🇺🇸 Requip in United States

FDA authorised Requip on 19 September 1997 · 9,049 US adverse-event reports

Marketing authorisations

FDA — authorised 19 September 1997

  • Application: NDA020658
  • Marketing authorisation holder: GLAXOSMITHKLINE LLC
  • Local brand name: REQUIP
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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 Ineffective — 1,553 reports (17.16%)
  2. Nausea — 1,342 reports (14.83%)
  3. Fall — 915 reports (10.11%)
  4. Fatigue — 915 reports (10.11%)
  5. Dizziness — 803 reports (8.87%)
  6. Somnolence — 795 reports (8.79%)
  7. Insomnia — 770 reports (8.51%)
  8. Pain — 670 reports (7.4%)
  9. Vomiting — 654 reports (7.23%)
  10. Dyspnoea — 632 reports (6.98%)

Source database →

Requip in other countries

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

Other Neuroscience approved in United States

Frequently asked questions

Is Requip approved in United States?

Yes. FDA authorised it on 19 September 1997; FDA has authorised it.

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

GLAXOSMITHKLINE LLC holds the US marketing authorisation.