🇺🇸 Visicol in United States

FDA authorised Visicol on 21 September 2000 · 233 US adverse-event reports

Marketing authorisation

FDA — authorised 21 September 2000

  • Application: NDA021097
  • Marketing authorisation holder: SALIX PHARMS
  • Local brand name: VISICOL
  • Indication: TABLET — ORAL
  • Status: approved

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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. Renal Failure Acute — 34 reports (14.59%)
  2. Vomiting — 32 reports (13.73%)
  3. Nausea — 31 reports (13.3%)
  4. Asthenia — 23 reports (9.87%)
  5. Dehydration — 23 reports (9.87%)
  6. Hypoaesthesia — 22 reports (9.44%)
  7. Malaise — 20 reports (8.58%)
  8. Renal Failure — 18 reports (7.73%)
  9. Abdominal Pain — 15 reports (6.44%)
  10. Hypocalcaemia — 15 reports (6.44%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Visicol approved in United States?

Yes. FDA authorised it on 21 September 2000.

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

SALIX PHARMS holds the US marketing authorisation.