🇺🇸 Fluoride mouthwash in United States

10 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Accidental Device Ingestion — 1 report (10%)
  2. Face Oedema — 1 report (10%)
  3. Gingival Bleeding — 1 report (10%)
  4. Gingival Pain — 1 report (10%)
  5. Hypersensitivity — 1 report (10%)
  6. Lip Swelling — 1 report (10%)
  7. Nasal Oedema — 1 report (10%)
  8. Oedema Mouth — 1 report (10%)
  9. Oral Mucosal Erythema — 1 report (10%)
  10. Oral Pain — 1 report (10%)

Source database →

Fluoride mouthwash in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Fluoride mouthwash approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fluoride mouthwash in United States?

University of Michigan is the originator. The local marketing authorisation holder may differ — check the official source linked above.