Gentamicin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Gentamicin: From Bacterial Infections to Rheumatoid Arthritis
One-Sentence Summary
Gentamicin is an aminoglycoside antibiotic marketed in Singapore as injections, creams, eye drops and eye ointment. The TxGNN model predicts it may be effective for Rheumatoid Arthritis, but there are 0 clinical trials and no publications showing that gentamicin treats this disease. The retrieved papers mention rheumatoid arthritis only incidentally, so this is a model-only prediction and the recommendation is Hold.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the Singapore licence records contain no approved indication text) |
| Predicted New Indication | Rheumatoid arthritis |
| TxGNN Prediction Score | 97.76% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available from the compiled data. Gentamicin is known to be an aminoglycoside antibiotic that inhibits protein synthesis by binding the bacterial 30S ribosomal subunit. It is used to treat bacterial infections.
This mechanism has no credible link to rheumatoid arthritis. Gentamicin has no known immunomodulatory activity relevant to the disease. In the retrieved literature, rheumatoid arthritis appears only as background, for example in patients who developed infections while on immunosuppressive treatment. Gentamicin is used there as an antibacterial for the infection, not as a disease-modifying treatment. The high TxGNN score (0.978) is a computational prediction without clinical support.
Other predicted indications were also reviewed. None has direct clinical support:
- Sclerosing cholangitis: Oral vancomycin plus gentamicin has been reported in very early onset inflammatory bowel disease, suggesting a possible gut-microbiome rationale. There is no direct evidence in sclerosing cholangitis itself (evidence level L4).
- Diabetic nephropathy: Gentamicin is nephrotoxic, so this prediction is mechanistically doubtful.
- Other predictions (rare genetic syndromes, osteoarthritis susceptibility, myelodysplastic syndrome, and others): no supporting trials or relevant studies.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the retrieved papers tests gentamicin as a treatment for rheumatoid arthritis. The table lists the most relevant ones; the first three are case reports or reviews, and the rest are preclinical or pharmacokinetic papers.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 33827581 | 2021 | Case report | Ann Clin Microbiol Antimicrob | Helicobacter canis bacteraemia in an RA patient treated with tofacitinib; infection case, not RA treatment |
| 40293759 | 2025 | Review | JAMA | Review of non-cystic fibrosis bronchiectasis in adults; not related to gentamicin treating RA |
| 41221316 | 2025 | Review | Acta Ortop Bras | Infection risk factors, prevention and treatment after total hip arthroplasty |
| 42618450 | 2026 | Preclinical/Mechanistic | Gut | Intestinal flagellin drives multisystem inflammation; RA mentioned as one example of systemic inflammatory disease |
| 7019786 | 1981 | Case report | N Z Med J | Acute tubular necrosis in an RA patient after gentamicin and cefoxitin; a safety signal |
| 32751547 | 2020 | Preclinical (rat) | Pharmaceutics | Tofacitinib elimination is slower in gentamicin-induced renal failure rats |
| 33812255 | 2021 | Preclinical (mouse) | Int Immunopharmacol | Daphnetin reduced gentamicin-induced kidney injury; gentamicin used as a toxicity model |
| 2487744 | 1989 | Case report | Medicina | Anaerobic meningitis in an RA patient on intensive treatment |
| 36074653 | 2023 | Case report | Ocul Immunol Inflamm | Orbital cellulitis in a patient with a history of RA |
| 42291967 | 2026 | Case report | Cureus | S. aureus spondylodiscitis in an RA patient receiving rituximab |
Singapore Market Information
Gentamicin has 20 valid single-ingredient registrations in Singapore (no cancelled licences). Forms include cream, injection, eye drops (solution) and eye ointment. The licence records contain no approved indication text. The table lists five of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN05260P | Gentamicin Injection BP 80 mg/2 ml (Pfizer) | Injection | Not stated in licence record |
| SIN09941P | Gentamicin Injection 80 mg/2 ml (Shin Poong) | Injection | Not stated in licence record |
| SIN01544P | Gentamicin Sulfate Cream 1 mg/g | Cream | Not stated in licence record |
| SIN09799P | Gentamicin-POS Eye Drops 3 mg/ml | Solution | Not stated in licence record |
| SIN09755P | Dexa-Gentamicin Eye Ointment | Ointment | Not stated in licence record |
Safety Considerations
- Drug Interactions: The interaction query returned 100 records. Those shown are from the DDInter database. Major-level interactions include:
- Agalsidase beta
- Magnesium sulfate
- Mannitol
Moderate-level interactions include:
- Other aminoglycosides and nephrotoxic or ototoxic antibiotics (kanamycin, neomycin, vancomycin)
- Amphotericin B
- Aspirin
- Proton pump inhibitors (omeprazole, pantoprazole, lansoprazole and others)
- Aminosalicylates (mesalazine, sulfasalazine, balsalazide, olsalazine)
- Picosulfuric acid
- Literature safety signals: The retrieved papers describe gentamicin-related nephrotoxicity and vestibulotoxicity (vestibular and balance damage). These are particularly relevant to kidney-related predictions such as diabetic nephropathy.
Please refer to the package insert for formal warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials, no supportive studies, and no plausible mechanism linking an antibacterial aminoglycoside to rheumatoid arthritis. Gentamicin's known nephrotoxicity and ototoxicity add further concern.
To proceed, the following is needed:
- A credible mechanistic hypothesis, and mechanism of action data from DrugBank
- Preclinical evidence in RA models showing a benefit beyond antibacterial activity
- Package insert warnings and contraindications from the HSA, to allow safety screening
- Confirmation of the approved indications for the Singapore licences
- If the sclerosing cholangitis direction is of interest, it would be better to start with a focused review of antibiotic and gut-microbiome evidence in that disease
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.