Famotidine
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Famotidine: Duodenal obstruction
One-Sentence Summary
Famotidine is an H2 receptor antagonist originally used to treat gastric ulcer, duodenal ulcer, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. Stronger support exists for related ulcer indications such as peptic ulcer disease (8 clinical trials, 20 publications), but this largely overlaps famotidine’s approved uses and is not true repurposing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal obstruction |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known pharmacology, famotidine is a selective histamine H2 receptor antagonist. It reduces basal and stimulated gastric acid secretion, which is the basis for its use in ulcer healing and reflux disease.
Duodenogastric reflux is driven mainly by bile and duodenal contents flowing back into the stomach. Acid suppression may lessen mucosal injury from refluxed material, but it does not address the cause, so any benefit would be indirect. The two available publications are a cohort study of famotidine’s effect on gastroesophageal and duodeno-gastro-esophageal reflux in critically ill patients (2003) and a Russian-language report of famotidine 20 mg twice daily in early gastroduodenal reflux disease (2004). Both are small or old.
The other predictions fall into three groups:
- Overlap with approved uses: Peptic ulcer disease (L1, 8 trials) and active peptic ulcer disease (L1, includes randomized placebo-controlled and comparative trials) are on-label acid-related conditions.
- Plausible but weakly supported: Gastrojejunal ulcer, gastroduodenitis, and peptic ulcer perforation (all L3) rest on acid-dependence, but PPIs appear to be the preferred standard.
- Unsupported: Duodenal obstruction, abnormality of glucagon secretion, and acne have no plausible direct mechanism or no data. Multiple endocrine neoplasia has only one indirect 1986 review.
Clinical Trial Evidence
Currently no related clinical trials registered for duodenogastric reflux.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01180179 | Phase 4 | Completed | 228 | Lansoprazole vs famotidine for preventing recurrent idiopathic gastroduodenal ulcer bleeding |
| NCT00843063 | Phase 4 | Completed | 161 | High-dose famotidine vs pantoprazole for preventing recurrent aspirin-induced ulcer/erosion; famotidine was inferior |
| NCT02418312 | N/A | Completed | 228 | H2 receptor antagonist for preventing thienopyridine-related peptic ulcer |
| NCT02551744 | N/A | Completed | 101 | Pantoprazole vs famotidine for preventing recurrent ulcers in thienopyridine users |
| NCT00229424 | Phase 3 | Completed | 325 | Lafutidine vs placebo and famotidine in mild reflux oesophagitis |
| NCT03667703 | Phase 4 | Completed | 70 | Stress ulcer prophylaxis vs placebo in critically ill infants with congenital heart disease |
| NCT00557349 | Phase 4 | Completed | 40 | Zegerid vs famotidine for preventing anastomotic ulcers after gastric bypass |
| NCT00839488 | Phase 4 | Terminated | 6 | IV pantoprazole vs famotidine for stress ulcer prophylaxis after major abdominal surgery; underpowered |
Literature Evidence
Publications directly related to duodenogastric reflux:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12532466 | 2003 | Cohort/Clinical study | World J Gastroenterol | Effect of famotidine on gastroesophageal and duodeno-gastro-esophageal reflux in critically ill patients |
| 16259441 | 2004 | Clinical study (non-English) | Eksp Klin Gastroenterol | Famotidine 20 mg twice daily in early-stage gastroduodenal reflux disease |
Selected supporting literature from the related peptic ulcer predictions:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2877912 | 1987 | RCT | Gastroenterology | Placebo-controlled; nocturnal vs twice-daily famotidine in active duodenal ulcer (n=384) |
| 2570005 | 1989 | RCT | Digestion | Famotidine vs cimetidine in active duodenal ulcer (n=119) |
| 2877570 | 1986 | Multicenter randomized study | Am J Med | Famotidine vs ranitidine in active duodenal ulcer (n=1,031) |
| 19837071 | 2010 | RCT | Gastroenterology | Famotidine inferior to pantoprazole in preventing recurrence of aspirin-related ulcers or erosions |
| 31229990 | 2020 | RCT | Gut | Lansoprazole vs famotidine for preventing recurrent idiopathic ulcer bleeding |
| 22186979 | 2012 | RCT | Am J Gastroenterol | Ibuprofen/high-dose famotidine single tablet reduced gastric and duodenal ulcers vs ibuprofen alone |
| 41405382 | 2026 | Systematic review/Meta-analysis | Crit Care Med | H2RAs vs PPIs for stress ulcer prophylaxis in septic shock |
| 2573505 | 1989 | Review | Drugs | Updated review of famotidine pharmacology and therapeutic use in peptic ulcer disease |
India Market Information
Famotidine has 20 valid single-ingredient registrations, all oral tablets. The records contain no approved-indication text. Five examples:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 94049 | Famomeg 40mg Tablet (Ridhima Biocare) | Strip of 14 tablets | Not stated in records |
| 84383 | Famogreat 40mg Tablet (Mankind Pharma Ltd) | Strip of 14 tablets | Not stated in records |
| 86066 | Fadine 20mg Tablet (Aristo Pharmaceuticals Pvt Ltd) | Strip of 14 tablets | Not stated in records |
| 127423 | Litz 40mg Tablet (Glitz Pharma) | Strip of 10 tablets | Not stated in records |
| 90455 | Famopril 20mg Tablet (Zydus Cadila) | Strip of 10 tablets | Not stated in records |
Safety Considerations
- These need verification against the package insert.
- Drug Interactions: 639 interactions were found. Most listed are Moderate, for example abiraterone, acalabrutinib, tramadol, amiodarone, amitriptyline, aripiprazole, and aminophylline. Alendronic acid and aluminum hydroxide are Minor.
- Literature-noted cautions: Renal dose adjustment is needed, and CNS adverse effects such as delirium have been reported (case report, 11573854), especially in the elderly.
Please also refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: Famotidine acts on acid, whereas this condition is bile-driven, so benefit would be indirect. The L1 evidence applies to peptic ulcer disease, which overlaps famotidine’s approved uses and is not true repurposing. In that setting famotidine was inferior to PPIs for preventing aspirin-related ulcer recurrence.
To proceed, the following is needed:
- A prospective, controlled study of famotidine in duodenogastric reflux, with bile-reflux endpoints
- Detailed mechanism-of-action data
- Package insert warnings and contraindications from the India regulator
- A comparison against PPIs, and a dosing plan covering renal impairment and elderly patients
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.