🇺🇸 Kyleena in United States

FDA authorised Kyleena on 16 September 2016 · 7,115 US adverse-event reports

Marketing authorisations

FDA — authorised 16 September 2016

  • Application: NDA208224
  • Marketing authorisation holder: BAYER HLTHCARE
  • Local brand name: KYLEENA
  • Indication: SYSTEM — INTRAUTERINE
  • Status: approved

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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. Device Expulsion — 1,985 reports (27.9%)
  2. Device Dislocation — 1,385 reports (19.47%)
  3. Complication Of Device Insertion — 628 reports (8.83%)
  4. Genital Haemorrhage — 620 reports (8.71%)
  5. Drug Ineffective — 600 reports (8.43%)
  6. Abdominal Pain Lower — 571 reports (8.03%)
  7. Pregnancy With Contraceptive Device — 380 reports (5.34%)
  8. Procedural Pain — 380 reports (5.34%)
  9. Ectopic Pregnancy With Contraceptive Device — 323 reports (4.54%)
  10. Pelvic Pain — 243 reports (3.42%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Kyleena approved in United States?

Yes. FDA authorised it on 16 September 2016; FDA has authorised it.

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

BAYER HLTHCARE holds the US marketing authorisation.