🇺🇸 Colomycin in United States

274 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. Drug Interaction — 40 reports (14.6%)
  2. Acute Kidney Injury — 34 reports (12.41%)
  3. Hospitalisation — 29 reports (10.58%)
  4. Dizziness — 26 reports (9.49%)
  5. Lower Respiratory Tract Infection — 26 reports (9.49%)
  6. Nausea — 26 reports (9.49%)
  7. Malaise — 25 reports (9.12%)
  8. Vomiting — 24 reports (8.76%)
  9. Dyspnoea — 23 reports (8.39%)
  10. Renal Failure Acute — 21 reports (7.66%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Colomycin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Colomycin in United States?

The Leeds Teaching Hospitals NHS Trust is the originator. The local marketing authorisation holder may differ — check the official source linked above.