Cimetidine
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Cimetidine: Histamine H2-receptor antagonist → peptic ulcer perforation
One-Sentence Summary
Cimetidine is a histamine H2-receptor antagonist that reduces stomach acid. The TxGNN model predicts it may be relevant for peptic ulcer perforation, but no clinical trials are registered and the 20 publications compiled for this report are mostly case reports, reviews and observational analyses. Several of them describe perforation occurring while patients were taking cimetidine.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | peptic ulcer perforation |
| TxGNN Prediction Score | 0.9977 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (8 of 8) – CDSCO approval status is not included in this data |
| Number of Listed Products | 8 (valid: 8) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Cimetidine belongs to the H2-receptor antagonist class, which lowers gastric acid secretion. In principle, acid suppression could support healing of the ulcer that underlies a perforation.
However, perforation is an acute surgical emergency, and acid suppression is not a treatment for it. Several reports in the literature describe perforation occurring while patients were already on cimetidine (PMIDs 3967139, 6743974, 7082957). This argues against efficacy in preventing or treating this complication. The high model score most likely reflects the general association between cimetidine and peptic ulcer disease rather than a true therapeutic signal.
No cited study tests cimetidine as a treatment for peptic ulcer perforation. The evidence level is therefore L5.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8364140 | 1993 | Review of controlled trials | Aliment Pharmacol Ther | Continuous H2-antagonist therapy reduces ulcer recurrence; relapse rates vary with study design |
| 6113521 | 1981 | Review | Lancet | Overview of cimetidine and peptic ulcer |
| 3967139 | 1985 | Case report | Br J Surg | Perforation occurring while on cimetidine |
| 6743974 | 1984 | Case report | Br J Surg | Nine duodenal ulcer perforations on cimetidine; all eventually needed truncal vagotomy and drainage |
| 7082957 | 1982 | Hospital review/letter | Br J Surg | After cimetidine became available, elective ulcer operations fell 45%, perforations only about 10% |
| 6649737 | 1983 | Observational analysis | Z Gastroenterol | Operations for ulcer fell 35% after cimetidine; fewer elective cases, with a smaller decrease in complicated ulcers |
| 6861858 | 1983 | Observational analysis | Eur J Clin Pharmacol | Peptic-ulcer-related discharges were about 10% lower once cimetidine was widely available |
| 1975090 | 1990 | Review | Minerva Chir | Ulcer therapy before and after cimetidine; surgical outcomes |
| 6150640 | 1984 | Review | Am J Med | Hospitalizations for duodenal ulcer fell, but perforation incidence did not change significantly |
| 922364 | 1977 | Report | Br Med J | Perforation of peptic ulcer after withdrawal of cimetidine |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 231297 | Ulciban 400mg Tablet | Strip of 10 tablets | Not recorded |
| 223407 | Tagasec 200mg Tablet | Strip of 10 tablets | Not recorded |
| 43394 | Cimetiget 200mg Tablet | Strip of 10 tablets | Not recorded |
| 155392 | Neotid 400mg Tablet | Strip of 10 tablets | Not recorded |
| 39684 | Cimetiget 400mg Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
- Disease-related cautions (not label text): The data compiled for this report flag liver disease, gallbladder disease, impaired renal function and gastric cancers (including gastric carcinoma and gastric neoplasm) as conditions of concern.
- Drug Interactions: 551 interactions are recorded. Examples at moderate level include paclitaxel, fentanyl, acalabrutinib, lidocaine, acebutolol, dihydrocodeine, codeine, tramadol, nifedipine and alfentanil. Minor-level examples include dolutegravir, zidovudine, acetaminophen, ibuprofen and ethanol.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: No clinical trial or study directly supports cimetidine for peptic ulcer perforation. Case reports show perforation occurring during cimetidine therapy, so the prediction looks like an artifact of the drug’s link to ulcer disease.
To proceed, the following is needed:
- Direct clinical evidence in perforated ulcer, such as controlled studies of post-operative or conservative management
- Mechanism of action data
- Package insert warnings and contraindications from the Indian regulatory source
- A review of the interaction profile for likely co-medications
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.