Potassium Iodide

Evidence Level: L4

Predicted Indications: 2

Potassium Iodide
1. Pharmacist Assessment Report
Potassium Iodide: From Allergic Rhinitis and Upper Respiratory Conditions to Nasal Cavity Disease

Pharmacist Assessment Report

Potassium Iodide: From Allergic Rhinitis and Upper Respiratory Conditions to Nasal Cavity Disease

One-Sentence Summary

Potassium iodide was originally used for upper respiratory conditions such as allergic rhinitis, vasomotor rhinitis, pharyngitis, common cold and nasopharyngitis. The TxGNN model predicts it may be effective for nasal cavity disease, but there are 0 registered clinical trials and only 4 publications (all case reports, three of them veterinary) supporting this direction.

Quick Overview

Item	Content
Original Indication	Allergic rhinitis, vasomotor rhinitis, pharyngitis, common cold, nasopharyngitis (from knowledge graph indication edges; no approved indication text on the US licenses)
Predicted New Indication	Nasal cavity disease
TxGNN Prediction Score	99.95%
Evidence Level	L4
US Market Status	Cancelled only (no currently valid licenses)
Number of NDAs	4 (all cancelled)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not currently available. Based on known information, potassium iodide has a long history of use as an expectorant/mucolytic in upper respiratory conditions, and it is also a long-established treatment for certain fungal and fungus-like infections, such as sporotrichosis and, in veterinary medicine, conidiobolomycosis/zygomycosis and pythiosis.

The retrieved literature describes nasal and rhinofacial infections in which potassium iodide (or sodium iodide) was used: pythiosis in sheep, Aspergillus rhinitis and Pseudallescheria boydii infection in horses, and nasofacial zygomycosis in a human patient. This suggests a plausible antifungal/anti-inflammatory link to infectious nasal cavity disease.

However, this link is only partly related to the original indications. Rhinitis, pharyngitis and the common cold rely on the mucolytic/expectorant effect, which is not clearly connected to the fungal conditions above. The evidence also does not support a general “nasal cavity disease” indication. The very high TxGNN score is a computational prediction, not clinical evidence.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
34902797	2022	Case report (veterinary, sheep)	Journal de mycologie medicale	Successful potassium iodide treatment of rhinofacial pythiosis (Pythium insidiosum) in sheep, a disease with necroproliferative masses in the nasal cavity and hard palate
39576399	2024	Case report (veterinary, horse)	Veterinary research communications	Mycotic rhinitis caused by Aspergillus fumigatus in a mare, treated with topical clotrimazole plus oral potassium iodide
10976304	2000	Case report (veterinary, horse)	Journal of the American Veterinary Medical Association	Pseudallescheria boydii infection of the nasal cavity in a gelding, treated with intranasal miconazole and intravenous sodium iodide, among other measures
7997795	1994	Case report (human)	Revista do Instituto de Medicina Tropical de Sao Paulo	Nasofacial zygomycosis in a 64-year-old woman in Pará, Brazil, with rapid response to potassium iodide therapy

US Market Information

All four US authorizations are cancelled. No approved indication text is available for them.

Authorization Number	Product Name	Dosage Form	Approved Indication
NDA018664	IOSAT (Anbex Inc.)	Tablet	Not available (cancelled)
ANDA076350	Thyrosafe (BTG International Inc)	Tablet	Not available (cancelled)
ANDA206211	Potassium Iodide (Mission Pharmacal Company)	Solution	Not available (cancelled)
Not assigned	Kali Iodatum (Hahnemann Laboratories, Inc.)	Pellet	Not available (cancelled)

Safety Considerations

Contraindication signals from the knowledge graph (these are computational associations, not label text): hypertension, liver failure and liver disease, epilepsy, COPD, anxiety and other mental disorders (including psychotic and schizoaffective disorders), porphyria, kidney disease, pancreatitis, gallbladder disease, thrombocytopenia, hypothyroidism (including myxedema and congenital hypothyroidism), peptic ulcer disease, inflammatory bowel disease, dermatitis herpetiformis, diabetes mellitus and diabetic ketoacidosis.
Drug Interactions: 45 known interactions were identified. The 20 examined include:
- Major: ACE inhibitors (benazepril, captopril, enalapril, lisinopril, moexipril, perindopril, quinapril), angiotensin receptor blockers (olmesartan, valsartan, azilsartan medoxomil, losartan, telmisartan) and trimethoprim.
- Moderate: NSAIDs (ketorolac, ibuprofen, diclofenac, oxaprozin, naproxen), aliskiren and tolvaptan.
These combinations are commonly associated with raised potassium, so monitoring would be needed.

Please also refer to the package insert for official warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on a high model score and four case reports, three of them in animals, all describing fungal or fungus-like nasal infections. This does not support a general nasal cavity disease indication. The drug also has no currently valid US license, and there are many significant drug interactions.

To proceed, the following is needed:

Define a narrower, clinically meaningful target, such as fungal or fungus-like nasal infections, instead of “nasal cavity disease”
Human clinical data (controlled studies or larger case series) in that population
Mechanism of action data
FDA package insert warnings and contraindications
A review of the drug interaction profile, especially with ACE inhibitors, ARBs and NSAIDs, and a plan for potassium monitoring
A regulatory pathway given that all US licenses are cancelled
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.