FDA
- Status: approved
🇺🇸 KleanLyte in United States
2 US adverse-event reports
Marketing authorisation
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2
Most-reported reactions
- Colon Cancer Stage Iii — 1 report (50%)
- Intestinal Obstruction — 1 report (50%)
KleanLyte 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 KleanLyte approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for KleanLyte in United States?
University of Manitoba is the originator. The local marketing authorisation holder may differ — check the official source linked above.