediction is biologically sound, but it is not a true repurposing signal. Peptic ulcer disease is a recognised, long-standing use of ranitidine. The model probably reports it as “new” because the original indication and mechanism fields are empty in the source data, not because the link is novel.
Ranitidine was withdrawn or restricted in many markets from 2019-2020 over NDMA contamination. The “Marketed” status in South Africa should therefore be verified with SAHPRA before any planning.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00930670 | Phase 4 | Completed | 320 | Effect of statins and proton pump inhibitors on clopidogrel antiplatelet response after PCI. Ranitidine and ulcer treatment were not tested, so this gives no direct evidence. |
No SANCTR or PACTR registrations were identified.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3104657 | 1986 | RCT | Klin Wochenschr | Nocturnal rioprostil compared with ranitidine for duodenal ulcer healing |
| 2491360 | 1989 | Randomised double-blind trial | J Gastroenterol Hepatol | 270 patients with active duodenal ulcer: omeprazole 10 or 20 mg vs ranitidine 150 mg twice daily, with weekly endoscopy for healing and relapse |
| 2877570 | 1986 | Randomised double-blind trial | Am J Med | 1,031 patients from 19 countries with active duodenal ulcer: famotidine vs ranitidine |
| 1863945 | 1991 | Randomised trial | Clin Ther | 160 patients: 8-week duodenal ulcer healing was 94% with famotidine vs 80% with ranitidine; maintenance therapy followed for 6 months |
| 2092029 | 1990 | Randomised double-blind trial | J Assoc Physicians India | 40 patients with gastric or duodenal ulcer: famotidine 40 mg vs ranitidine 300 mg at night for 4-8 weeks |
| 3909374 | 1985 | Clinical series (classified Review) | Scand J Gastroenterol | Ranitidine 300 mg daily: 4-week healing was 91% (duodenal), 68% (prepyloric) and 81% (gastric corporeal); maintenance therapy was tested against placebo |
| 2667937 | 1989 | Review | Drugs | Ranitidine 300 mg daily is at least as effective as cimetidine for ulcer healing |
| 6128216 | 1982 | Review | Drugs | Ranitidine 150 mg twice daily is an effective alternative to cimetidine for duodenal and gastric ulcer healing |
| 8791962 | 1996 | Clinical study | Aliment Pharmacol Ther | High-dose ranitidine to prevent recurrent ulcers in NSAID-treated rheumatoid arthritis patients; low-dose ranitidine works for duodenal but not gastric ulcer |
| 12749277 | 2003 | Controlled study | Hepato-gastroenterology | Ulcer relapse prevention with ranitidine plus ecabet vs ranitidine alone, independent of H. pylori eradication |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 32/11.4.3/0142 | Histak 150 Tables | Tablet (oral) | Not stated in supplied data |
| A39/11.4.3/0391 | Austac-75 | Tablet (oral) | Not stated in supplied data |
Essential Medicines List (EML) inclusion was not confirmed from the supplied data.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA. No drug interactions were found in the queried data.
Conclusion and Next Steps
Decision: Hold
Rationale:
- Peptic ulcer disease is a well-established use of ranitidine, so this is not a novel repurposing finding. The supporting literature is largely 1980s-1990s H2-blocker trials, and no relevant registered trial was found.
- The NDMA-related withdrawals in other markets mean local availability and safety status must be checked first.
- Other predictions are weaker. Peptic ulcer disease (rank 7) duplicates this entry. Perforated peptic ulcer, gastrojejunal ulcer and gastroduodenitis have little or no direct evidence. Duodenogastric reflux, duodenal obstruction, glucagon secretion abnormality and the mastocytosis entries rest on the model prediction alone, with at most symptomatic plausibility.
To proceed, the following is needed:
- Confirmation from SAHPRA of the current registration status of Histak 150 and Austac-75, including any NDMA-related actions
- The SAHPRA-approved Professional Information (approved indications, warnings, contraindications, interactions)
- Mechanism of action data from DrugBank
- Full-text review of the controlled ulcer-healing trials to confirm the evidence level
- Confirmation of EML status and place in South African ulcer guidelines
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.