🇺🇸 GnRH in United States

FDA authorised GnRH on 10 October 1989 · 37 US adverse-event reports

Marketing authorisations

FDA — authorised 10 October 1989

  • Application: NDA019687
  • Marketing authorisation holder: FERRING
  • Local brand name: LUTREPULSE KIT
  • Indication: INJECTABLE — INJECTION
  • 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. Ovarian Hyperstimulation Syndrome — 6 reports (16.22%)
  2. Pituitary Haemorrhage — 6 reports (16.22%)
  3. Ectopic Pregnancy — 4 reports (10.81%)
  4. Nausea — 4 reports (10.81%)
  5. Benign Hydatidiform Mole — 3 reports (8.11%)
  6. Drug Exposure During Pregnancy — 3 reports (8.11%)
  7. Headache — 3 reports (8.11%)
  8. Twin Pregnancy — 3 reports (8.11%)
  9. Vision Blurred — 3 reports (8.11%)
  10. Abdominal Pain Lower — 2 reports (5.41%)

Source database →

GnRH in other countries

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

Frequently asked questions

Is GnRH approved in United States?

Yes. FDA authorised it on 10 October 1989; FDA has authorised it.

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

FERRING holds the US marketing authorisation.