🇺🇸 Plenvu in United States

FDA authorised Plenvu on 4 May 2018 · 965 US adverse-event reports

Marketing authorisations

FDA — authorised 4 May 2018

  • Application: NDA209381
  • Marketing authorisation holder: SALIX
  • Local brand name: PLENVU
  • Indication: FOR SOLUTION — ORAL
  • Status: approved

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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. Vomiting — 248 reports (25.7%)
  2. Nausea — 193 reports (20%)
  3. Product Taste Abnormal — 117 reports (12.12%)
  4. Dehydration — 74 reports (7.67%)
  5. Diarrhoea — 72 reports (7.46%)
  6. Dizziness — 61 reports (6.32%)
  7. Headache — 60 reports (6.22%)
  8. Chills — 48 reports (4.97%)
  9. Malaise — 47 reports (4.87%)
  10. Abdominal Pain — 45 reports (4.66%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Plenvu approved in United States?

Yes. FDA authorised it on 4 May 2018; FDA has authorised it.

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

SALIX holds the US marketing authorisation.