🇺🇸 NuLytely in United States

FDA authorised NuLytely on 22 April 1991 · 452 US adverse-event reports

Marketing authorisation

FDA — authorised 22 April 1991

  • Application: NDA019797
  • Marketing authorisation holder: AZURITY
  • Local brand name: NULYTELY
  • Indication: FOR SOLUTION — 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. Vomiting — 68 reports (15.04%)
  2. Nausea — 52 reports (11.5%)
  3. Fall — 46 reports (10.18%)
  4. Confusional State — 44 reports (9.73%)
  5. Drug Interaction — 44 reports (9.73%)
  6. Dyspnoea — 44 reports (9.73%)
  7. Dizziness — 41 reports (9.07%)
  8. Diarrhoea — 38 reports (8.41%)
  9. Hyponatraemia — 38 reports (8.41%)
  10. Pneumonia — 37 reports (8.19%)

Source database →

Other Gastroenterology approved in United States

Frequently asked questions

Is NuLytely approved in United States?

Yes. FDA authorised it on 22 April 1991.

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

AZURITY holds the US marketing authorisation.