🇺🇸 Golytely in United States

FDA authorised Golytely on 13 July 1984 · 689 US adverse-event reports

Marketing authorisations

FDA — authorised 13 July 1984

  • Application: NDA019011
  • Marketing authorisation holder: AZURITY
  • Status: supplemented

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 — 157 reports (22.79%)
  2. Nausea — 119 reports (17.27%)
  3. Abdominal Pain — 62 reports (9%)
  4. Abdominal Distension — 61 reports (8.85%)
  5. Constipation — 59 reports (8.56%)
  6. Headache — 51 reports (7.4%)
  7. Diarrhoea — 49 reports (7.11%)
  8. Fatigue — 45 reports (6.53%)
  9. Dizziness — 43 reports (6.24%)
  10. Drug Ineffective — 43 reports (6.24%)

Source database →

Golytely in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Golytely approved in United States?

Yes. FDA authorised it on 13 July 1984; FDA has authorised it.

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

AZURITY holds the US marketing authorisation.