🇺🇸 Etonogestrel implant in United States

FDA authorised Etonogestrel implant on 17 July 2006 · 633 US adverse-event reports

Marketing authorisations

FDA — authorised 17 July 2006

  • Application: NDA021529
  • Marketing authorisation holder: ORGANON
  • Local brand name: NEXPLANON
  • Indication: IMPLANT — IMPLANTATION
  • 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. Complication Associated With Device — 117 reports (18.48%)
  2. Pregnancy With Implant Contraceptive — 83 reports (13.11%)
  3. Unintended Pregnancy — 78 reports (12.32%)
  4. Device Difficult To Use — 72 reports (11.37%)
  5. No Adverse Event — 55 reports (8.69%)
  6. Device Deployment Issue — 54 reports (8.53%)
  7. Incorrect Drug Administration Duration — 54 reports (8.53%)
  8. Complication Of Device Insertion — 40 reports (6.32%)
  9. Complication Of Device Removal — 40 reports (6.32%)
  10. Incorrect Product Administration Duration — 40 reports (6.32%)

Source database →

Etonogestrel implant 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 Etonogestrel implant approved in United States?

Yes. FDA authorised it on 17 July 2006; FDA has authorised it.

Who is the marketing authorisation holder for Etonogestrel implant in United States?

ORGANON holds the US marketing authorisation.