The complete openFDA result set for both substances, with what each recordoes andoes not contain. The queries are written out below and can be repeated by anyone.
https://open.fda.gov/apis/drug/event/?search=patient.drug.openfda.generic_name:"Chlorine dioxide" https://open.fda.gov/apis/drug/event/?search=patient.drug.openfda.generic_name:"Sodium chlorite"
| Report | Date / sex / age | Co-reportedrugs | Reactions | Assessment |
|---|---|---|---|---|
| 18606804">18606804 | 2021-01-25, M 65 | insulin, saline spray, fish oil, CoQ10 | rectal haemorrhage, diarrhoea | confounded polypharmacy; no dose |
| 19950561">19950561 | 2022-04-25, M 64 | regorafenib, loperamide, buprenorphine | hypertension, AFP fluctuation | matches the regorafenib monograph |
| 21298311">21298311 | 2022-09-05, F 69 | sodium chloride spray, vitamins | throat irritation, asthenia | mild, confounded |
| 22036005">22036005 | 2023-02-21, M 43 | paracetamol/codeine | gastric disorder; unapproved indication | Confounded. Codeine is an opioid and produces opioid-induced bowel dysfunction — delayed gastric emptying and constipation — with gastric discomfort as a recognised adverseffect. No dose recorded. |
| 24204415">24204415 | 2024-08-13, F 1 | amoxicillin | hypoplastic left heart syndrome; foetal exposure | duplicated artifact |
| 24238563">24238563 | 2024-08-22, F 1 | amoxicillin | same record | duplicated artifact |
| 24986615">24986615 | 2025-02-14, F 73 | levothyroxine, rosuvastatin, lisinopril | oral discomfort, dry mouth | non-serious |
| 25766245">25766245 | 2025-09-05, M 75 | relugolix, paracetamol, vitamins | "feeling abnormal" | non-serious |
Totals: deaths recorded — zero. Cases of methemoglobinemia — zero. Reports recording a dose — zero. Reports verifying the ingested substance — zero. Plausibly attributablevents — zero (the single candidate, report 22036005, is confounded by codeine: opioid-induced bowel dysfunction produces exactly the gastric symptoms recorded). Datartifacts — two.
| Report | Date | Substance | Reactions | Note |
|---|---|---|---|---|
| 10473764">10473764 | 2014-09-24, M 55 | sodium chlorite | gastric ulcer, DIC, hyperkalaemia | the frequently cited "ulceration" case — a chlorite salt, undosed |
| 10478410">10478410 | 2014-09-26 | sodium chlorite | internal organ burns, sepsis, suicide attempt | deliberate self-harm ingestion |
| 17846442">17846442 | 2020-05-30, M 24 | sodium chlorite | "poisoning" | no further detail available |
The only reporthat could plausibly be attributed to the product was 22036005: a 43-year-old man with «gastric disorder» while also taking paracetamol with codeine. Codeine is an opioid, and opioids act on thenteric nervousystem to produce opioid-induced bowel dysfunction: delayed gastric emptying, increased reflux and constipation, with nauseand gastric discomfort among the recognised effects. The recorded reaction is precisely thexpected effect of the co-reportedrug.
Sources: Ketwaroo GA, Cheng V, Lembo A. Opioid-induced bowel dysfunction (PMC5297124); Müller-Lissner S, et al. Opioid-induced constipation and bowel dysfunction: a clinical guideline (PMID 28034973); Effect of codeine on gastrointestinal motility, Clin Pharmacol Ther 1997.
Withat report accounted for, the FDA's own file contains no event that can be attributed to chlorine dioxide. This is not a claim of safety — a voluntary database without doses proves nothing in either direction — it is a statement about what the file contains, and therefore about what it cannot be used to assert.
A published tabulation of FAERS counts to 31 March 2020 lists 75,423 reports for acetylsalicylic acid, 70,533 for acetaminophen, 60,097 for ibuprofen, 8,179 for diphenhydramine, 854 for vitamin D3 and 5 for chlorine dioxide. Liester MB, Int J Med Sci 2021;13(2):13–21.
It cannot support a statement that deaths from drinking chlorine dioxide "have been reported to the FDA": no such report exists in it. It equally cannot establish safety, because a voluntary database without doses or substance verification proves nothing in either direction. What it can do is show what the regulatory narrative rests on.